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    Somatropin, rh-GH

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    Apr.05.2024

    Somatropin, rh-GH

    Indications/Dosage

    Labeled

    • AIDS-associated wasting syndrome
    • cachexia
    • growth failure
    • growth hormone deficiency
    • Noonan syndrome
    • Prader-Willi syndrome
    • SHOX (short stature homeobox-containing gene) deficiency
    • Turner syndrome

    General Information for use in GH deficiency:

    • The response to somatropin therapy in pediatric patients tends to decline with time. However, the failure to increase growth rate, especially during the first year of therapy, necessitates close assessment of compliance and evaluation for underlying causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human growth hormone.
    • In general, the diagnosis of both adult or childhood onset growth hormone deficiency should be confirmed by an appropriate growth hormone stimulation test. Stimulation testing may not be necessary in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.
    • Clinical response, side effects, and age- and gender-adjusted serum IGF-I levels may be used to guide dose titration. This approach will tend to result in larger doses for women compared to men, smaller doses for adult-onset GHD patients compared with childhood-onset GHD patients, and smaller doses for elderly and obese patients.
    • Patients with childhood onset growth hormone deficiency whose epiphyses are closed should be reevaluated before continuation of somatropin therapy.

    Off-Label

    • HIV-associated lipodystrophy
    † Off-label indication

    For the treatment of growth hormone deficiency, growth failure, or short stature due to various conditions

    for the treatment of adult onset or childhood onset growth hormone deficiency in adults

    Subcutaneous dosage (general dosing)

    Adults older than 60 years

    0.1 to 0.2 mg subcutaneously once daily, initially. Increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Smaller dose increments and longer time intervals may be necessary.[69452]

    Adults 30 to 60 years

    0.2 to 0.3 mg subcutaneously once daily, initially. Increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability.[69452]

    Adults 18 to 29 years

    0.4 to 0.5 mg subcutaneously once daily, initially. The dose may be higher for persons transitioning from pediatric treatment; in persons transitioning from pediatric to adult care, resume treatment at 50% of the dose used in childhood. Increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability.[69452]

    Subcutaneous dosage (Genotropin)

    Adults

    0.15 to 0.3 mg (Usual dose: 0.2 mg) subcutaneously once daily, initially; increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Alternatively, 0.04 mg/kg/week or less subcutaneously in 6 or 7 divided daily doses, initially; increase the dose every 4 to 8 weeks up to 0.08 mg/kg/week based on clinical response, serum IGF-1 concentrations, and tolerability. Persons with obesity are more likely to experience adverse effects when dosed by weight. Consider a lower starting dose and smaller dose increments for older persons.[45045]

    Subcutaneous dosage (Humatrope)

    Adults

    0.15 to 0.3 mg (Usual dose: 0.2 mg) subcutaneously once daily, initially; increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Alternatively, 0.006 mg/kg/dose subcutaneously once daily, initially; increase the dose up to 0.0125 mg/kg/day based on clinical response, serum IGF-1 concentrations, and tolerability. Weight-based dosing is not recommended for persons with obesity as they are more likely to experience adverse effects when dosed by weight. Consider a lower starting dose and smaller dose increments for older persons.[30059]

    Subcutaneous dosage (Norditropin)

    Adults

    0.15 to 0.3 mg (Usual dose: 0.2 mg) subcutaneously once daily, initially; increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Alternatively, 0.004 mg/kg/dose or less subcutaneously once daily, initially; increase the dose after approximately 6 weeks up to 0.016 mg/kg/day based on clinical response, serum IGF-1 concentrations, and tolerability. Persons with obesity are more likely to experience adverse effects when dosed by weight. Consider a lower starting dose and smaller dose increments for older persons.[58095]

    Subcutaneous dosage (Nutropin and Nutropin AQ)

    Adults older than 35 years

    0.15 to 0.3 mg (Usual dose: 0.2 mg) subcutaneously once daily, initially; increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Alternatively, 0.006 mg/kg/dose or less subcutaneously once daily, initially; increase the dose up to 0.0125 mg/kg/day based on clinical response, serum IGF-1 concentrations, and tolerability. Persons with obesity are more likely to experience adverse effects when dosed by weight. Consider a lower starting dose and smaller dose increments for older persons.[49770] [56647]

    Adults 18 to 34 years

    0.15 to 0.3 mg (Usual dose: 0.2 mg) subcutaneously once daily, initially; increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Alternatively, 0.006 mg/kg/dose or less subcutaneously once daily, initially; increase the dose up to 0.025 mg/kg/day based on clinical response, serum IGF-1 concentrations, and tolerability. Persons with obesity are more likely to experience adverse effects when dosed by weight. Consider a lower starting dose and smaller dose increments for older persons.[49770] [56647]

    Subcutaneous dosage (Omnitrope)

    Adults

    0.15 to 0.3 mg (Usual dose: 0.2 mg) subcutaneously once daily, initially; increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Alternatively, 0.04 mg/kg/week or less subcutaneously in 7 divided daily doses, initially; increase the dose every 4 to 8 weeks up to 0.08 mg/kg/week based on clinical response, serum IGF-1 concentrations, and tolerability. Persons with obesity are more likely to experience adverse effects when dosed by weight. Consider a lower starting dose and smaller dose increments for older persons.[45044]

    Subcutaneous dosage (Saizen)

    Adults

    0.15 to 0.3 mg (Usual dose: 0.2 mg) subcutaneously once daily, initially; increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Alternatively, 0.005 mg/kg/dose or less subcutaneously once daily, initially; increase the dose after 4 weeks up to 0.01 mg/kg/day based on clinical response, serum IGF-1 concentrations, and tolerability. Persons with obesity are more likely to experience adverse effects when dosed by weight. Consider a lower starting dose and smaller dose increments for older persons.[56649]

    Subcutaneous dosage (Zomacton)

    Adults

    0.15 to 0.3 mg (Usual dose: 0.2 mg) subcutaneously once daily, initially; increase the dose by 0.1 to 0.2 mg/dose every 1 to 2 months based on clinical response, serum IGF-1 concentrations, and tolerability. Alternatively, 0.006 mg/kg/dose subcutaneously once daily, initially; increase the dose up to 0.0125 mg/kg/day based on clinical response, serum IGF-1 concentrations, and tolerability. Weight-based dosing is not recommended for persons with obesity as they are more likely to experience adverse effects when dosed by weight. Consider a lower starting dose and smaller dose increments for older persons.[59579]

    for the long-term treatment of growth failure in children who have growth hormone deficiency due to inadequate growth hormone secretion

    Subcutaneous dosage (Genotropin)

    Children

    0.16 to 0.24 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections.

    Subcutaneous or Intramuscular dosage (Humatrope)

    Children

    0.18 mg/kg/week (0.54 International Units/kg) subcutaneously or IM divided into equal doses given either on 3 alternate days, 6 times per week, or daily. The maximum replacement dosage is 0.1 mg/kg (0.3 International Units/kg) given 3 times per week. Dosage should be individualized for each patient.

    Subcutaneous dosage (Norditropin)

    Children

    0.024 to 0.034 mg/kg/dose subcutaneously given 6 to 7 times a week. Dosage should be individualized for each patient.[58095]

    Subcutaneous dosage (Nutropin or Nutropin AQ)

    Children

    0.3 mg/kg/week (approximately 0.9 International Units/kg) subcutaneously divided into daily injections is recommended. In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided daily may be used. Dosage should be individualized for each patient.

    Subcutaneous dosage (Nutropin Depot injection suspension)

    Children

    Initially, 1.5 mg/kg subcutaneously on the same day each month or 0.75 mg/kg twice each month on the same days of each month (e.g., days 1 and 15).

    Subcutaneous dosage (Omnitrope)

    Children

    0.16 to 0.24 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections, preferably administered in the evenings.[45044]

    Subcutaneous or Intramuscular dosage (Saizen)

    Children

    0.18 mg/kg/week subcutaneously or IM; the dose can be divided into equal injections administered daily, 3 times/week, or 6 times/week.

    Subcutaneous dosage (Zomacton)

    Children

    0.18 mg/kg to 0.3 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week. Individualize dosage for each patient based on the growth response. If poor growth persists during the first year of treatment, assess compliance and evaluate other causes such as hypothyroidism, under-nutrition, advanced bone age, and antibodies to recombinant human GH.[59579]

    for growth failure due to Prader-Willi syndrome

    Subcutaneous dosage (Genotropin, Omnitrope, or Norditropin)

    Children

    Generally, 0.24 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections.[45044] [45045] [58095] Genotropin or Omnitrope should only be used in Prader-Willi syndrome patients who have a diagnosis of growth hormone deficiency.

    for the long-term treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 to 4

    Subcutaneous dosage (Genotropin)

    Children

    Generally, 0.48 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections for children who have not manifested catch-up growth by age 2. For younger children with a baseline HSDS between -2 and -3, the initial dose is 0.24 mg/kg/week subcutaneously with upwards titration as needed. For children with a baseline HSDS less than -3 or for older/prepubertal children, the recommended initial dose is 0.48 mg/kg/week subcutaneously with a reduction in dosage towards 0.24 mg/kg/week subcutaneously if substantial catch-up growth is seen during the first few years of treatment.

    Subcutaneous dosage (Humatrope and Norditropin)

    Children

    Up to 0.067 mg/kg/day subcutaneously (0.47 mg/kg/week) is recommended. For younger children with a baseline HSDS between -2 and -3, the initial dose is 0.033 mg/kg/day subcutaneously with upwards titration as needed. For children with a baseline HSDS less than -3 or for older/prepubertal children, the recommended initial dose is 0.067 mg/kg/day subcutaneously with a reduction in dosage towards 0.033 mg/kg/day subcutaneously if substantial catch-up growth is seen during the first few years of treatment.

    Subcutaneous dosage (Omnitrope)

    Children

    0.48 mg/kg subcutaneously per week divided into 6 or 7 equal daily injections for children who have not manifested catch-up growth by age 2.[45044]

    Subcutaneous dosage (Zomacton)

    Children

    Up to 0.47 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week. For younger children with a baseline HSDS between -2 and -3, the initial dose is 0.033 mg/kg/day subcutaneously with upwards titration as needed. For children with a baseline HSDS less than -3 or for older/prepubertal children, the recommended initial dose is 0.067 mg/kg/day subcutaneously with a gradual reduction in dosage if substantial catch-up growth is seen during the first few years of treatment.[59579]

    for growth failure associated with chronic renal failure up to the time of transplantation

    Subcutaneous dosage (Nutropin or Nutropin AQ only)

    Children

    0.35 mg/kg (approximately 1.05 International Units/kg) subcutaneously per week divided into daily injections (0.05 mg/kg/day). Dosage should be individualized for each patient. Hemodialysis patients should receive their injection at night just prior to going to sleep or at least 3 to 4 hours after hemodialysis to prevent hematoma formation due to the heparin. Chronic cycling peritoneal dialysis patients should receive their injection in the morning after they have completed dialysis. Chronic ambulatory peritoneal dialysis patients should receive the injection in the evening at the time of the overnight exchange. Nutropin may be continued up to the time of renal transplantation. There are insufficient data regarding the benefit of treatment beyond 3 years. No studies have been completed in patients who have received renal transplants and the use of Nutropin in patients with functioning renal allografts is not indicated.

    for short stature associated with Turner syndrome

    Subcutaneous dosage (Genotropin or Omnitrope)

    Children

    0.33 mg/kg subcutaneously per week divided into equal doses given 6 or 7 times/week. Discontinue treatment with Genotropin or Omnitrope when epiphyses are fused.[45044] [45045]

    Subcutaneous dosage (Humatrope)

    Children

    Up to 0.375 mg/kg (1.125 International Units/kg) subcutaneously per week divided into equal doses given either daily or on 3 alternate days.

    Subcutaneous dosage (Norditropin)

    Children

    Up to 0.067 mg/kg/day subcutaneously is recommended.[58095]

    Subcutaneous dosage (Nutropin or Nutropin AQ)

    Children

    Up to 0.375 mg/kg subcutaneously per week divided into equal doses given 3 to 7 times per week.

    Subcutaneous dosage (Zomacton)

    Children

    Up to 0.375 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week.[59579]

    for short stature in children with SHOX (short stature homeobox-containing gene) deficiency

    Subcutaneous dosage (Humatrope)

    Children

    0.35 mg/kg subcutaneously per week divided into daily injections.

    Subcutaneous dosage (Zomacton)

    Children

    0.35 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week.[59579]

    for short stature in children with Noonan Syndrome

    Subcutaneous dosage (Norditropin only)

    Children

    Up to 0.066 mg/kg/day subcutaneously is recommended. Prior to initiating somatropin, ensure that the patient has short stature. Not all children with Noonan syndrome have short stature. Twenty-four children aged 3 to 14 years of age received doses of 0.033 mg/kg/day subcutaneously or 0.066 mg/kg/day subcutaneously for 2 years; after 2 years, the dose was adjusted based on growth response and continued until final height was achieved. Using the national reference, height gain from baseline increased 1.5 SDS (mean height gain of 9.9 cm in males and 9.1 cm in females at 18 years of age). Using the Noonan reference, height gain from baseline increased 1.6 SDS (mean height gain of 11.5 cm in males and 11 cm in girls at 18 years of age) was noted. During the first 2 years of treatment, height velocity was greater in the group receiving 0.066 mg/kg/day subcutaneously.

    for idiopathic short stature

    Subcutaneous dosage (Genotropin, Omnitrope, or Norditropin)

    Children

    Up to 0.47 mg/kg subcutaneously per week divided into equal doses given 6 to 7 times per week. Discontinue treatment with Genotropin, Omnitrope, or Norditropin when epiphyses are fused.[45044] [45045] [58095]

    Subcutaneous dosage (Humatrope)

    Children

    Up to 0.37 mg/kg subcutaneously per week divided into equal doses given 6 to 7 times per week.

    Subcutaneous dosage (Nutropin or Nutropin AQ)

    Children

    Up to 0.3 mg/kg subcutaneously per week divided into equal doses given once daily every day (i.e., 7 times/week).

    Subcutaneous dosage (Zomacton)

    Children

    Up to 0.37 mg/kg subcutaneously per week, divided into equal injections given 3, 6, or 7 times per week.[59579]

    For the treatment of AIDS-associated wasting syndrome or cachexia to increase lean body mass and body weight, and improve physical endurance; also used for HIV-associated lipodystrophy†

    Subcutaneous dosage (Serostim only)

    Adults

    Dosage is based on weight; 0.1 mg/kg subcutaneously once daily at bedtime, not to exceed 6 mg/day. For weight more than 55 kg: 6 mg subcutaneously once daily at bedtime. For 45 to 55 kg: 5 mg subcutaneously once daily at bedtime. For 35 to 45 kg: 4 mg subcutaneously once daily at bedtime. If less than 35 kg: 0.1 mg/kg subcutaneously once daily at bedtime.[33527]

    Children† and Adolescents† 6 to 17 years

    The manufacturer reports use in pediatric patients in 2 small studies; a total of 11 children with HIV associated failure to thrive were treated. In one study, a dose of 0.04 mg/kg/day subcutaneously for 26 weeks was used in 5 children (6 to 17 years). A second study used a dose of 0.07 mg/kg/day subcutaneously for 4 weeks in 6 children (8 to 14 years). Treatment was reported to be well tolerated and consistent with safety observations in growth hormone treated adults with AIDS wasting.[33527]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

      Patients with Hepatic Impairment Dosing

      Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

      Patients with Renal Impairment Dosing

      Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

      † Off-label indication
      Revision Date: 04/05/2024, 04:08:45 PM

      References

      30059 - Humatrope (somatropin) package insert. Indianapolis, IN: Eli Lilly and Company; 2023 Dec.33527 - Serostim (somatropin injection) package insert. Rockland, MA: EMD Serono, Inc.; 2019 June.45044 - Omnitrope (somatropin) package insert. Princeton, NJ: Sandoz, Inc.; 2016 Dec.45045 - Genotropin (somatropin) package insert. New York, NY: Pharmacia & Upjohn Company; 2016 Dec.49770 - Nutropin (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56647 - Nutropin AQ (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56649 - Saizen (somatropin) package insert. Rockland, MA: EMD Serono Inc; 2017 May.58095 - Norditropin (somatropin) package insert. Plainsboro, NJ: Novo Nordisk; 2017 Feb.59579 - Zomacton (somatropin) package insert. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2024 Apr.69452 - Yuen KCJ, Biller BMK, Radovick S, et al. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of growth hormone deficiency in adults and patients transition from pediatric to adult care. Endocr Pract. 2019;25:1191-1232.

      How Supplied

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      Serostim 6mg Powder for Injection (44087-0006) (EMD Serono, Inc. a business of Merck KGaA, Darmstadt, Germany) (off market)

      Somatropin Lyophilisate for solution for injection [AIDS Wasting/Cachexia]

      Serostim 6mg Powder for Injection (44087-0006) (EMD Serono, Inc. a business of Merck KGaA, Darmstadt, Germany) null

      Somatropin Lyophilisate for solution for injection [AIDS Wasting/Cachexia]

      Serostim 8.8mg Powder for Injection (44087-0088) (EMD Serono, Inc. a business of Merck KGaA, Darmstadt, Germany) (off market)

      Somatropin Lyophilisate for suspension for injection

      Nutropin Depot 13.5mg Powder for Injection (50242-0032) (Genentech Inc) (off market)

      Somatropin Lyophilisate for suspension for injection

      Nutropin Depot 18mg Powder for Injection (50242-0034) (Genentech Inc) (off market)Nutropin Depot 18mg Powder for Injection package photo

      Somatropin Lyophilisate for suspension for injection

      Nutropin Depot 22.5mg Powder for Injection (50242-0036) (Genentech Inc) (off market)Nutropin Depot 22.5mg Powder for Injection package photo

      Somatropin Solution for injection

      Nutropin AQ NuSpin Cartridge 5mg/2ml Solution for Injection (50242-0075) (Genentech Inc) null

      Somatropin Solution for injection

      Norditropin Cartridge 5mg/1.5ml Solution for Injection (00169-7768) (Novo Nordisk Inc.) (off market)Norditropin Cartridge 5mg/1.5ml Solution for Injection package photo

      Somatropin Solution for injection

      Norditropin FlexPro Prefilled Pen 5mg/1.5ml Solution for Injection (00169-7704) (Novo Nordisk Inc.) null

      Somatropin Solution for injection

      Norditropin Nordiflex Prefilled Pen 5mg/1.5ml Solution for Injection (00169-7704) (Novo Nordisk Inc.) (off market)Norditropin Nordiflex Prefilled Pen 5mg/1.5ml Solution for Injection package photo

      Somatropin Solution for injection

      Nutropin AQ 10mg/2ml Solution for Injection (50242-0023) (Genentech Inc) (off market)

      Somatropin Solution for injection

      Nutropin AQ 10mg/2ml Solution for Injection (50242-0022) (Genentech Inc) (off market)Nutropin AQ 10mg/2ml Solution for Injection package photo

      Somatropin Solution for injection

      Nutropin AQ 10mg/2ml Solution for Injection (50242-0114) (Genentech Inc) (off market)

      Somatropin Solution for injection

      Nutropin AQ NuSpin 10 Solution for Injection (50242-0074) (Genentech Inc) null

      Somatropin Solution for injection

      Nutropin AQ Pen Cartridge 10mg/2ml Solution for Injection (50242-0043) (Genentech Inc) (off market)Nutropin AQ Pen Cartridge 10mg/2ml Solution for Injection package photo

      Somatropin Solution for injection

      Omnitrope 5mg/1.5ml Solution for Injection (00781-3001) (Sandoz Inc. a Novartis Company) null

      Somatropin Solution for injection

      Norditropin Cartridge 10mg/1.5ml Solution for Injection (00169-7769) (Novo Nordisk Inc.) (off market)

      Somatropin Solution for injection

      Norditropin FlexPro Prefilled Pen 10mg/1.5ml Solution for Injection (00169-7705) (Novo Nordisk Inc.) null

      Somatropin Solution for injection

      Norditropin Nordiflex Prefilled Pen 10mg/1.5ml Solution for Injection (00169-7705) (Novo Nordisk Inc.) (off market)

      Somatropin Solution for injection

      Nutropin AQ NuSpin 20 Solution for Injection (50242-0076) (Genentech Inc) null

      Somatropin Solution for injection

      Nutropin AQ Pen Cartridge 20mg/2ml Solution for Injection (50242-0073) (Genentech Inc) (off market)

      Somatropin Solution for injection

      Omnitrope 10mg/1.5ml Solution for Injection (00781-3004) (Sandoz Inc. a Novartis Company) null

      Somatropin Solution for injection

      Norditropin Cartridge 15mg/1.5ml Solution for Injection (00169-7770) (Novo Nordisk Inc.) (off market)Norditropin Cartridge 15mg/1.5ml Solution for Injection package photo

      Somatropin Solution for injection

      Norditropin FlexPro Prefilled Pen 15mg/1.5ml Solution for Injection (00169-7708) (Novo Nordisk Inc.) null

      Somatropin Solution for injection

      Norditropin Nordiflex Prefilled Pen 15mg/1.5ml Solution for Injection (00169-7708) (Novo Nordisk Inc.) (off market)Norditropin Nordiflex Prefilled Pen 15mg/1.5ml Solution for Injection package photo

      Somatropin Solution for injection

      Norditropin FlexPro Prefilled Pen 30mg/3ml Solution for Injection (00169-7703) (Novo Nordisk Inc.) null

      Somatropin Solution for injection

      Norditropin Nordiflex Prefilled Pen 30mg/3ml Solution for Injection (00169-7703) (Novo Nordisk Inc.) (off market)

      Somatropin Solution for injection [AIDS Wasting/Cachexia]

      Serostim LQ 6mg/0.5ml Solution for Injection (44087-1006) (EMD Serono, Inc. a business of Merck KGaA, Darmstadt, Germany) (off market)

      Description/Classification

      Description

      Somatropin, rh-GH is a purified recombinant growth hormone prepared by using either Escherichia coli or mammalian-cells. Endogenous human growth hormone (hGH) is produced in the pituitary gland. Somatropin is approved for treating growth hormone deficiency (GHD), growth failure, or short stature. Several somatropin products are available for growth-related indications, all with varying dosage regimens. Care should be taken in product selection as products may not be considered interchangeable. One product (Serostim) is solely approved for treating cachexia and AIDS wasting in adults. Somatropin (Serostim) has been studied in the treatment of HIV-associated lipodystrophy; limited data indicate use may decrease visceral adipose tissue, but this is still not an FDA-approved use. One product (Zorbtive) was approved to treat adults with short bowel syndrome, but is no longer marketed. Somatropin was originally approved by the FDA in 1987.

      Classifications

      • Systemic Hormonal Agents (excluding Sex Hormones)
        • Other Hormones
          • Growth Hormones
      Revision Date: 04/05/2024, 04:08:45 PM

      References

      Administration Information

      General Administration Information

      For storage information, see the specific product information within the How Supplied section.

      Route-Specific Administration

      Injectable Administration

      • Administer somatropin by intramuscular or subcutaneous injection. Do NOT administer intravenously.
      • Monitor height, weight, and bone age. Discontinue therapy if final height is achieved or epiphyseal fusion occurs.
      • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
      • Each somatropin cartridge is designed for use only with the appropriate corresponding pen; confirm cartridge and pen match prior to administration.[30059][45045]

       

      Genotropin:

      • This product is supplied as a powder, filled in a two-chamber cartridge with the active substance in the front chamber and the diluent in the rear chamber. The product is available in a 5 mg cartridge (green tip) and a 12 mg cartridge (purple tip). The 5 and 12 mg cartridges can be used with the Genotropin Pen or the Genotropin Mixer. Genotropin is also available, in various doses ranging from 0.2 mg to 2 mg, in single use, auto-mix devices called Genotropin Miniquicks.
      • Cartridges: A reconstitution device supplied by the manufacturer is used to mix the powder and the diluent. After the powder and diluent are mixed, gently tip the cartridge upside down a few times until completely dissolved. DO NOT SHAKE; this may cause denaturation of the protein. If the solution is cloudy, do not use. Following reconstitution, the 5 mg cartridge will contain a 5 mg/mL solution and the 12 mg cartridge will contain a 12 mg/mL solution; both the 5 mg and 12 mg cartridges contain overfill. The cartridges contain diluent with preservative (m-cresol) and may be stored under refrigeration for up to 28 days after reconstitution. Do not use the 5 mg and 12 mg cartridges in patients with m-cresol hypersensitivity.
      • Miniquicks: A reconstitution device supplied by the manufacturer is used to mix the powder and diluent. Ten different strengths are available that each deliver a fixed volume of 0.25 mL. This product contains a diluent with no preservative, therefore, refrigerate after reconstitution and use within 24 hours. Use the reconstituted solution only once and discard any remaining solution.[45045]

       

      Humatrope:

      • Reconstitute cartridges using ONLY the supplied diluent syringe; the cartridges are designed for use only with the Humatrope injection device.
      • Do not shake.
      • The reconstituted solution should be clear. If the resulting solution is cloudy or contains particulate matter, do not use.
      • Once reconstituted, the cartridges are stable for up to 28 days when stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). Do not leave at room temperature for more than 30 minutes per day. Store the injection device without the needle attached. Avoid freezing reconstituted solutions. Protect from light.[30059]

       

      Norditropin:

      • Do not use if solution is cloudy or contains particulate matter.
      • Once a Norditropin pen is in use, the pen should be stored in the refrigerator (2 to 8 degrees C; 36 to 46 degrees F), and used within 4 weeks. Alternatively, the Norditropin pens may be stored at room temperatures, no higher than 25 degrees C (77 degrees F), for up to 3 weeks. NovoFine needles are recommended for administration. Wipe the stopper on the needle thread with rubbing alcohol to prevent contamination.[56238]

       

      Nutropin:

      • Reconstitute each 5 mg vial with 1 to 5 mL Bacteriostatic Water for Injection (benzyl alcohol preserved) and each 10 mg vial with 1 to 10 mL of Bacteriostatic Water for Injection (benzyl alcohol preserved). If using for newborns, reconstitute with Sterile Water for Injection. Direct the liquid against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. If the solution is cloudy after reconstitution or refrigeration, do not use. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins. The pH after reconstitution with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) is approximately 7.4.
      • Solutions reconstituted with Bacteriostatic Water for Injection are stable for 14 days under refrigeration, 2 to 8 degrees C (36 to 46 degrees F). Solutions reconstituted with Sterile Water for Injection should be used immediately and only once; discard any unused portions. Avoid freezing reconstituted solutions.[49770]

       

      Nutropin AQ:

      • Does not require reconstitution. Solution should be clear. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins. Allow vial or pen cartridge to come to room temperature and gently swirl. If solution is cloudy, do not use.
      • Vials: Before needle insertion, wipe the vial septum with rubbing alcohol or antiseptic solution to prevent contamination by microorganisms that may be introduced by repeated needle insertions. Administer using sterile, disposable syringes and needles. Use syringes with small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.
      • Pen cartridge: Two strengths are available, 10 mg and 20 mg; intended for use only with Nutropin AQ Pen. Each pen and cartridge are color coded to ensure accurate placement of the 10 mg or 20 mg cartridge into the appropriate pen. Do not use the 20 mg cartridge in the pen intended for the 10 mg cartridge, and vice versa. Wipe septum of pen cartridge with rubbing alcohol or antiseptic solution to prevent contamination by microorganisms that may be introduced by repeated needle insertions. Administered using sterile, disposable needles. Follow the directions provided in the Nutropin AQ Pen Instructions for Use. The Nutropin AQ 10 pen allows for administration of a minimum 0.1 mg dose to a maximum 4 mg dose, in 0.1 mg increments. The Nutropin AQ 20 pen allows for administration of a minimum 0.2 mg dose to a maximum 8 mg dose, in 0.2 mg increments.
      • Prefilled device: A prefilled multi-dose, dial a dose device is available in 3 strengths. Administer using disposable needles. Follow the directions provided in the Nutropin AQ NuSpin Instruction for Use. The Nutropin AQ Nuspin 5 allows for administration of a minimum dose of 0.05 mg to a maximum dose of 1.75 mg, in increments of 0.05 mg. The Nutropin AQ Nuspin 10 allows for administration of a minimum dose of 0.1 mg to a maximum dose of 3.5 mg, in increments of 0.1 mg. The Nutropin AQ Nuspin 20 allows for administration of a minimum dose of 0.2 mg to a maximum dose of 7 mg, in increments of 0.2 mg.
      • After initial use, vials, cartridges, and prefilled devices are stable for 28 days when stored under refrigeration, 2 to 8 degrees C (36 to 46 degrees F); avoid freezing. Vials, cartridges, and prefilled devices are light sensitive; protect from light.[56647]

       

      Omnitrope:

      • Vials: Reconstitute the vial with diluent provided using a sterile, disposable syringe. Swirl the vial gently, but do not shake. If the solution is cloudy after reconstitution, the contents must not be injected. After reconstitution, the 1.5 mg vial may be stored under refrigeration, 2 to 8 degrees C (36 to 46 degrees F), for up to 24 hours. The 1.5 mg vial does not contain a preservative and should only be used once; discard any remaining solution. The 5.8 mg vial diluent contains benzyl alcohol as a preservative. After reconstitution, the contents must be used within 3 weeks. After the first injection, store the 5.8 mg vial in the carton, to protect from light, in the refrigerator at 2 to 8 degrees C (36 to 46 degrees F). Avoid freezing.
      • OmnitropePen 5 cartridge: Each 5 mg cartridge must be inserted into the Omnitrope Pen 5 delivery system. Follow the directions provided in the Omnitrope Instructions for Use. The cartridge contains benzyl alcohol as a preservative. Once initially used, store under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 28 days. Protect from light. Avoid freezing.
      • Omnitrope Pen 10 cartridge: Each 10 mg cartridge must be inserted into the Omnitrope Pen 10 delivery system. Follow the directions provided in the Omnitrope Instructions for Use. Once initially used, store under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 28 days. Protect from light. Avoid freezing.[45044]

       

      Saizen:

      • Vials: Reconstitute each 5 mg vial with 1 to 3 mL Bacteriostatic Water for Injection; reconstitute each 8.8 mg vial with 2 to 3 mL Bacteriostatic Water for Injection (benzoyl alcohol preserved). In patients with hypersensitivity to benzyl alcohol, the vials can be mixed with Sterile Water for Injection. Direct the liquid against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. The solution should be clear; if it is cloudy immediately after reconstitution or refrigeration, do not use. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins. After reconstitution, store vials mixed with bacteriostatic water for injection under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) and use within 14 days. For vials mixed with Sterile Water for Injection, the solution should be used immediately, and any unused portion should be discarded. Avoid freezing.
      • Cartridges: Available in 4 mg and 8.8 mg click.easy cartridges for use in a compatible injection device. A reconstitution device supplied by the manufacturer is used to mix the Saizen with accompanying diluent containing metacresol. Cartridges reconstituted with the diluent containing metacresol are stable under refrigeration for up to 21 days. Avoid freezing.[56649]

       

      Serostim:

      • Reconstitute the 5 mg or 6 mg vials with 0.5 to 1 mL of Sterile Water for Injection - supplied with the vial.
      • Reconstitute the 4 mg vial with 0.5 to 1 mL of Bacteriostatic Water for Injection (benzyl alcohol preserved) - supplied with the vial.
      • Direct the supplied diluent against the glass vial wall. Swirl vial with a gentle rotary motion until contents are dissolved completely. Do not shake. The solution should be clear; if it is cloudy immediately after reconstitution or refrigeration, do not use. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins.
      • Storage: If reconstituted with Sterile Water for Injection, use within 24 hours. If reconstituted with Bacteristatic Water for Injection (benzyl alcohol preserved), the solution is stable for up to 14 days under refrigeration (2 to 8 degrees C or 36 to 46 degrees F). Avoid freezing.[33527]

       

      Zomacton:

      • Reconstitute the 5 mg vial with 1 to 5 mL of supplied diluent (Bacteriostatic Water for Injection with benzyl alcohol) and the 10 mg vial with 1 mL of supplied diluent (Bacteriostatic Water for Injection with metacresol). When reconstituting for neonates or pregnant or lactating persons, use 0.9% Sodium Chloride Injection (unpreserved). Direct the liquid against the glass vial wall to prevent foaming. Swirl vial gently until contents are dissolved completely. Do not shake. The solution should be clear; if it is cloudy immediately after reconstitution, do not inject. Small, colorless particles may be present after refrigeration; this is not unusual for solutions containing proteins.
      • Administer using a standard sterile disposable syringe.
      • Storage: After reconstitution with Bacteriostatic 0.9% NaCl Injection, the solution may be stored under refrigeration (2 to 8 degrees C or 36 to 46 degrees F) for up to 14 days. After reconstitution with Bacteriostatic Water for Injection (containing 0.33% metacresol), the solution may be stored under refrigeration (2 to 8 degrees C or 36 to 46 degrees F) for up to 28 days. Solution reconstituted using 0.9% NaCl Injection (containing no preservative) should be used only once, with any remaining solution discarded. Do not freeze reconstituted solutions.[59579]

      Intramuscular Administration

      • Inject somatropin deeply into a large muscle. Aspirate prior to injection to avoid injection into a blood vessel. Rotate injection sites daily.

      Subcutaneous Administration

      • Subcutaneous injection of somatropin volumes greater than 1 mL of reconstituted solution is not recommended. Inject subcutaneously taking care not to inject intradermally.
      • Allow refrigerated solutions to come to room temperature prior to injection.
      • Subcutaneous injections may be given in the thigh, buttocks, or abdomen. Rotate injection sites daily.

      Clinical Pharmaceutics Information

      From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database

      Somatropin

      pH Range
      pH differs among the products. Genotropin- pH 6.7 Humatrope- pH 7.5 Norditropin- pH 7.3 Nutropin- pH 7.4 Nutropin AQ- pH 6.0 Nutropin Depot- pH 5.8 to 7.2 Saizen- pH 6.5 to 8.5 Serostim- pH 7.4 to 8.5
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      Stability
      Somatropin injection in intact containers stored as directed by the manufacturer is stable until the labeled expiration date. The stability period of reconstituted somatropin products is as variable as their other product aspects. Use of a preservative-containing diluent results in longer recommended use periods after reconstitution than those reconstituted with an unpreserved diluent. Freezing of reconstituted or liquid forms of somatropin should be avoided. The manufacturers' recommendations for the stability periods of the various products stored under refrigeration are shown below. Using an Unpreserved Diluent: Genotropin 1.5 mg- 24 hours Humatrope- 24 hours Nutropin Depot- Use immediately; discard remainder Serostim- 24 hours Using a Preserved Diluent: Genotropin 5.8, 13.8 mg- 21 days Humatrope- 28 days Norditropin- 14 days Nutropin- 14 days Nutropin AQ- 28 days from penetration of stopper Saizen- 14 days Packaged in Syringes: Ray and Chen reported that Humatrope reconstituted to concentrations of 1 and 3.33 mg/mL with the accompanying diluent (composed of glycerin 1.7% with meta-cresol 0.3% preservative) and packaged in Becton Dickinson polypropylene syringes and Terumo propylene-ethylene copolymer syringes sealed with tip caps was chemically stable for 28 days under refrigeration. HPLC analysis found no loss of somatropin and little change in the preservative concentration during this period. The samples in polypropylene syringes remained clear throughout 28 days of refrigerated storage as well. However, in the propylene-ethylene syringes cloudiness had formed at the 21-day point limiting the use period to 14 days.
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      ReferencesRay LR, Chen DA. Stability of somatotropin stored in plastic syringes for 28 days. Am J Health-Syst Pharm. 1998; 55
      Light Exposure
      Genotropin and Norditropin should be protected from exposure to light during long-term storage. Kerwin and Remmele reported photo-oxidation of histidine in somatropin in the presence of metal ions.
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      ReferencesKerwin BA, Remmele Jr RL. Protect from light: photodegradation and protein biologics. J Pharm Sci. 2007; 96
      Freezing
      Somatropin products including reconstituted formulations should be protected from freezing.
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      Other Information
      Trade Names: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Nutropin Depot, Saizen, Serostim Reaction with Heparin: Zamiri and Groves reported that somatropin (Norditropin, Novo Nordisk) interacts with heparin forming adducts that result in a stabilization of the somatropin, a relatively unstable protein. Although somatropin activity of the adduct is rats was found to be comparable to the somatropin alone, further studies are necessary to elucidate and fully characterize the interaction and its effects. Until then, avoiding the interaction by keeping somatropin and heparin separated to preclude the interaction should be considered.
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      ReferencesZamiri C, Groves MJ. Stabilization of somatropin by heparin. J Pharm Pharmacol. 2005; 57
      Revision Date: 04/05/2024, 04:08:45 PMCopyright 2004-2024 by Lawrence A. Trissel. All Rights Reserved.

      References

      30059 - Humatrope (somatropin) package insert. Indianapolis, IN: Eli Lilly and Company; 2023 Dec.33527 - Serostim (somatropin injection) package insert. Rockland, MA: EMD Serono, Inc.; 2019 June.45044 - Omnitrope (somatropin) package insert. Princeton, NJ: Sandoz, Inc.; 2016 Dec.45045 - Genotropin (somatropin) package insert. New York, NY: Pharmacia & Upjohn Company; 2016 Dec.49770 - Nutropin (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56238 - Zomig (zolmitriptan) nasal spray package insert. Hayward, CA: Impax Specialty Pharma; 2015 Jun.56647 - Nutropin AQ (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56649 - Saizen (somatropin) package insert. Rockland, MA: EMD Serono Inc; 2017 May.59579 - Zomacton (somatropin) package insert. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2024 Apr.

      Adverse Reactions

      Mild

      • abdominal pain
      • acne vulgaris
      • alopecia
      • arthralgia
      • asthenia
      • back pain
      • carpal tunnel syndrome
      • cough
      • diaphoresis
      • diarrhea
      • dizziness
      • fatigue
      • fever
      • gynecomastia
      • headache
      • hypoesthesia
      • injection site reaction
      • insomnia
      • maculopapular rash
      • musculoskeletal pain
      • myalgia
      • nausea
      • paresthesias
      • pruritus
      • rash
      • rhinitis
      • skin hyperpigmentation
      • vomiting
      • weakness

      Moderate

      • anemia
      • antibody formation
      • bleeding
      • chest pain (unspecified)
      • depression
      • diabetes mellitus
      • edema
      • elevated hepatic enzymes
      • eosinophilia
      • erythema
      • fluid retention
      • gastritis
      • hematoma
      • hematuria
      • hyperglycemia
      • hyperlipidemia
      • hypertension
      • hypertriglyceridemia
      • hypoglycemia
      • hypothyroidism
      • peripheral edema
      • psoriasis

      Severe

      • anaphylactoid reactions
      • angioedema
      • diabetic ketoacidosis
      • increased intracranial pressure
      • new primary malignancy
      • pancreatitis
      • papilledema
      • seizures

      0

      • infection

      Somatropin has been associated with an increased risk of a new primary malignancy. Leukemia has been reported in a small number of growth hormone deficient patients treated with somatropin. It is uncertain if this increased risk is related to the pathology of growth hormone deficiency itself, growth hormone therapy, or other associated treatments such as radiation therapy for intracranial tumors. Additionally, in childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent growth hormone deficiency and were treated with somatropin, an increased risk of a new primary malignancy has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. It is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence in adults. Increases in the size or number of cutaneous nevi were reported during postmarketing surveillance.[58095] Monitor all patients with a history of growth hormone deficiency secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor. Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms. Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi. Somatropin therapy should be discontinued if evidence of neoplasia develops.[30059] [56647]

      In trials of growth hormone deficient (GHD) adults, rates of edema or peripheral edema have varied according to the brand of somatropin used and ranged from approximately 5% to 45%. In children with GHD, the rates have been approximately 3%. The edema appears to occur early in therapy and may be transient and/or respond to a dose reduction. Both fluid retention and peripheral edema have been commonly reported in patients receiving somatropin. Peripheral edema is more common in adults than children.[33527] [45045] [56647] [56649] [58095] [30059]

      Increased intracranial pressure (intracranial hypertension), with papilledema, visual changes, severe head pain, nausea, and vomiting, has been reported in a small number of patients treated with growth hormone products. Symptoms usually occur within the first 8 weeks of treatment initiation. In all reported cases, symptoms resolved after termination of therapy or a reduction in dose. Funduscopic examination of patients is recommended upon initiation of therapy and periodically throughout treatment. If papilledema is observed during treatment, somatropin should be stopped. If intracranial hypertension is diagnosed, the treatment can be restarted at a lower dose. Patients with Turner syndrome may also be at an increased risk for developing intracranial hypertension.[30059]

      Joint swelling (5—6%), myalgia (3—30%), musculoskeletal pain (5—14%), pain and stiffness of the extremities (2—19%), and back pain (3—11%) have been commonly associated with somatropin therapy. Some events are related to fluid retention and appear to occur more frequently in adults than in children, particularly arthralgia (11—37%). In adults treated with somatropin, muscle and joint pain usually occurred early in therapy and tended to be transient or respond to dosage reduction. Pain, swelling and/or stiffness may resolve with analgesic use or a reduction in frequency of dosing with somatropin. In addition, carpal tunnel syndrome (nerve entrapment syndrome, 1—5%) and arthrosis (8—11%), have also been reported. More serious adverse reactions that have been reported include slipped capital femoral epiphysis and progression of scoliosis (4—19%) in pediatric patients.[30059] [33527] [45044] [45045] [56647] [56649] [58095]

      Metabolic complications have been frequently reported with somatropin therapy. During postmarketing surveillance of various products, there have been cases of new onset glucose intolerance, hyperglycemia, diabetes mellitus, and exacerbation of pre-existing diabetes mellitus.[30059] Some patients developed diabetic ketoacidosis and diabetic coma.[33527] [60682] Discontinuing treatment led to improvement in some patients, while glucose intolerance persisted in others. Monitor glucose concentrations closely during therapy; initiate or adjust antidiabetic treatment as necessary. Short-term overdosage may result in hypoglycemia.[30059] A greater incidence of impaired fasting glucose has been observed with higher doses. During clinical trials, Type 2 diabetes mellitus (DM) was reported in 5% of adults receiving somatropin.[58095] Hypothyroidism has been reported in approximately 5% to 16% of patients receiving somatropin therapy.[45044] [56649] During a 6 month placebo-controlled trial in growth hormone deficient (GHD) adults using the Saizen brand, approximately 10% required small upward adjustments of thyroid hormone replacement therapy for preexisting hypothyroidism, and 1 patient was newly diagnosed with hypothyroidism. Additionally, during the trial, 2 patients required upward adjustments of hydrocortisone maintenance therapy (unrelated to intercurrent stress, surgery, or disease) for preexisting hypoadrenalism, and 1 patient was newly diagnosed with adrenal insufficiency. Monitor thyroid tests periodically and initiate or adjust thyroid replacement therapy as necessary.[56649] Hyperlipidemia (8%) has also been reported, most often as hypertriglyceridemia (1% to 5%).[30059] [33527]

      The most common central nervous system (CNS) adverse reactions reported in somatropin clinical trials were in adults and include headache (6—18%), paresthesias (2—17%), and hypoesthesia (2—15%). Asthenia or weakness (3—6%), fatigue (4—9%), insomnia (5%), depression (5%) and dizziness were also reported in trials.[30059] [33527] [45045] [56649] [58095] [60682] Seizures have been reported rarely.[56649]

      Upper respiratory tract infection (32%) and fever (16%) have been reported in pediatric patients receiving somatropin.[59579] Naso-pharyngitis (3% to 14%), bronchitis (9%), rhinitis (5% to 14%), and flu like symptoms (4% to 23%) have been reported in somatropin-treated patients during clinical trials.[30059] [45045] [58095] Children with Turner syndrome reported otitis media (16% to 43%) and ear disorders (18%).[30059] Otitis media was reported in 10% of pediatric patients treated with somatropin for short stature due to growth hormone deficiency.[59579] In studies with Norditropin, otitis media and otitis externa were reported more frequently in patients receiving the highest doses.[58095] Increased cough (6% to 9%) has also been reported.[30059] [59579]

      Somatropin administration is associated with an injection site reaction (pain or burning associated with injection), lipoatrophy, or nodule formation; lipoatrophy can be avoided by frequent rotation of the injection site. Other injection site reactions include hematoma (9%), fibrosis, erythema, pruritus, rash, swelling, bleeding, and skin hyperpigmentation.[45044] [45045] [56649]

      Antibody formation occurs in approximately 2% of patients receiving somatropin. Growth hormone antibody binding capacities below 2 mg/L have not been associated with growth attenuation; however, in some cases when binding capacity exceeds 2 mg/L growth attenuation has been observed. Testing for growth hormone antibodies should be performed in any patient who fails to respond to somatropin therapy.[30059] [45045]

      During postmarketing experience with somatropin, dermatologic and serious systemic hypersensitivity reactions including anaphylactoid reactions and angioedema have been reported.[30059] [33527] [45044] [45045] [49770] [56646] [56647] [56649] [58095] [59579] Acne vulgaris (6%), diaphoresis (8%), maculopapular rash (6%), alopecia, and eczema have been reported in patients taking somatropin therapy.[30059] [45045] [58095] [59579] Allergic reactions are possible and include rash; exacerbation of pre-existing psoriasis has also been reported.[56649]

      Pancreatitis has been rarely reported in adults and children receiving somatropin, with children, and especially girls with Turner syndrome, appearing to be at greater risk compared to adults. Evaluate any patient who develops abdominal pain for pancreatitis. Other gastrointestinal adverse reactions reported in clinical trials include elevated hepatic enzymes (6% to 13%), abdominal pain (7%), gastritis (6%), gastroenteritis (8%), and diarrhea (5%). An increase in blood alkaline phosphatase concentration and a decrease in serum thyroxin (T4) concentrations have been reported during postmarketing surveillance.[30059] [45045] [58095] [59579]

      Gynecomastia has been observed in both adults (3—6%) and children (5—8%) treated with somatropin in clinical trials.[30059] [33527]

      Hypertension (3% to 8%) and chest pain (unspecified) (5%) have been reported in patients treated with somatropin in clinical trials.[30059] [56649] [58095] Eosinophilia (12%), anemia (6%), and pain (5%) have been reported in pediatric patients receiving somatropin in clinical trials.[45044] [59579] Hematuria has been rarely observed.[45045]

      Revision Date: 04/05/2024, 04:08:45 PM

      References

      30059 - Humatrope (somatropin) package insert. Indianapolis, IN: Eli Lilly and Company; 2023 Dec.33527 - Serostim (somatropin injection) package insert. Rockland, MA: EMD Serono, Inc.; 2019 June.45044 - Omnitrope (somatropin) package insert. Princeton, NJ: Sandoz, Inc.; 2016 Dec.45045 - Genotropin (somatropin) package insert. New York, NY: Pharmacia & Upjohn Company; 2016 Dec.49770 - Nutropin (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56646 - Accretropin (somatropin) package insert. Winnipeg, Canada: Cangene Corporation; 2016 Dec.56647 - Nutropin AQ (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56649 - Saizen (somatropin) package insert. Rockland, MA: EMD Serono Inc; 2017 May.58095 - Norditropin (somatropin) package insert. Plainsboro, NJ: Novo Nordisk; 2017 Feb.59579 - Zomacton (somatropin) package insert. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2024 Apr.60682 - Zorbtive (somatropin) injection package insert. Rockland, MA: EMD Serono, Inc.; 2017 May.

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • diabetic retinopathy
      • epiphyseal closure
      • history of angioedema
      • neoplastic disease
      • obesity
      • trauma
      • adrenal insufficiency
      • benzyl alcohol hypersensitivity
      • breast-feeding
      • chemotherapy
      • children
      • cresol hypersensitivity
      • diabetes mellitus
      • females
      • geriatric
      • glycerin hypersensitivity
      • hypothyroidism
      • increased intracranial pressure
      • neonates
      • new primary malignancy
      • otitis media
      • pancreatitis
      • pregnancy
      • radiation therapy
      • renal impairment
      • renal osteodystrophy
      • respiratory infection
      • respiratory insufficiency
      • scoliosis
      • serious hypersensitivity reactions or anaphylaxis
      • sleep apnea
      • surgery

      In August 2011, the FDA notified healthcare professionals that it has reviewed data from the SAGhE (Sante Adulte GH Enfant) study (a long-term epidemiological study conducted in France). The SAGhe Study found that patients with idiopathic growth hormone deficiency and idiopathic or gestational short stature treated with somatropin during childhood had a 30% increased risk of death compared to the general population. The FDA determined this evidence regarding recombinant human growth hormone and increased risk of death to be inconclusive.[45269] A 2016 study devised an advanced mortality model using the the Swedish Medical Birth Registry to estimate standardized mortality rates in patients receiving growth hormone compared to the general population. The authors concluded that the increase in mortality found in the SAGhE study was most likely related to basic characteristics of the growth hormone deficiency population (i.e. birth weight, birth length, and congenital malformations) rather than due to the use of growth hormone treatment itself.[61679]

       

      Somatropin therapy may cause changes in some laboratory values. Serum levels of inorganic phosphorus, alkaline phosphatase, and parathyroid hormone may increase with somatropin therapy.

      Somatropin products are contraindicated in patients with a known hypersensitivity to somatropin or any of the product excipients, such as a history of angioedema. Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products. Patients and caregivers should be informed that there is a risk of serious hypersensitivity reactions or anaphylaxis and that prompt medical attention should be sought if an allergic reaction occurs.[30059] [33527] [45044] [45045] [49770] [56646] [56647] [56649] [58095] [59579] As with any hormonal product, local or systemic allergic reaction may occur. Several of the products contain m-cresol as a preservative. Some of the formulations recommend using sterile water for injection as a diluent in patients with m-cresol hypersensitivity; other products recommend using other formulations. The package insert of the specific product should be consulted for further information when using somatropin in patients with m-cresol hypersensitivity. Similarly, some of the formulations also contain glycerin. Do not use formulations of somatropin that contain glycerin in patients with glycerin hypersensitivity.

      Somatropin is contraindicated for growth promotion in pediatric patients with epiphyseal closure. Linear growth can no longer occur in these patients. In addition, slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Pediatric patients with the onset of a limp or complaints of hip or knee pain should be evaluated for slipped capital femoral epiphysis.[59579]

      Response to somatropin therapy in children tends to decrease over time. However, in children in whom growth rate is not increased, especially during the first year of treatment, compliance as well as other causes of growth failure including thyroid abnormalities, malnutrition, advanced bone age, and antibodies to somatropin should be assessed. Any child taking somatropin that complains of hip or knee pain or the development of a limp should be evaluated by a clinician. Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in children undergoing rapid growth. In addition, children with growth failure secondary to renal impairment should be evaluated for progression of renal osteodystrophy. Slipped capital femoral epiphysis or avascular necrosis of the femoral head may occur in children with advanced renal osteodystrophy; x-rays of the hip should occur prior to initiating therapy with somatropin. In August 2011, the FDA notified healthcare professionals that it has reviewed data from the SAGhE (Sante Adulte GH Enfant) study (a long-term epidemiological study conducted in France), which found that patients with idiopathic growth hormone deficiency and idiopathic or gestational short stature treated with somatropin during childhood had a 30% increased risk of death compared to the general population. The FDA has determined the evidence regarding recombinant human growth hormone and increased risk of death to be inconclusive; a number of study design weaknesses were found which limit the interpretability of the study results. Additionally, the FDA reviewed the medical literature, as well as reports from the Agency's Adverse Event Reporting System (AERS). The FDA will continue to review this safety issue and expects to receive additional data from the SAGhE study in Spring 2012. The FDA will update the public when new information is available. Healthcare professionals and patients should continue to prescribe and use recombinant human growth hormone according to the labeled recommendations.[45269] 

      Some of the multi-dose somatropin products contain benzyl alcohol and should be used cautiously in neonates and patients with benzyl alcohol hypersensitivity. Benzyl alcohol has been associated with toxicity in newborns. If somatropin is to be used in neonates or in patients with benzoyl alcohol hypersensitivity, sterile water for injection, USP should be used for reconstitution and only one dose should be used per vial.

      Somatropin is contraindicated in patients with active neoplastic disease. Any pre-existing neoplastic disease, specifically intracranial lesions (including pituitary tumors) must be inactive, and chemotherapy and radiation therapy complete, prior to beginning somatropin therapy. In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent growth hormone deficiency and were treated with somatropin, an increased risk of a new primary malignancy has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. It is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence in adults. Monitor all patients with a history of growth hormone deficiency secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor. Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms. Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi. Somatropin therapy should be discontinued if evidence of neoplasia develops.[56647]

      Somatropin is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or to patients having acute respiratory insufficiency. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (41.9% vs. 19.3%) among somatropin-treated patients (5.3—8 mg/day) compared to those receiving placebo. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who currently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients having acute critical illnesses should be weighed against the potential risk. Additionally, somatropin is contraindicated for use in pediatric patients with Prader-Willi syndrome and respiratory insufficiency as there have been reports of fatalities (see Prader-Willi discussion).

      The manufacturers of Genotropin and Norditropin indicate that adult patients with obesity receiving somatropin for growth hormone deficiency may be more likely to experience adverse events when dosed by weight (see Dosage). Using a daily dose that is not weight-based may be preferable. Additionally, somatropin is contraindicated for use in pediatric patients with Prader-Willi syndrome and obesity as there have been reports of fatalities (see Prader-Willi discussion).

      Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, somatotropin is not indicated for long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. There have been reports of fatalities with the use of growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of respiratory insufficiency or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at increased risk. Patients with Prader-Willi syndrome should be evaluated for upper airway obstruction before initiation of treatment with growth hormone. If during treatment with growth hormone patients show signs of upper airway obstruction (including onset of or increased snoring), treatment should be interrupted. All patients with Prader-Willi syndrome should be evaluated for sleep apnea and monitored if sleep apnea is suspected. All patients with Prader-Willi syndrome should also have effective weight control and be monitored for signs of respiratory infections, which should be diagnosed as early as possible and treated aggressively. Patients with Prader-Willi syndrome may also be at increased risk of intracranial hypertension.

      Somatropin should be used cautiously in patients with diabetes mellitus. Patients with diabetes or glucose intolerance and those patients with risk factors for diabetes or glucose intolerance should be monitored closely during treatment with somatropin. Risk factors for glucose intolerance include obesity (including obese patients with Prader-Willi Syndrome), Turner syndrome, or a family history of type II diabetes. Because somatropin may reduce insulin sensitivity, especially at higher doses, patients should be monitored for evidence of glucose intolerance. Glucose intolerance or acromegaly may occur with chronic overdosage of somatropin. Dose adjustments of antidiabetic medications may be necessary when somatropin is initiated. Due to the effects of somatropin on insulin sensitivity and blood glucose concentrations, somatropin is contraindicated in patients with diabetic retinopathy.[30059]

      Patients with a history of scoliosis should receive somatropin with caution. Because growth hormone increases growth rate, patients with scoliosis can experience progression of scoliosis. Patients should be monitored for progression of scoliosis. In addition, skeletal abnormalities including scoliosis are commonly seen in untreated Turner's syndrome, Noonan's syndrome, and Prader-Willi syndrome patients. Clinicians should be aware of these abnormalities, which may manifest during growth hormone therapy.

      Patients who have or at risk for pituitary hormone deficiencies, and are receiving somatropin, may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) adrenal insufficiency. Patients treated with glucocorticoid replacement for previously diagnosed adrenal insufficiency may require an increase in their maintenance or stress doses following initiation of somatropin treatment. In addition, patients with untreated hypothyroidism will have an inadequate response to somatropin therapy. Changes in thyroid hormone plasma levels may develop during somatropin therapy because patients with Turner's syndrome have an inherent risk of developing autoimmune thyroid disease. Periodic thyroid function tests should be performed and treatment with thyroid hormone initiated when indicated.[45045]

      Somatropin therapy has been reported to cause increased intracranial pressure with papilledema, visual changes, headache, and nausea and/or vomiting. Symptoms usually occurred within the first eight weeks of somatropin therapy. Resolution of intracranial hypertension-associated symptoms occurred after discontinuation of somatropin therapy or after a reduction in the hormone dose. Funduscopic examination is recommended at the initiation and periodically during the course of somatropin therapy. Patients with chronic renal insufficiency, Prader-Willi syndrome, and Turner's syndrome may be at increased risk for developing intracranial hypertension.

      No adequate and well controlled studies have been conducted in pregnant humans, and the potential for somatropin to cause adverse effects on the fetus or reproductive system is unknown. In animal studies that have been performed, differing doses exceeding the regular human dose revealed no evidence of impaired fertility or harm to the fetus. Inform females of childbearing age that use of somatropin during pregnancy has not been studied in humans, therefore, the effects of the drug on the fetus are unknown.[30059] [33527] [45044] [45045] [60682]

      No data are available regarding the presence of somatropin in human milk, the effects of somatropin on the breast-fed infant, or the effects of somatropin on milk production. Limited published literature reports no adverse effects on breast-feeding infants with maternal administration of somatropin and no decrease in milk production or change in milk content during treatment with somatropin. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.[30059] [33527] [45044] [45045] [60682]

      During treatment with somatropin, Turner's syndrome patients should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear or hearing disorders. In addition, patients with Turner's syndrome should be monitored closely for cardiovascular disorders such as stroke, aortic aneurysm, and hypertension because these patients are also at risk for these conditions.

      Clinical studies of somatropin did not include sufficient numbers of geriatric subjects. Reported clinical experience had not identified differences in responses between geriatric and younger adult patients. In general, dose selection for an older adult should be cautious, usually starting at the low end of the dosing range. Geriatric patients are more at risk for the adverse effects of therapy compared to pediatric and younger adult patients. According to practice guidelines, growth hormone/somatropin should only be prescribed to patients with clinical features suggestive of adult growth hormone deficiency (GHD) and biochemically proven evidence of adult GHD. There are no data available to suggest that somatropin has beneficial effects in treating aging and age-related conditions and the enhancement of sporting performance; therefore, the prescription of the drug to adult patients for any reason other than the well-defined approved uses of the drug is not recommended.[60946] According to the Beers Criteria, growth hormone is considered a potentially inappropriate medication (PIM) in geriatric patients. Avoid use in the older adult due to its small effect on body composition relative to a significant adverse effect profile (e.g., edema, arthralgia, carpal tunnel syndrome, gynecomastia, elevated fasting glucose). Use in patients rigorously diagnosed by evidence-based criteria with growth hormone deficiency due to an established etiology is acceptable.[63923]

      Somatropin (Serostim) has been used in patients with HIV-associated adipose redistribution syndrome (HARS); somatropin therapy may be less effective in females with HARS as compared to men. During clinical trials, 47 women receiving somatropin showed no difference from placebo with respect to reduction in visceral adipose tissue (VAT). Reasons for the lack of effectiveness may be the concomitant use of estrogen (6 patients) or a lower baseline VAT level as compared to men. Lower VAT levels have been demonstrated in several clinical trials to be associated with a reduced response to somatropin.

      Patients who develop persistent, severe abdominal pain during somatropin treatment should be evaluated for pancreatitis, especially pediatric patients. Use with caution in patients with a past history of pancreatitis or with risk factors for pancreatitis. Pancreatitis has been rarely reported in adults and children receiving somatropin, with pediatric patients appearing to be at greater risk compared to adults. Girls with Turner syndrome may have an even greater risk of developing pancreatitis compared to others undergoing somatropin treatment.[49770]

      Revision Date: 04/05/2024, 04:08:45 PM

      References

      30059 - Humatrope (somatropin) package insert. Indianapolis, IN: Eli Lilly and Company; 2023 Dec.33527 - Serostim (somatropin injection) package insert. Rockland, MA: EMD Serono, Inc.; 2019 June.45044 - Omnitrope (somatropin) package insert. Princeton, NJ: Sandoz, Inc.; 2016 Dec.45045 - Genotropin (somatropin) package insert. New York, NY: Pharmacia & Upjohn Company; 2016 Dec.45269 - Food and Drug Administration (US FDA) Drug Safety Communication. Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death. Retrieved August 4, 2011. Available on the WorldWide Web at: http://www.fda.gov/Drugs/DrugSafety/ucm265865.htm49770 - Nutropin (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56646 - Accretropin (somatropin) package insert. Winnipeg, Canada: Cangene Corporation; 2016 Dec.56647 - Nutropin AQ (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56649 - Saizen (somatropin) package insert. Rockland, MA: EMD Serono Inc; 2017 May.58095 - Norditropin (somatropin) package insert. Plainsboro, NJ: Novo Nordisk; 2017 Feb.59579 - Zomacton (somatropin) package insert. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2024 Apr.60682 - Zorbtive (somatropin) injection package insert. Rockland, MA: EMD Serono, Inc.; 2017 May.60946 - Cook DM, Yuen KC, Biller BM, et al; American Association of Clinical Endocrinologists (AACE). American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in growth hormone-deficient adults and transition patients - 2009 update: executive summary of recommendations. Endocr Pract. 2009;15:580-586.61679 - Albertsson-Wikland K, Martensson A, Savendalh L, et al. Mortality is not increased in recombinant human growth hormone-treated patients when adjusting for birth characteristics. J Clin Endocrinol Metab. 2016; 101: 2149-2159.63923 - The American Geriatrics Society 2019 Beers Criteria Update Expert Panel. American Geriatrics Society 2019 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2019;00:1-21.

      Mechanism of Action

      Endogenous growth hormone is responsible for stimulating normal skeletal, connective tissue, muscle, and organ growth in children and adolescents. It also plays an important role in adult metabolism. Recombinant products mimic all of these actions. Somatropin binds to growth hormone (GH) receptors and produces a variety of physiologic effects that can be classified as being direct or indirect. The direct effects include antagonism of the peripheral action of insulin and the subsequent stimulation of insulin secretion; stimulation of the production of somatomedins or insulin-like growth factors (IGFs) in the liver and other tissues; stimulation of triglyceride hydrolysis in adipose tissue; stimulation of hepatic glucose output; induction of a positive calcium balance; and retention of sodium and potassium. These effects oppose the action of insulin on fat and carbohydrate metabolism and are potentiated by glucocorticoids.[56647][57484]

       

      Somatomedins or insulin-like growth factors (IGFs) indirectly mediate the anabolic and growth-promoting effects of somatropin. IGFs circulate throughout the body and bind to specific IGF receptors. Two IGFs have been identified, IGF-1 and IGF-2. IGF-1 appears to be the principal mediator of the action of growth hormone, whereas IGF-2 has more insulin-like activity. The principal anabolic actions of IGFs include stimulation of amino acid transport, stimulation of DNA, RNA, and protein synthesis, and induction of cell proliferation and growth. IGF-1 is directly responsible for chondrogenesis, skeletal growth, and the growth of soft tissue. Linear growth is stimulated by affecting cartilaginous growth areas of long bones. Growth is also stimulated by increasing the number and size of skeletal muscle cells, influencing the size of organs, and increasing red cell mass through erythropoietin stimulation. The actions of growth hormone on the gut may be direct or mediated via the local or systemic production of IGF. In-vivo studies have shown that growth hormone enhances transmucosal transport of water, electrolytes, and nutrients. These indirect effects are inhibited by glucocorticoids.[57484]

      Revision Date: 04/05/2024, 04:08:45 PM

      References

      56647 - Nutropin AQ (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.57484 - Molina PE. Endocrine Physiology. New York, NY: McGraw-Hill Companies; 2013.

      Pharmacokinetics

      Somatropin is administered by intramuscular or subcutaneous injection. Peak plasma concentrations of somatropin are reached in 2—6 hours following administration. About 20% of the circulating somatropin is bound to growth hormone-binding protein. Peak plasma concentrations of IGF-1 occur about 20 hours after administration of somatropin. Somatropin is metabolized by the liver, kidney, and other tissues. Somatropin undergoes glomerular filtration and the molecule is cleaved in the kidney. Once cleavages occurs in the renal cells, the peptides and amino acids are returned to the systemic circulation. Little excretion occurs via the urine. The plasma elimination half-life is approximately 20—30 minutes. Because of continued release of somatropin from the intramuscular or subcutaneous site, serum concentrations decline with a half-life of about 3—5 hours. Because of the slow induction and clearance of IGF-1, the effects of somatropin last much longer than its elimination half-life.

      Route-Specific Pharmacokinetics

      Subcutaneous Route

      Following subcutaneous injection of the depot formulation, somatropin is released from the microspheres initially by diffusion, followed by both polymer degradation and diffusion. The estimated bioavailability following a single dose of Nutropin Depot ranges from 33—38% when compared to single dose Nutropin AQ and from 48—55% when compared to chronically dosed Protropin. Once released and absorbed, somatropin is believed to distributed and eliminated in a manner similar to somatropin formulated for daily administration. Both the Cmax and AUC are proportional to the dose. Serum growth hormone levels > 1 mcg/l persist for approximately 11—14 days following single doses of 0.75 or 1.5 mg/kg.

      Special Populations

      Pediatrics

      It appears that the clearance of somatropin in children and adults is similar; however, no pharmacokinetic studies have been conducted in children with short bowel syndrome.

      Gender Differences

      Biomedical literature indicates males may clear somatropin more quickly than females, although no gender-based analysis is available.

      Revision Date: 04/05/2024, 04:08:45 PM

      Pregnancy/Breast-feeding

      pregnancy

      No adequate and well controlled studies have been conducted in pregnant humans, and the potential for somatropin to cause adverse effects on the fetus or reproductive system is unknown. In animal studies that have been performed, differing doses exceeding the regular human dose revealed no evidence of impaired fertility or harm to the fetus. Inform females of childbearing age that use of somatropin during pregnancy has not been studied in humans, therefore, the effects of the drug on the fetus are unknown.[30059] [33527] [45044] [45045] [60682]

      breast-feeding

      No data are available regarding the presence of somatropin in human milk, the effects of somatropin on the breast-fed infant, or the effects of somatropin on milk production. Limited published literature reports no adverse effects on breast-feeding infants with maternal administration of somatropin and no decrease in milk production or change in milk content during treatment with somatropin. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.[30059] [33527] [45044] [45045] [60682]

      Revision Date: 04/05/2024, 04:08:45 PM

      References

      30059 - Humatrope (somatropin) package insert. Indianapolis, IN: Eli Lilly and Company; 2023 Dec.33527 - Serostim (somatropin injection) package insert. Rockland, MA: EMD Serono, Inc.; 2019 June.45044 - Omnitrope (somatropin) package insert. Princeton, NJ: Sandoz, Inc.; 2016 Dec.45045 - Genotropin (somatropin) package insert. New York, NY: Pharmacia & Upjohn Company; 2016 Dec.45269 - Food and Drug Administration (US FDA) Drug Safety Communication. Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death. Retrieved August 4, 2011. Available on the WorldWide Web at: http://www.fda.gov/Drugs/DrugSafety/ucm265865.htm60682 - Zorbtive (somatropin) injection package insert. Rockland, MA: EMD Serono, Inc.; 2017 May.61679 - Albertsson-Wikland K, Martensson A, Savendalh L, et al. Mortality is not increased in recombinant human growth hormone-treated patients when adjusting for birth characteristics. J Clin Endocrinol Metab. 2016; 101: 2149-2159.

      Interactions

      Level 2 (Major)

      • Macimorelin
      • Mecasermin, Recombinant, rh-IGF-1

      Level 3 (Moderate)

      • Acarbose
      • Albuterol; Budesonide
      • Alogliptin
      • Alogliptin; Metformin
      • Alogliptin; Pioglitazone
      • Antidiabetic Agents
      • Azelastine; Fluticasone
      • Beclomethasone
      • Betamethasone
      • Bexagliflozin
      • Budesonide
      • Budesonide; Formoterol
      • Budesonide; Glycopyrrolate; Formoterol
      • Canagliflozin
      • Canagliflozin; Metformin
      • Ciclesonide
      • Conjugated Estrogens
      • Conjugated Estrogens; Bazedoxifene
      • Conjugated Estrogens; Medroxyprogesterone
      • Corticosteroids
      • Cortisone
      • Cyclosporine
      • Dapagliflozin
      • Dapagliflozin; Metformin
      • Dapagliflozin; Saxagliptin
      • Deflazacort
      • Desogestrel; Ethinyl Estradiol
      • Dexamethasone
      • Dienogest; Estradiol valerate
      • Drospirenone; Estetrol
      • Drospirenone; Estradiol
      • Drospirenone; Ethinyl Estradiol
      • Drospirenone; Ethinyl Estradiol; Levomefolate
      • Dulaglutide
      • Elagolix; Estradiol; Norethindrone acetate
      • Empagliflozin
      • Empagliflozin; Linagliptin
      • Empagliflozin; Linagliptin; Metformin
      • Empagliflozin; Metformin
      • Ertugliflozin
      • Ertugliflozin; Metformin
      • Ertugliflozin; Sitagliptin
      • Esterified Estrogens
      • Esterified Estrogens; Methyltestosterone
      • Estradiol
      • Estradiol; Levonorgestrel
      • Estradiol; Norethindrone
      • Estradiol; Norgestimate
      • Estradiol; Progesterone
      • Estrogens
      • Estropipate
      • Ethinyl Estradiol; Norelgestromin
      • Ethinyl Estradiol; Norethindrone Acetate
      • Ethinyl Estradiol; Norgestrel
      • Ethynodiol Diacetate; Ethinyl Estradiol
      • Etonogestrel; Ethinyl Estradiol
      • Exenatide
      • Fludrocortisone
      • Flunisolide
      • Fluticasone
      • Fluticasone; Salmeterol
      • Fluticasone; Umeclidinium; Vilanterol
      • Fluticasone; Vilanterol
      • Formoterol; Mometasone
      • Glimepiride
      • Glipizide
      • Glipizide; Metformin
      • Glyburide
      • Glyburide; Metformin
      • Hydrocortisone
      • Insulin Aspart
      • Insulin Aspart; Insulin Aspart Protamine
      • Insulin Degludec; Liraglutide
      • Insulin Detemir
      • Insulin Glargine
      • Insulin Glargine; Lixisenatide
      • Insulin Glulisine
      • Insulin Lispro
      • Insulin Lispro; Insulin Lispro Protamine
      • Insulin, Inhaled
      • Isophane Insulin (NPH)
      • Levonorgestrel; Ethinyl Estradiol
      • Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate
      • Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate
      • Linagliptin
      • Linagliptin; Metformin
      • Liraglutide
      • Lixisenatide
      • Metformin
      • Metformin; Repaglinide
      • Metformin; Saxagliptin
      • Metformin; Sitagliptin
      • Methylprednisolone
      • Miglitol
      • Mometasone
      • Nateglinide
      • Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate
      • Norethindrone; Ethinyl Estradiol
      • Norethindrone; Ethinyl Estradiol; Ferrous fumarate
      • Norgestimate; Ethinyl Estradiol
      • Olopatadine; Mometasone
      • Pioglitazone
      • Pioglitazone; Glimepiride
      • Pioglitazone; Metformin
      • Pramlintide
      • Prednisolone
      • Prednisone
      • Regular Insulin
      • Regular Insulin; Isophane Insulin (NPH)
      • Relugolix; Estradiol; Norethindrone acetate
      • Repaglinide
      • Rosiglitazone
      • Saxagliptin
      • Segesterone Acetate; Ethinyl Estradiol
      • Semaglutide
      • Sitagliptin
      • Testosterone
      • Triamcinolone

      Level 4 (Minor)

      • Levothyroxine
      • Levothyroxine; Liothyronine (Porcine)
      • Levothyroxine; Liothyronine (Synthetic)
      • Liothyronine
      • Thyroid hormones
      Acarbose: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Albuterol; Budesonide: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Alogliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Alogliptin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Alogliptin; Pioglitazone: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Antidiabetic Agents: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Azelastine; Fluticasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Beclomethasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Betamethasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Bexagliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Budesonide: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Budesonide; Formoterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Budesonide; Glycopyrrolate; Formoterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Canagliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Canagliflozin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Ciclesonide: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Conjugated Estrogens: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Conjugated Estrogens; Bazedoxifene: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Conjugated Estrogens; Medroxyprogesterone: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Corticosteroids: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Cortisone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Cyclosporine: (Moderate) Somatropin may increase the activity of cytochrome-mediated metabolism of cyclosporine clearance. [6807] Dapagliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Dapagliflozin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Dapagliflozin; Saxagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Deflazacort: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Desogestrel; Ethinyl Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Dexamethasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Dienogest; Estradiol valerate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Drospirenone; Estetrol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Drospirenone; Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Drospirenone; Ethinyl Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Drospirenone; Ethinyl Estradiol; Levomefolate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Dulaglutide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Elagolix; Estradiol; Norethindrone acetate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Empagliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Empagliflozin; Linagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Empagliflozin; Linagliptin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Empagliflozin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Ertugliflozin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Ertugliflozin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Ertugliflozin; Sitagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Esterified Estrogens: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Esterified Estrogens; Methyltestosterone: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Estradiol; Levonorgestrel: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Estradiol; Norethindrone: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Estradiol; Norgestimate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Estradiol; Progesterone: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Estrogens: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Estropipate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Ethinyl Estradiol; Norelgestromin: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Ethinyl Estradiol; Norethindrone Acetate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Ethinyl Estradiol; Norgestrel: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Ethynodiol Diacetate; Ethinyl Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Etonogestrel; Ethinyl Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Exenatide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Fludrocortisone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Flunisolide: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Fluticasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Fluticasone; Salmeterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Fluticasone; Umeclidinium; Vilanterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Fluticasone; Vilanterol: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Formoterol; Mometasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Glimepiride: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Glipizide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Glipizide; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Glyburide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Glyburide; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Hydrocortisone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Insulin Aspart: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin Aspart; Insulin Aspart Protamine: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin Degludec; Liraglutide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin Detemir: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin Glargine: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin Glargine; Lixisenatide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin Glulisine: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin Lispro: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin Lispro; Insulin Lispro Protamine: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Insulin, Inhaled: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Isophane Insulin (NPH): (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Levonorgestrel; Ethinyl Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Levothyroxine: (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin. [43942] Levothyroxine; Liothyronine (Porcine): (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin. [43942] Levothyroxine; Liothyronine (Synthetic): (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin. [43942] Linagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Linagliptin; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Liothyronine: (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin. [43942] Liraglutide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Lixisenatide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Macimorelin: (Major) Avoid use of macimorelin with drugs that directly affect pituitary growth hormone secretion and may blunt the growth hormone response to macimorelin, such as somatropin (recombinant rhGH). Healthcare providers are advised to discontinue growth hormone therapy at least 1 week before administering macimorelin. Use of these medications together may impact the accuracy of the macimorelin growth hormone test. [62723] Mecasermin, Recombinant, rh-IGF-1: (Major) Use caution in concomitant use of mecasermin and somatropin. Both agents are used in the treatment of growth disorders and share feedback and pathway systems. Their additive use has not been studied. [8313] Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Metformin; Repaglinide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Metformin; Saxagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Metformin; Sitagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Methylprednisolone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Miglitol: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Mometasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Nateglinide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Norethindrone; Ethinyl Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Norgestimate; Ethinyl Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Olopatadine; Mometasone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Pioglitazone: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Pioglitazone; Glimepiride: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Pioglitazone; Metformin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Pramlintide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Prednisolone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Prednisone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807] Regular Insulin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Regular Insulin; Isophane Insulin (NPH): (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Relugolix; Estradiol; Norethindrone acetate: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Repaglinide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Rosiglitazone: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Saxagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Segesterone Acetate; Ethinyl Estradiol: (Moderate) Somatropin can induce the activity of cytochrome-mediated metabolism of antipyrine clearance. Because estrogens are also metabolized in this way, somatropin may alter the metabolism of estrogens. In addition, growth-hormone deficient women also treated with estrogen replacement therapy require substantially more somatropin therapy to obtain comparable effects when compared to women not taking estrogen. Patients should be monitored for changes in efficacy of either drug when somatropin and estrogens are coadministered. [6807] Semaglutide: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Sitagliptin: (Moderate) Patients with diabetes mellitus should be monitored closely during somatropin (recombinant rhGH) therapy. Antidiabetic drugs (e.g., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients. Growth hormones, such as somatropin, may decrease insulin sensitivity, leading to glucose intolerance and loss of blood glucose control. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus. [30059] [33527] [45044] [45045] [49770] [56647] [56648] [56649] [56650] [56651] [58095] [59579] [60682] Testosterone: (Moderate) Somatropin can induce (i.e., increase) the activity of cytochrome-mediated metabolism of antipyrine clearance in man. Thus, this predicts that somatropin may affect other drugs metabolized via this pathway, like testosterone. [30059] Thyroid hormones: (Minor) Excessive use of thyroid hormones with growth hormone (somatropin, rh-GH) may accelerate epiphyseal closure. However, untreated hypothyroidism may interfere with growth response to somatropin. Patients receiving concomitant therapy should be monitored closely to ensure appropriate therapeutic response to somatropin. [43942] Triamcinolone: (Moderate) Corticosteroids can retard bone growth and therefore, can inhibit the growth-promoting effects of somatropin. If corticosteroid therapy is required, the corticosteroid dose should be carefully adjusted. [6807]
      Revision Date: 04/05/2024, 04:08:45 PM

      References

      6807 - Humatrope (somatropin) package insert. Indianapolis, IN: Eli Lilly and Company; 2023 Dec.8313 - Bichell DP, Kikuchi K, Rotwein P. Growth hormone rapidly activates insulin-like growth factor I gene transcription in vivo. Mol Endocrinol 1992;6:1899-1908.30059 - Humatrope (somatropin) package insert. Indianapolis, IN: Eli Lilly and Company; 2023 Dec.33527 - Serostim (somatropin injection) package insert. Rockland, MA: EMD Serono, Inc.; 2019 June.43942 - Levothroid (levothyroxine sodium tablet) package insert. Shenandoah, IA: Lloyd Pharmaceutical; 2011 June.45044 - Omnitrope (somatropin) package insert. Princeton, NJ: Sandoz, Inc.; 2016 Dec.45045 - Genotropin (somatropin) package insert. New York, NY: Pharmacia & Upjohn Company; 2016 Dec.49770 - Nutropin (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56647 - Nutropin AQ (somatropin) package insert. San Francisco, CA: Genentech; 2016 Dec.56648 - Nutropin Depot (somatropin) package insert. San Francisco, CA: Genentech; 2004 Oct.56649 - Saizen (somatropin) package insert. Rockland, MA: EMD Serono Inc; 2017 May.56650 - Tev-Tropin (somatropin) package insert. Horsham, PA: Teva Select Brands; 2015 Feb.56651 - Valtropin (somatropin) package insert. Seoul, Korea: LG Life Sciences; 2007 Sept.58095 - Norditropin (somatropin) package insert. Plainsboro, NJ: Novo Nordisk; 2017 Feb.59579 - Zomacton (somatropin) package insert. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2024 Apr.60682 - Zorbtive (somatropin) injection package insert. Rockland, MA: EMD Serono, Inc.; 2017 May.62723 - Macrilen (macimorelin) package insert. Frankfurt am Main, Germany: Aeterna Zentaris GmbH; 2018 Jan.

      Monitoring Parameters

      • bone age determination
      • growth rate
      • ophthalmologic exam
      • serum growth hormone concentrations
      • thyroid function tests (TFTs)

      US Drug Names

      • Biotropin
      • Genotropin
      • Genotropin Intra-Mix
      • Genotropin MiniQuick
      • Humatrope
      • Norditropin
      • Norditropin FlexPro
      • Norditropin Nordiflex
      • Nutropin
      • Nutropin AQ
      • Nutropin AQ NuSpin
      • Nutropin Depot
      • Omnitrope
      • Saizen
      • Saizen Click.Easy Cartridge
      • Saizen Saizenprep Cartridge
      • Serostim
      • Serostim LQ
      • Tev-Tropin
      • ZOMACTON
      • Zorbtive
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