Elsevier Logo

ThisiscontentfromElsevier'sDrugInformation

TRANSFORM HOW YOU USE DRUG INFORMATION

Learn more about Elsevier's Drug Information today! Get the drug data and decision support you need, including TRUE Daily Updates™ including every day including weekends and holidays.

Feb.04.2021

Bamlanivimab

Indications/Dosage

Labeled

    Off-Label

    • coronavirus disease 2019 (COVID-19)
    • severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
    † Off-label indication

    INVESTIGATIONAL USE: For the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection† resulting in mild to moderate coronavirus disease 2019 (COVID-19)† in patients who are at high risk for progressing to severe COVID-19 or requiring hospitalization

    NOTE: Patients are deemed to be at high risk for progressing to severe COVID-19 or requiring hospitalization if they meet at least 1 of the following criteria:

    • Body mass index (BMI) greater than or equal to 35
    • Chronic kidney disease
    • Diabetes
    • Immunosuppressive disease or receiving immunosuppressive therapy
    • 65 years or older
    • 55 years or older AND have:
      • Cardiovascular disease OR
      • Hypertension OR
      • Chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
    • 12 to 17 years of age AND have:
      • BMI greater than or equal to 85th percentile for age and gender based on CDC growth charts OR
      • Sickle cell disease OR
      • Congenital or acquired heart disease OR
      • Neurodevelopmental disorder (e.g., cerebral palsy) OR
      • Medical-related technological dependency (e.g., tracheostomy, gastrostomy, positive pressure ventilation not related to COVID-19) OR
      • Asthma, restrictive airway, or other chronic respiratory disease that requires daily medication to control

    NOTE: Bamlanivimab is not authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy for COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 if already on chronic oxygen therapy for an underlying condition. Use of the drug in hospitalized patients with COVID-19 who require high flow oxygen or mechanism ventilation may be associated with worsening clinical outcomes.[66100]

    Intravenous dosage

    Adults weighing 40 kg or more

    700 mg via a single intravenous infusion. Administer the infusion as soon as possible after the positive test for SARS-CoV-2 and within 10 days of symptom onset.[66100]

    Children and Adolescents 12 years and older weighing 40 kg or more

    700 mg via a single intravenous infusion. Administer the infusion as soon as possible after the positive test for SARS-CoV-2 and within 10 days of symptom onset.[66100]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

    • Adults

      40 kg or more: 700 mg IV.

      less than 40 kg: Use not authorized.

    • Geriatric

      40 kg or more: 700 mg IV.

      less than 40 kg: Use not authorized.

    • Adolescents

      40 kg or more: 700 mg IV.

      less than 40 kg: Use not authorized.

    • Children

      12 years and weighing 40 kg or more: 700 mg IV.

      12 years and weighing less than 40 kg: Use not authorized.

      1 to 11 years: Use not authorized.

    • Infants

      Use not authorized.

    • Neonates

      Use not authorized.

    Patients with Hepatic Impairment Dosing

    No dosage adjustments are needed for patients with mild hepatic impairment. Treatment of patients with moderate to severe hepatic impairment has not been evaluated.

    Patients with Renal Impairment Dosing

    No dosage adjustments are needed.

    † Off-label indication
    Revision Date: 02/04/2021, 09:17:07 AM

    References

    66100 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/143603/download

    How Supplied

    Bamlanivimab Solution for injection

    Bamlanivimab 700mg/20mL Solution for Injection (00002-7910) (Eli Lilly and Co) nullBamlanivimab 700mg/20mL Solution for Injection package photo

    Description/Classification

    Description

    Bamlanivimab is an investigational neutralizing human immunoglobulin G-1 (IgG1) monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Bamlanivimab is not an FDA-approved medication; however, the drug has been authorized for use under an Emergency Use Authorization (EUA) to treat mild to moderate COVID-19 in patients (12 years and older weighing at least 40 kg) with positive SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 or hospitalization. The drug is NOT authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy for COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 if already on chronic oxygen therapy for an underlying condition. Use of the drug in hospitalized patients with COVID-19 who require high flow oxygen or mechanism ventilation may be associated with worsening clinical outcomes.[66100] The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend against the use of bamlanivimab as monotherapy because of limited clinical outcome data and concerns regarding decreased susceptibility in SARS-CoV-2 variants. Instead, for outpatients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by the EUA criteria, the NIH recommends using 1 of the combination anti-SARS-CoV-2 monoclonal antibodies (including bamlanivimab given in combination with etesevimab). However, if a combination product is not available, the use of bamlanivimab monotherapy can be considered on a case-by-case basis. The NIH emphasizes that anti-SARS-CoV-2 monoclonal antibodies should NOT be used to treat patients hospitalized due to COVID-19, except in a clinical trial; however, their use should be considered for high risk persons with mild to moderate COVID-19 who are hospitalized for a reason other than COVID-19. Anti-SARS-CoV-2 antibodies should be started as soon as possible after positive test results for SARS-CoV-2 and within 10 days of symptom onset. For patients who receive anti-SARS-CoV-2 antibodies, defer administration of the COVID-19 vaccination for at least 90 days as a precaution to avoid interference with vaccine-induced immune responses. Conversely, the use and timing of treatment with anti-SARS-CoV-2 antibodies should not be affected by prior vaccinations in patients who develop COVID-19 after receiving the vaccine.[65314] As of March 24th 2021, the U.S. Government and the manufacturer stopped the distribution of bamlanivimab alone (i.e., monotherapy) because of data showing sustained increase in SARS-CoV-2 viral variants within the United States that are resistant to bamlanivimab monotherapy. However, bamlanivimab is still available for order in combination with etesevimab (i.e., combination therapy). Additionally, health care providers may consider use of alternative monoclonal antibody therapies (i.e. casirivimab and imdevimab).[66549]

    Classifications

    • General Anti-infectives Systemic
      • Antivirals For Systemic Use
        • Antiviral Monoclonal Antibodies for SARS-CoV-2
    Revision Date: 04/09/2021, 11:23:17 AM

    References

    65314 - COVID-19 Treatment Guidelines Panel. Coronavirus Diseases 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Accessed April 8, 2021. Available at on the World Wide Web at: https://covid19treatmentguidelines.nih.gov/.66100 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/143603/download66549 - Office of the Assistant Secretary for Preparedness and Response. Update on COVID-19 variants and impact on bamlanivimab distribution. Department of Health and Human Services. March 24, 2021. Available at https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab/Pages/default.aspx. Accessed M

    Administration Information

    General Administration Information

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

     

    NOTE: Bamlanivimab is not an FDA-approved medication; however, the drug has been authorized for use under an Emergency Use Authorization (EUA) to treat mild to moderate COVID-19 in patients with positive SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 or hospitalization. Under the EUA, health care providers are required to communicate to the patient, parent, or caregiver information consistent with the "Fact Sheet for Patients, Parents and Caregivers" prior to the patient receiving treatment; such information includes the following:

    • The option to accept or refuse bamlanivimab
    • The significant known and potential risks and benefits of bamlanivimab, and the extent to which such potential risks and benefits are unknown
    • Available alternative treatments and the risk and benefits of those alternatives
    • The need to continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect, frequent hand washing) according to CDC guidelines

    NOTE: Under the EUA, health care providers are required to report all medication errors and serious adverse events potentially related to bamlanivimab therapy within 7 calendar days from the onset of the event.[66100]

    Route-Specific Administration

    Injectable Administration

    • Must be administered in a setting in which health care providers have immediate access to medications used to treat a severe infusion reaction and the ability to activate the emergency medical system, as necessary.
    • Visually inspect parenteral products for particulate matter and discoloration prior to drug administration. Bamlanivimab is a clear to opalescent and colorless to slightly yellow to slightly brown solution.[66100]

    Intravenous Administration

    Preparation and Dilution:

    • The infusion should be prepared and administered by a qualified health care professional using aseptic technique. The product does not contain a preservative.
    • Obtain required materials:
      • Polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC, sterile prefilled infusion bag. Choose 1 of the following sizes:
        • Prefilled 50 mL, 100 mL, 150 mL, or 250 mL infusion bag containing 0.9% Sodium Chloride Injection
      • One 20 mL bamlanivimab vial (700 mg/20 mL)
    • Remove 1 bamlanivimab vial from refrigerated storage and allow it to equilibrate to room temperature (approximately 20 minutes). DO NOT expose the vial to direct heat. DO NOT shake the vial.
    • Withdraw 20 mL of the bamlanivimab solution from the vial using an appropriately sized syringe. Discard any remaining product in the vial.
    • Transfer the 20 mL of bamlanivimab solution to the prefilled 0.9% Sodium Chloride Injection bag.
    • Gently invert the infusion bag by hand approximately 10 times to mix. DO NOT shake.
    • Storage: Use immediately after dilution. If immediate administration is not possible, the diluted solution may be stored at room temperature 20 to 25 degrees C (68 to 77 degrees F) for up to 7 hours or under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 24 hours (including infusion time). If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 20 minutes before administration.[66100]

     

    Intravenous Infusion:

    • Obtain a polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC infusion set. Use of an in-line or add-on 0.20/0.22 micron polyethersulfone (PES) filter is strongly recommended.
    • Attach the infusion set to the IV infusion bag.
    • Prime the infusion set.
    • Administer the entire infusion solution in the bag via pump or gravity. Due to potential overfill of prefilled saline bags, the entire infusion solution in the bag should be administered to avoid underdosage. The maximum infusion rate is 270 mL/hour; therefore, the infusion duration is dependent on the size of the infusion bag used:
      • 20 mL bamlanivimab added to a 50 mL prefilled 0.9% Sodium Chloride infusion bag (70 mL total) given over at least 16 minutes
      • 20 mL bamlanivimab added to a 100 mL prefilled 0.9% Sodium Chloride infusion bag (120 mL total) given over at least 27 minutes
      • 20 mL bamlanivimab added to a 150 mL prefilled 0.9% Sodium Chloride infusion bag (170 mL total) given over at least 38 minutes
      • 20 mL bamlanivimab added to a 250 mL prefilled 0.9% Sodium Chloride infusion bag (270 mL total) given over at least 60 minutes
    • The prepared infusion solution should not be administered simultaneously with other medications. The compatibility of bamlanivimab with solutions or medications other than 0.9% Sodium Chloride Injection is not known.
    • Once the infusion is complete, flush the infusion line with 0.9% Sodium Chloride to ensure delivery of the required dose.
    • Clinically monitor patients during the infusion and for at least 1 hour after the infusion is complete.
    • If the infusion must be discontinued due to an infusion reaction, discard any unused product.
    • The use of closed system transfer devices (CSTDs), elastomeric pumps, and pneumatic transport with bamlanivimab has not been studied.[66100]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database

    Bamlanivimab

      Revision Date: 02/04/2021, 09:19:59 AMCopyright 2004-2021 by Lawrence A. Trissel. All Rights Reserved.

      References

      66100 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/143603/download

      Adverse Reactions

      Mild

      • diarrhea
      • dizziness
      • flushing
      • headache
      • nausea
      • pruritus
      • vomiting

      Severe

      • anaphylactoid reactions
      • angioedema

      Moderate

      • infusion-related reactions

      Gastrointestinal adverse reactions that developed in patients treated with the recommended 700 mg dose of bamlanivimab during clinical trials included nausea (3%), diarrhea (1%), and vomiting (1%). The incidence of these reactions were similar to those observed in patients who received a placebo [nausea (4%), diarrhea (5%), vomiting (3%)] and those who received supratherapeutic doses (2,800 mg and 7,000 mg) of bamlanivimab [nausea (4% to 5%), diarrhea (2% to 7%), vomiting (1% to 3%)].[66100]

      Neurologic adverse reactions that developed in patients treated with the recommended 700 mg dose of bamlanivimab during clinical trials included dizziness (3%) and headache (3%). The incidence of these reactions were similar to those observed in patients who received a placebo [dizziness (2%), headache (2%)] and those who received supratherapeutic doses (2,800 mg and 7,000 mg) of bamlanivimab [dizziness (3%), headache (2%)].[66100]

      Pruritus was reported by 2% of patients treated with the recommended 700 mg dose of bamlanivimab during clinical trials. The incidence of pruritus was similar to those observed in patients who received a placebo (1%) and those who received supratherapeutic doses (2,800 mg and 7,000 mg) of bamlanivimab (3%).[66100]

      In ongoing, blinded trials, anaphylaxis or anaphylactoid reactions (n = 1) and other cases of serious infusion-related reactions have been reported during treatment with bamlanivimab. All cases required treatment, and all resolved. In the BLAZE-1 trial, immediate non-serious hypersensitivity events were noted in 2% of bamlanivimab recipients and 1% of patients who received a placebo. The reported events included pruritus, flushing, hypersensitivity, and 1 case of angioedema (facial swelling). All events resolved.[66100]

      Revision Date: 02/10/2021, 04:51:29 PM

      References

      66100 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/143603/download

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • breast-feeding
      • infusion-related reactions
      • pregnancy

      Clinical worsening of COVID-19 has been reported after bamlanivimab administration. Signs and symptoms have included fever, hypoxia or increased respiratory difficulty, arrythmia exacerbation (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events have required hospitalization. It is not known if these events were related to bamlanivimab treatment or were due to the progression of COVID-19. Additionally, monoclonal antibodies (such as bamlanivimab) may be associated with worsening clinical outcomes when administered to hospitalized patients with COVID-19 who require high flow oxygen or mechanism ventilation. Therefore, the drug is not authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy for COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 if already on chronic oxygen therapy for an underlying condition.[66100]

      Infusion-related reactions have been observed during treatment with bamlanivimab; these reactions may be severe or life-threatening. Signs and symptoms of these reactions include fever, chills, nausea, headache, bronchospasm, dyspnea, reduced oxygen saturation, fatigue, arrhythmia exacerbation (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, hypotension, hypertension, angioedema, throat irritation, rash, urticaria, pruritus, myalgia, dizziness, and diaphoresis. If an infusion-related reaction develops, consider slowing or stopping the infusion and administer appropriate medications and supportive care. Similarly, serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration of the drug and initiate appropriate medications and supportive care.[66100]

      There are insufficient data regarding the use of bamlanivimab during pregnancy to determine a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, bamlanivimab has the potential to be transferred from the mother to the developing fetus. It is unknown if this potential in utero transfer of bamlanivimab provides any therapeutic benefit or risk to the fetus. According to the manufacturer, bamlanivimab should be administered during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus.[66100] The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend that bamlanivimab not be withheld from a pregnant woman at risk of progressing to severe COVID-19 if the clinician thinks that the potential benefit outweighs potential risk.[65314]

      There are no data regarding the presence of bamlanivimab in human milk, the effects on the breast-fed infant, or the effects on milk production; however, maternal immunoglobulin G (IgG) is known to be present in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, the potential for viral transmission to SARS-CoV-2-negative infants, and the risk of an untreated or inadequately treated condition. Lactating mothers are advised to follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[66100]

      Revision Date: 02/04/2021, 11:31:12 AM

      References

      65314 - COVID-19 Treatment Guidelines Panel. Coronavirus Diseases 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Accessed April 8, 2021. Available at on the World Wide Web at: https://covid19treatmentguidelines.nih.gov/.66100 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/143603/download

      Mechanism of Action

      Bamlanivimab is a recombinant human immunoglobulin G-1 (IgG1) monoclonal antibody used as an antiviral medication to target the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). By binding to the spike protein, bamlanivimab blocks the attachment of SARS-CoV-2 to the human ACE2 receptor. Bamlanivimab is a neutralizing antibody that, when bound to the target cell expressing the spike protein, demonstrates antibody-dependent cell-mediated cytotoxicity. It does not elicit complement-dependent cytotoxicity activity. The estimated 50% effective concentration (EC50) against SARS-CoV-2 in Vero cells is 0.02 mcg/mL.[66100]

       

      Health care providers are advised to consider the prevalence of bamlanivimab resistant variants in their area when considering treatment options, as treatment failures are possible. Data from non-clinical studies have associated the following amino acid substitutions in the spike protein receptor binding domain with reduced susceptibility to bamlanivimab: E484D/K/Q, F490S, Q493R, and S494P. Additionally, an ongoing evaluation of viral variants observed through global surveillance has identified key spike protein substitutions associated with reduced susceptibility to bamlanivimab:

      • United Kingdom B.1.1.7 variant: N501Y (no change or less than 5-fold reduction in susceptibility)
      • South African B.1.351 variant: E484K (more than 2,360-fold reduced susceptibility)
      • Brazil P.1 variant: E484K (more than 2,360-fold reduced susceptibility)
      • California B.1.427/B.1.429 variant: L452R (more than 1,020-fold reduced susceptibility)
      • New York B.1.526 variant: E484K (more than 2,360-fold reduced susceptibility)
        • NOTE: Not all New York B.1.526 isolates harbored the E484K substitution

      Although it is still unknown if these data correlate with clinical outcomes, a reduction in susceptibility of more than 1,000-fold suggests that use of bamlanivimab alone is unlikely to be an effective treatment.[66100]

      Revision Date: 03/19/2021, 12:12:09 PM

      References

      66100 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/143603/download

      Pharmacokinetics

      Bamlanivimab is administered via intravenous infusion. Once in systemic circulation, the mean volume of distributions are 2.87 L for the central compartment and 2.71 L for the peripheral compartment. The drug is expected to be degraded into small peptides and component amino acids via catabolic pathways similarly to endogenous IgG antibodies. Clearance is 0.27 L/hour and the mean apparent terminal elimination half-life is 17.6 days.[66100]

       

      Affected cytochrome P450 isoenzymes: none

      Route-Specific Pharmacokinetics

      Intravenous Route

      Following a single intravenous infusion, the pharmacokinetic profile of bamlanivimab is linear and dose-proportional between the range of 700 mg and 7,000 mg. The mean maximum plasma concentration (Cmax) from a 700 mg bamlanivimab dose is 196 mcg/mL (90% CI: 102 to 378 mcg/mL). Bamlanivimab is quantifiable for at least 29 days post-dose, with a mean concentration of 22 mcg/mL (90% CI: 10.7 to 41.6 mcg/mL) on Day 29.[66100]

      Special Populations

      Hepatic Impairment

      Based on population pharmacokinetic analysis, there is no significant difference in the pharmacokinetics of bamlanivimab in patients with mild hepatic impairment as compared to patients with normal hepatic function. Bamlanivimab has not been studied in patients with moderate or severe hepatic impairment.[66100]

      Renal Impairment

      Bamlanivimab is not eliminated intact in the urine. The pharmacokinetics of bamlanivimab are not expected to be affected by renal function.[66100]

      Pediatrics

      The pharmacokinetics of bamlanivimab in pediatric patients have not been evaluated. Using modeling and simulation, the recommended dosing regimen is expected to result in plasma drug exposures (AUC) in pediatric patients 12 years and older weighing at least 40 kg that are comparable to those observed in adult patients.[66100]

      Geriatric

      Based on population pharmacokinetic analysis, age does not affect the pharmacokinetics of bamlanivimab.[66100]

      Gender Differences

      Based on population pharmacokinetic analysis, gender does not affect the pharmacokinetics of bamlanivimab.[66100]

      Ethnic Differences

      Based on population pharmacokinetic analysis, ethnicity does not affect the pharmacokinetics of bamlanivimab.[66100]

      Obesity

      Body weight has no clinically relevant effect on the pharmacokinetics of bamlanivimab in adults with COVID-19 who weigh between 41 kg to 173 kg.[66100]

      Other

      Disease Severity

      Based on population pharmacokinetic analysis, disease severity does not affect the pharmacokinetics of bamlanivimab. There have been no pharmacokinetic differences observed between hospitalized patients who are moderately to severely ill and ambulatory patients with mild to moderate disease.[66100]

      Revision Date: 12/21/2020, 09:52:16 AM

      References

      66100 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/143603/download

      Pregnancy/Breast-feeding

      pregnancy

      There are insufficient data regarding the use of bamlanivimab during pregnancy to determine a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, bamlanivimab has the potential to be transferred from the mother to the developing fetus. It is unknown if this potential in utero transfer of bamlanivimab provides any therapeutic benefit or risk to the fetus. According to the manufacturer, bamlanivimab should be administered during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus.[66100] The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend that bamlanivimab not be withheld from a pregnant woman at risk of progressing to severe COVID-19 if the clinician thinks that the potential benefit outweighs potential risk.[65314]

      breast-feeding

      There are no data regarding the presence of bamlanivimab in human milk, the effects on the breast-fed infant, or the effects on milk production; however, maternal immunoglobulin G (IgG) is known to be present in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, the potential for viral transmission to SARS-CoV-2-negative infants, and the risk of an untreated or inadequately treated condition. Lactating mothers are advised to follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[66100]

      Revision Date: 02/04/2021, 11:31:12 AM

      References

      65314 - COVID-19 Treatment Guidelines Panel. Coronavirus Diseases 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Accessed April 8, 2021. Available at on the World Wide Web at: https://covid19treatmentguidelines.nih.gov/.66100 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/143603/download

      Interactions

      There are no drug interactions associated with Bamlanivimab products.
      Revision Date: 11/11/2020, 02:38:00 AM

      References

      Monitoring Parameters

      • laboratory monitoring not necessary