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Feb.10.2021

Etesevimab

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: Etesevimab MUST be administered in combination with bamlanivimab. Use of etesevimab as a single agent is not authorized.

    NOTE: Etesevimab 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.[66394]

    Intravenous dosage

    Adults weighing 40 kg or more

    1,400 mg in combination with 700 mg of bamlanivimab administered together as 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.[66394]

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

    1,400 mg in combination with 700 mg of bamlanivimab administered together as 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.[66394]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

    • Adults

      40 kg or more: 1,400 mg IV.

      less than 40 kg: Use not authorized.

    • Geriatric

      40 kg or more: 1,400 mg IV.

      less than 40 kg: Use not authorized.

    • Adolescents

      40 kg or more: 1,400 mg IV.

      less than 40 kg: Use not authorized.

    • Children

      12 years and weighing 40 kg or more: 1,400 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: 02/10/2021, 04:18:12 PM

    References

    66394 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145802/download

    How Supplied

    Etesevimab Solution for injection

    Etesevimab 700mg/20mL Solution for Injection (00002-7950) (Eli Lilly and Co) null

    Description/Classification

    Description

    Etesevimab is an investigational human immunoglobulin G-1 (IgG1) monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is not an FDA-approved medication; however, the drug has been authorized by the FDA for emergency use in combination with another unapproved monoclonal antibody, bamlanivimab. Etesevimab, in combination with bamlanivimab, is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients (12 years and older weighing at least 40 kg) with positive SARS-CoV-2 viral testing, and 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.[66394] The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend using combination anti-SARS-CoV-2 monoclonal antibodies (including etesevimab plus bamlanivimab) to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression as defined by the Emergency Use Authorization (EUA) criteria. The NIH emphasizes that anti-SARS-CoV-2 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]

    Classifications

    • General Anti-infectives Systemic
      • Antivirals For Systemic Use
        • Antiviral Monoclonal Antibodies for SARS-CoV-2
    Revision Date: 04/09/2021, 11:25:01 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/.66394 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145802/download

    Administration Information

    General Administration Information

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

     

    NOTE: Etesevimab MUST be administered in combination with bamlanivimab. Use of etesevimab as a single agent is not authorized.

    NOTE: Etesevimab 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 etesevimab and bamlanivimab
    • The significant known and potential risks and benefits of etesevimab and 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 "high touch" surfaces, 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 etesevimab and bamlanivimab therapy within 7 calendar days from the onset of the event.[66394]

    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. Both etesevimab and bamlanivimab are clear to opalescent and colorless to slightly yellow to slightly brown solutions.[66394]

    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) and two 20 mL etesevimab vials (700 mg/20 mL)
    • Remove 1 bamlanivimab vial and 2 etesevimab vials from refrigerated storage and allow them to equilibrate to room temperature (approximately 20 minutes). DO NOT expose the vials to direct heat. DO NOT shake the vials.
    • Withdraw 20 mL from 1 bamlanivimab vial and 40 mL from 2 etesevimab vials and inject all 60 mL into the prefilled infusion bag containing 0.9% Sodium Chloride Injection. Discard any remaining product in the vials.
    • 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.

     

    Intravenous Infusion:

    • Obtain a polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC infusion set. Use of an in-line or add-on 0.2/0.22 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 minimum infusion duration is dependent on the size of the infusion bag used.
      • Patients weighing 40 to 49 kg:
        • 20 mL bamlanivimab and 40 mL etesevimab added to a 50 mL prefilled 0.9% Sodium Chloride infusion bag (110 mL total) given over at least 21 minutes
        • 20 mL bamlanivimab and 40 mL etesevimab added to a 100 mL prefilled 0.9% Sodium Chloride infusion bag (160 mL total) given over at least 31 minutes
        • 20 mL bamlanivimab and 40 mL etesevimab added to a 150 mL prefilled 0.9% Sodium Chloride infusion bag (210 mL total) given over at least 41 minutes
        • 20 mL bamlanivimab and 40 mL etesevimab added to a 250 mL prefilled 0.9% Sodium Chloride infusion bag (310 mL total) given over at least 70 minutes
      • Patients weighing 50 kg or more:
        • 20 mL bamlanivimab and 40 mL etesevimab added to a 50 mL prefilled 0.9% Sodium Chloride infusion bag (110 mL total) given over at least 21 minutes
        • 20 mL bamlanivimab and 40 mL etesevimab added to a 100 mL prefilled 0.9% Sodium Chloride infusion bag (160 mL total) given over at least 31 minutes
        • 20 mL bamlanivimab and 40 mL etesevimab added to a 150 mL prefilled 0.9% Sodium Chloride infusion bag (210 mL total) given over at least 41 minutes
        • 20 mL bamlanivimab and 40 mL etesevimab added to a 250 mL prefilled 0.9% Sodium Chloride infusion bag (310 mL total) given over at least 60 minutes
    • The prepared infusion solution should not be administered simultaneously with other medications. The compatibility of etesevimab and 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 has not been studied.[66394]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database

    Etesevimab

      Revision Date: 02/10/2021, 04:57:01 PMCopyright 2004-2021 by Lawrence A. Trissel. All Rights Reserved.

      References

      66394 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145802/download

      Adverse Reactions

      Mild

      • dizziness
      • fever
      • flushing
      • nausea
      • pruritus
      • rash

      Severe

      • anaphylactoid reactions
      • angioedema

      Moderate

      • infusion-related reactions

      Adverse reactions that developed in patients treated with a supratherapeutic dose of etesevimab (2,800 mg) in combination with bamlanivimab (2,800 mg) during clinical trials included nausea (1% to 4%), pruritus (2%), fever (1%), dizziness (1%), and rash (1%).[66394]

      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 with and without etesevimab. All cases required treatment, and all resolved. In the phase 2 portion of the BLAZE-1 trial, immediate hypersensitivity events were noted in 2% of patients treated with bamlanivimab and etesevimab. The reported events included pruritus, flushing, hypersensitivity, and 1 case of angioedema (facial swelling). In the phase 3 portion of the BLAZE-1 trial, 1% of patients treated with bamlanivimab and etesevimab experienced immediate hypersensitivity events. These events including infusion-related reactions (n = 2), rash (n = 2), infusion site rash (n = 1), and pruritus (n = 1). All events resolved.[66394]

      Revision Date: 02/10/2021, 04:41:36 PM

      References

      66394 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145802/download

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • breast-feeding
      • infusion-related reactions
      • pregnancy

      Etesevimab MUST be administered in combination with bamlanivimab; clinical worsening of COVID-19 has been reported after bamlanivimab administration. Signs and symptoms 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 etesevimab and 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, these drugs are 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][66394]

      Infusion-related reactions have been observed during treatment with etesevimab plus 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 with and without etesevimab. 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.[66394]

      There are insufficient data regarding the use of etesevimab or 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, these drugs have the potential to be transferred from the mother to the developing fetus. It is unknown if this potential in utero transfer provides any therapeutic benefit or risk to the fetus. According to the manufacturer, etesevimab plus bamlanivimab should be administered during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus.[66394] The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend that etesevimab plus 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 etesevimab or 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 clinical guideline recommendations to avoid exposing the infant to COVID-19. If a breast-fed infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[66394]

      Revision Date: 02/24/2021, 10:05:54 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/download66394 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145802/download

      Mechanism of Action

      Etesevimab is a recombinant human immunoglobulin G-1 (IgG1) monoclonal antibody used in combination with another IgG1 monoclonal antibody (bamlanivimab) to treat infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Both etesevimab and bamlanivimab target the spike protein of SARS-CoV-2; however, they bind to different but overlapping epitopes in the receptor binding domain (RBD) of the S-protein. By binding to the spike protein, these monoclonal antibodies block the attachment of SARS-CoV-2 to the human ACE2 receptor. Both etesevimab and bamlanivimab are neutralizing antibodies. Bamlanivimab demonstrates antibody-dependent cell-mediated cytotoxicity, but does not elicit complement-dependent cytotoxicity activity. Etesevimab does not demonstrate detectable antibody-dependent cell-mediated cytotoxicity or elicit complement-dependent cytotoxicity. The estimated 50% effective concentration (EC50) against SARS-CoV-2 in Vero cells of bamlanivimab, etesevimab, and a 1:1 ratio of bamlanivimab and etesevimab is 0.02 mcg/mL, 0.14 mcg/mL, and 0.02 mcg/mL, respectively.[66394]

       

      There is a potential for treatment failure due to the development of viral variants that are resistant to both etesevimab and bamlanivimab; however, the use of these antibodies together is expected to reduce the risk of viral resistance. Health care providers are advised to consider the prevalence of SARS-CoV-2 variants in their area when considering treatment options. Data from non-clinical studies have associated E484D/K/Q, F490S, Q493R, and S494P amino acid substitutions in the spike protein with reduced susceptibility to bamlanivimab. Viral variants with reduced susceptibility to etesevimab include substitutions K417N, D420N, and N460K/S/T. All variants maintained susceptibility to bamlanivimab and etesevimab together, except for those with E484K, E484Q, and Q493R substitutions, which had reduced susceptibilities of 17-fold, 22-fold, and more than 100-fold, respectively. An evaluation of susceptibility data from SARS-CoV-2 variants identified through global surveillance in patients treated with etesevimab and bamlanivimab is ongoing. As of February 2021, data for variant substitutions with etesevimab and bamlanivimab together show:

      • United Kingdom B.1.1.7 variant: N501Y (no change or less than 5-fold reduction in susceptibility)
      • South Africa B.1.351 variant: K417N + E484K + N501Y (more than 45-fold reduced susceptibility)
      • Brazil P.1 variant: K417T + E484K + N501Y (more than 511-fold reduced susceptibility)
      • California B.1.427/B.1.429 variant: L452R (7.4-fold reduced susceptibility)
      • New York B.1.526 variant: E484K (17-fold reduced susceptibility)
        • NOTE: Not all New York B.1.526 isolates harbored the E484K substitution

      Although it is still unknown how these data correlate with clinical outcomes, it is unlikely etesevimab and bamlanivimab together will be active against South Africa B.1.351 or Brazil P.1 variants.[66394]

      Revision Date: 03/19/2021, 02:25:41 PM

      References

      66394 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145802/download

      Pharmacokinetics

      Etesevimab is administered in combination with bamlanivimab via a single intravenous infusion; there are no changes in the pharmacokinetics of either etesevimab or bamlanivimab when administered alone or together. Once in systemic circulation, the mean volume of distributions for etesevimab are 2.38 L for the central compartment and 1.98 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 0.128 L/hour and the mean apparent terminal elimination half-life is 25.1 days.[66394]

       

      Affected cytochrome P450 isoenzymes: none

      Route-Specific Pharmacokinetics

      Intravenous Route

      Following a single intravenous infusion, the pharmacokinetic profile of etesevimab is linear and dose-proportional between the range of 700 mg and 7,000 mg. The mean maximum plasma concentration (Cmax) from a 1,400 mg etesevimab dose is 504 mcg/mL (90% CI: 262 to 974 mcg/mL). Etesevimab is quantifiable for at least 29 days post-dose, with a mean concentration of 111 mcg/mL (90% CI: 57.4 to 199 mcg/mL) on Day 29.[66394]

      Special Populations

      Hepatic Impairment

      Based on population pharmacokinetic analysis, there is no difference in the pharmacokinetics of etesevimab in patients with mild hepatic impairment as compared to patients with normal hepatic function. Etesevimab has not been studied in patients with moderate or severe hepatic impairment.[66394]

      Renal Impairment

      Etesevimab is not eliminated intact in the urine. The pharmacokinetics of etesevimab are not expected to be affected by renal function or the presence of dialysis.[66394]

      Pediatrics

      The pharmacokinetics of etesevimab in pediatric patients have not been evaluated. Using pharmacokinetic 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.[66394]

      Geriatric

      Based on population pharmacokinetic analysis, there is no difference in the pharmacokinetics of etesevimab in geriatric patients as compared to younger patients.[66394]

      Gender Differences

      Based on population pharmacokinetic analysis, gender does not affect the pharmacokinetics of etesevimab.[66394]

      Ethnic Differences

      Based on population pharmacokinetic analysis, ethnicity does not affect the pharmacokinetics of etesevimab.[66394]

      Obesity

      Body weight has no clinically relevant effect on the pharmacokinetics of etesevimab in adults with COVID-19 who weigh between 41 kg to 173 kg.[66394]

      Other

      Disease Severity

      Based on population pharmacokinetic analysis, disease severity does not affect the pharmacokinetics of etesevimab. There were no differences in the pharmacokinetics of etesevimab between mild to moderate ambulatory patients and healthy subjects.[66394]

      Revision Date: 02/10/2021, 05:13:23 PM

      References

      66394 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145802/download

      Pregnancy/Breast-feeding

      pregnancy

      There are insufficient data regarding the use of etesevimab or 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, these drugs have the potential to be transferred from the mother to the developing fetus. It is unknown if this potential in utero transfer provides any therapeutic benefit or risk to the fetus. According to the manufacturer, etesevimab plus bamlanivimab should be administered during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus.[66394] The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend that etesevimab plus 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 etesevimab or 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 clinical guideline recommendations to avoid exposing the infant to COVID-19. If a breast-fed infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[66394]

      Revision Date: 02/24/2021, 10:05:54 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/download66394 - Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145802/download

      Interactions

      There are no drug interactions associated with Etesevimab products.
      Revision Date: 02/24/2021, 02:37:00 AM

      References

      Monitoring Parameters

      • laboratory monitoring not necessary