Miscellaneous antivirals
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Bamlanivimab Dosage

Drug Detail:Bamlanivimab (Bamlanivimab [ bam-la-niv-i-mab ])

Drug Class: Miscellaneous antivirals

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Usual Adult Dose for COVID-19

For investigational use only

Bamlanivimab 700 mg and etesevimab 1400 mg administered together as a single IV infusion

Comments:

  • The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of the unapproved drugs bamlanivimab and etesevimab administered together for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death; this regimen is not approved by the US FDA for this use.
  • January 24, 2022: Due to the high frequency of the Omicron variant, this regimen is not currently authorized in any US region; therefore, this regimen may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.
  • Limitations of Authorized Use:
  • This regimen is not authorized for treatment of mild to moderate COVID-19 in geographic regions where infection is likely due to nonsusceptible SARS-CoV-2 variant based on available information such as variant susceptibility to this regimen and regional variant frequency.
  • This regimen is not authorized for use in patients who are hospitalized due to COVID-19.
  • This regimen is not authorized for use in patients who: require oxygen therapy and/or respiratory support due to COVID-19, OR require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.
  • Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19; monoclonal antibodies (such as these drugs) may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation.
  • Bamlanivimab and etesevimab should be administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.
  • No dose adjustment recommended in elderly patients or in pregnant or lactating patients.
  • For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: With etesevimab, for the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death

Usual Adult Dose for Postexposure Prophylaxis

For investigational use only

Bamlanivimab 700 mg and etesevimab 1400 mg administered together as a single IV infusion

Comments:

  • The US FDA issued an EUA to allow the emergency use of the unapproved drugs bamlanivimab and etesevimab administered together for postexposure prophylaxis of COVID-19 in patients who are at high risk for progression to severe COVID-19, including hospitalization or death, and are: not fully vaccinated OR who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination AND have been exposed to someone infected with SARS-CoV-2 consistent with close contact criteria per US CDC OR who are at high risk of exposure to someone infected with SARS-CoV-2 due to occurrence of SARS-CoV-2 infection in others in the same institutional setting; this regimen is not approved by the US FDA for this use.
  • January 24, 2022: Due to the high frequency of the Omicron variant, this regimen is not currently authorized in any US region; therefore, this regimen may not be administered for postexposure prevention of COVID-19 under the EUA until further notice by the US FDA.
  • Limitations of Authorized Use:
  • This regimen is not authorized for postexposure prophylaxis of COVID-19 in geographic regions where exposure is likely to have been to a nonsusceptible SARS-CoV-2 variant, based on available information including variant susceptibility to this regimen and regional variant frequency.
  • Postexposure prophylaxis with this regimen is not a substitute for vaccination against COVID-19.
  • This regimen is not authorized for preexposure prophylaxis for prevention of COVID-19.
  • Bamlanivimab and etesevimab should be administered together as soon as possible after exposure to SARS-CoV-2.
  • No dose adjustment recommended in pregnant or lactating patients.
  • Patients are considered fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series, or 2 weeks after a single-dose vaccine. For additional information: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html#vaccinated
  • For additional information regarding patients with immunocompromising conditions: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html
  • Close contact with an infected individual is defined as: being within 6 feet for at least 15 minutes (total), providing care at home to someone who is sick, having direct physical contact with the person (e.g., hugging, kissing), sharing eating/drinking utensils, or being exposed to respiratory droplets from an infected person (e.g., sneezing, coughing). For additional information: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html
  • For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: With etesevimab, for the postexposure prophylaxis of COVID-19 in patients who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
  • not fully vaccinated OR who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (e.g., patients with immunocompromising conditions including those taking immunosuppressive agents) AND
  • have been exposed to someone infected with SARS-CoV-2 consistent with close contact criteria per US CDC OR
  • who are at high risk of exposure to someone infected with SARS-CoV-2 due to occurrence of SARS-CoV-2 infection in others in the same institutional setting (e.g., nursing homes, prisons)

Usual Pediatric Dose for COVID-19

For investigational use only

Younger than 18 years:

  • Weight 1 to 12 kg: Bamlanivimab 12 mg/kg and etesevimab 24 mg/kg administered together as a single IV infusion
  • Weight greater than 12 to 20 kg: Bamlanivimab 175 mg and etesevimab 350 mg administered together as a single IV infusion
  • Weight greater than 20 to less than 40 kg: Bamlanivimab 350 mg and etesevimab 700 mg administered together as a single IV infusion
  • Weight at least 40 kg: Bamlanivimab 700 mg and etesevimab 1400 mg administered together as a single IV infusion

Comments:
  • The US FDA issued an EUA to allow the emergency use of the unapproved drugs bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death; this regimen is not approved by the US FDA for this use.
  • January 24, 2022: Due to the high frequency of the Omicron variant, this regimen is not currently authorized in any US region; therefore, this regimen may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.
  • Limitations of Authorized Use:
  • This regimen is not authorized for treatment of mild to moderate COVID-19 in geographic regions where infection is likely due to nonsusceptible SARS-CoV-2 variant based on available information such as variant susceptibility to this regimen and regional variant frequency.
  • This regimen is not authorized for use in patients 2 years or older who are hospitalized due to COVID-19. Compared to older children and adults, there may be different reasons and lower threshold for hospital admission for neonates, young infants, and toddlers with COVID-19; the authorization allows for young children (i.e., birth to 2 years of age) who are hospitalized with mild to moderate COVID-19 at time of treatment to receive this regimen.
  • This regimen is not authorized for use in patients, regardless of age, who: require oxygen therapy and/or respiratory support due to COVID-19, OR require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.
  • Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19; monoclonal antibodies (such as these drugs) may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation.
  • The recommended dosing regimen for patients weighing up to 12 kg is predicted based on pharmacokinetic modeling and simulation; the youngest subject in the pediatric clinical trial for treatment was 10 months of age and weighed 8.6 kg.
  • Bamlanivimab and etesevimab should be administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.
  • No dose adjustment recommended in pregnant or lactating patients.
  • For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: With etesevimab, for the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death

Usual Pediatric Dose for Postexposure Prophylaxis

For investigational use only

Younger than 18 years:

  • Weight 1 to 12 kg: Bamlanivimab 12 mg/kg and etesevimab 24 mg/kg administered together as a single IV infusion
  • Weight greater than 12 to 20 kg: Bamlanivimab 175 mg and etesevimab 350 mg administered together as a single IV infusion
  • Weight greater than 20 to less than 40 kg: Bamlanivimab 350 mg and etesevimab 700 mg administered together as a single IV infusion
  • Weight at least 40 kg: Bamlanivimab 700 mg and etesevimab 1400 mg administered together as a single IV infusion

Comments:
  • The US FDA issued an EUA to allow the emergency use of the unapproved drugs bamlanivimab and etesevimab administered together for postexposure prophylaxis of COVID-19 in patients who are at high risk for progression to severe COVID-19, including hospitalization or death, and are: not fully vaccinated OR who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination AND have been exposed to someone infected with SARS-CoV-2 consistent with close contact criteria per US CDC OR who are at high risk of exposure to someone infected with SARS-CoV-2 due to occurrence of SARS-CoV-2 infection in others in the same institutional setting; this regimen is not approved by the US FDA for this use.
  • January 24, 2022: Due to the high frequency of the Omicron variant, this regimen is not currently authorized in any US region; therefore, this regimen may not be administered for postexposure prevention of COVID-19 under the EUA until further notice by the US FDA.
  • Limitations of Authorized Use:
  • This regimen is not authorized for postexposure prophylaxis of COVID-19 in geographic regions where exposure is likely to have been to a nonsusceptible SARS-CoV-2 variant, based on available information including variant susceptibility to this regimen and regional variant frequency.
  • Postexposure prophylaxis with this regimen is not a substitute for vaccination against COVID-19.
  • This regimen is not authorized for preexposure prophylaxis for prevention of COVID-19.
  • The recommended dosing regimen for patients weighing up to 12 kg is predicted based on pharmacokinetic modeling and simulation; the youngest subject in the pediatric clinical trial for treatment was 10 months of age and weighed 8.6 kg. Children were not enrolled in the postexposure prophylaxis trial.
  • Bamlanivimab and etesevimab should be administered together as soon as possible after exposure to SARS-CoV-2.
  • No dose adjustment recommended in pregnant or lactating patients.
  • Patients are considered fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series, or 2 weeks after a single-dose vaccine. For additional information: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html#vaccinated
  • For additional information regarding patients with immunocompromising conditions: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html
  • Close contact with an infected individual is defined as: being within 6 feet for at least 15 minutes (total), providing care at home to someone who is sick, having direct physical contact with the person (e.g., hugging, kissing), sharing eating/drinking utensils, or being exposed to respiratory droplets from an infected person (e.g., sneezing, coughing). For additional information: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html
  • For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: With etesevimab, for the postexposure prophylaxis of COVID-19 in patients who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
  • not fully vaccinated OR who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (e.g., patients with immunocompromising conditions including those taking immunosuppressive agents) AND
  • have been exposed to someone infected with SARS-CoV-2 consistent with close contact criteria per US CDC OR
  • who are at high risk of exposure to someone infected with SARS-CoV-2 due to occurrence of SARS-CoV-2 infection in others in the same institutional setting

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Mild liver dysfunction: No adjustment recommended.
Moderate or severe liver dysfunction: Data not available

Precautions

US BOXED WARNINGS:

  • Treatment: This EUA is for the use of the unapproved drugs bamlanivimab and etesevimab to be administered together to treat mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death; bamlanivimab and etesevimab should be administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.
  • Postexposure Prophylaxis: This EUA is for the use of the unapproved drugs bamlanivimab and etesevimab administered together for postexposure prophylaxis of COVID-19 in patients who are at high risk for progression to severe COVID-19, including hospitalization or death, and are: not fully vaccinated OR who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination AND have been exposed to someone infected with SARS-CoV-2 consistent with close contact criteria per US CDC OR who are at high risk of exposure to someone infected with SARS-CoV-2 due to occurrence of SARS-CoV-2 infection in others in the same institutional setting; bamlanivimab and etesevimab should be administered together as soon as possible after exposure to SARS-CoV-2.
  • Under this EUA, bamlanivimab and etesevimab must be administered together by IV infusion only; they may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction (e.g., anaphylaxis) and the ability to activate the emergency medical system, as needed.
  • Health care providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS potentially related to this regimen; the Fact Sheet for Health Care Providers should be consulted regarding reporting requirements.
  • The authorized dosage may be updated as additional clinical trial data become available.
  • ClinicalTrials.gov should be consulted for information on clinical trials testing this regimen in COVID-19.

CONTRAINDICATIONS: None

Bamlanivimab and etesevimab are not authorized for use in pediatric patients weighing less than 40 kg or those younger than 12 years.

Dialysis

Data not available

Other Comments

January 24, 2022: Due to the high frequency of the Omicron variant, this regimen is not currently authorized in any US region; therefore, this regimen may not be administered for treatment or postexposure prevention of COVID-19 under the EUA until further notice by the US FDA.

Administration advice:

  • Bamlanivimab and etesevimab infusion solution should be administered by a qualified health care professional.
  • Administer bamlanivimab and etesevimab (which are supplied in individual vials) together as a single IV infusion.
  • Do not administer the prepared infusion solution simultaneously with any other medication.
  • Once infusion is complete, flush the tubing or extension set with 0.9% Sodium Chloride to ensure the required dose has been delivered.
  • If the infusion must be stopped due to an infusion reaction, discard any unused product.
  • The use of closed system transfer devices (CSTDs), elastomeric pumps, and pneumatic transport with bamlanivimab and etesevimab has not been studied.
  • Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.
IV INFUSION IN ADULTS (AT LEAST 18 YEARS REGARDLESS OF WEIGHT) AND PEDIATRIC PATIENTS (YOUNGER THAN 18 YEARS AND WEIGHING AT LEAST 40 kg):
  • Administer the entire infusion solution in the bag via pump or gravity (infusion time according to the size of infusion bag used).
  • Use a polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC, sterile prefilled infusion bag containing 0.9% Sodium Chloride Injection (sizes 50 to 250 mL) and a PVC or PE-lined PVC infusion set; use of in-line or add-on 0.2/0.22 micron polyethersulfone (PES) filter is strongly recommended.
  • Minimum infusion time per size of prefilled 0.9% Sodium Chloride infusion bag: 21 minutes for 50 mL infusion bag (maximum infusion rate: 310 mL/hour); 31 minutes for 100 mL infusion bag (maximum infusion rate: 310 mL/hour); 41 minutes for 150 mL infusion bag (maximum infusion rate: 310 mL/hour); 60 minutes for 250 mL infusion bag in patients weighing at least 50 kg (maximum infusion rate: 310 mL/hour); extend to 70 minutes for 250 mL infusion bag in patients weighing 40 to less than 50 kg to reduce endotoxin load (maximum infusion rate: 266 mL/hour)
  • Due to potential overfill of prefilled saline bags, administer the entire infusion solution in the bag to avoid underdosage.
IV INFUSION IN PEDIATRIC PATIENTS (YOUNGER THAN 18 YEARS AND WEIGHING LESS THAN 40 kg):
  • Pediatric doses do not need to be diluted for patients weighing less than 40 kg.
  • Administer the entire infusion solution in the bag (via pump or gravity) or the entire contents of the syringe (via syringe pump) over at least 16 minutes; consult the Fact Sheet for Health Care Providers for maximum infusion rate per weight range.
  • IV Bag: Use a sterile, empty 50-mL PVC or PE-lined PVC infusion bag and a PVC or PE-lined PVC infusion set; use of in-line or add-on 0.2/0.22 micron PES filter is strongly recommended.
  • Syringe Pump: Use a disposable syringe, a syringe extension set, and a syringe pump.

Storage requirements:
  • Unopened vials: Store in refrigerator at 2C to 8C (36F to 46F) in original carton to protect from light; do not freeze, shake, or expose to direct light.
  • Remove vials from refrigerated storage and allow to equilibrate to room temperature for about 20 minutes before preparation; do not expose to direct heat; do not shake the vials.
  • Prepared infusion solution: Should administer immediately; if immediate administration is not possible, store for up to 24 hours in refrigerator at 2C to 8C (36F to 46F) and up to 7 hours at room temperature (20C to 25C [68F to 77F]), including infusion time. If refrigerated, allow to equilibrate to room temperature for about 20 minutes prior to administration.

Reconstitution/preparation techniques:
  • Bamlanivimab and etesevimab solution for infusion should be prepared by a qualified health care professional.
  • Bamlanivimab and etesevimab are both available as solutions in separate vials and must be combined prior to administration.
  • The Fact Sheet for Health Care Providers should be consulted.

IV compatibility:
  • Compatible: 0.9% Sodium Chloride Injection
  • Compatibility with other IV solutions and medications is not known.

General:
  • April 16, 2021: The US FDA has revoked the EUA to allow the emergency use of bamlanivimab alone for the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 and/or hospitalization.
  • The US FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and US CDC regional variant frequency data (https://covid.cdc.gov/covid-data-tracker/#variant-proportions).
  • Repeat dosing of bamlanivimab and etesevimab has not been evaluated.
  • Criteria for Identifying High-Risk Patients: The following medical conditions or other factors may place adults and pediatric patients (including neonates) at higher risk for progression to severe COVID-19:
  • Older age (e.g., at least 65 years of age)
  • Younger than 1 year
  • Obesity or being overweight
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive therapy
  • Cardiovascular disease (including congenital heart disease) or hypertension
  • Chronic lung diseases (e.g., chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, pulmonary hypertension)
  • Sickle cell disease
  • Neurodevelopmental disorders (e.g., cerebral palsy) or other conditions that confer medical complexity (e.g., genetic/metabolic syndromes, severe congenital anomalies)
  • Having a medical-related technological dependence (e.g., tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID-19])
  • Other medical conditions or factors (e.g., race, ethnicity) may also place individual patients at high risk for progressing to severe COVID-19 and authorization of this regimen under the EUA is not limited to the medical conditions or factors listed above; the US CDC website (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html) should be consulted for additional information. The benefit-risk should be considered for each patient.
  • The Fact Sheet for Health Care Providers should be consulted regarding approved available alternatives.

Patient advice:
  • Read the Fact Sheet for Patients, Parents, and Caregivers.
  • 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 handwashing) according to US CDC guidelines.
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