Dosing & Uses
AdultPediatric
Dosage Forms & Strengths
IV solution
- Distributed as individual vials
- Bamlanivimab: 700mg/20mL (35mg/mL)
- Etesevimab: 700mg/20mL (35mg/mL)
COVID-19 (EUA)
Distribution paused
- January 24, 2022: Owing to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any United States region
- In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions
Treatment
- Emergency use authorization (EUA) issued by the FDA for 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, and who are at high risk for progressing to severe COVID-19, including hospitalization or death
- Administer bamlanivimab and etesevimab only in combination; monotherapy less effective owing to virologic resistance
- Bamlanivimab 700 mg plus etesevimab 1400 mg as a single IV infusion
- Administer as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in patients at high risk for progressing to severe COVID-19 and/or hospitalization
Post-exposure prophylaxis
- EUA issued by the FDA for postexposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death
- Bamlanivimab 700 mg plus etesevimab 1400 mg as a single IV infusion together as soon as possible following exposure
-
Criteria includes those who are not fully vaccinated or are not expected to mount an adequate immune response AND
- Were exposed to an infected individual with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), OR
- Are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (eg, nursing homes, prisons)
- NOTE: Not authorized for preexposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus – only after exposure
-
Fully vaccinated definition
- 2-dose vaccine series: 2 weeks after second vaccine dose (eg, Pfizer or Moderna mRNA vaccines)
- Single vaccine series: 2 weeks after a single-dose vaccine (eg, Johnson & Johnson’s Janssen vaccine)
-
Close contact with infected individual (CDC definition)
- Being within 6 feet for a total of >15 minutes
- Providing care at home to someone who is sick
- Having direct physical contact (eg, hugging, kissing)
- Sharing eating or drinking utensils
- Being exposed to respiratory droplets from an infected person (eg, sneezing, coughing)
Dosage Modifications
Renal impairment
- Mild, moderate, or severe: No dose adjustment required
Hepatic impairment
- Mild: No dose adjustment required
- Moderate or severe: Not studied
Dosing Considerations
Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies
Limitations of use
- Not authorized for use in adults hospitalized due to COVID-19
- Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation
- Not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%
-
Not authorized for use in patients, regardless of age
- Who are hospitalized due to COVID-19, OR
- Who require oxygen therapy due to COVID-19, OR
- Who require an increase in baseline oxygen flow rate due to COVID-19 in those on long-term oxygen therapy due to underlying non-COVID-19–related comorbidity
Patient selection
Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of bamlanivimab and etesevimab under the EUA is not limited to the medical conditions or factors listed below
-
Medical conditions or other factors placing patients at higher risk for progressing to severe COVID-19
- Older age (eg, ≥65 yr)
- Obesity or being overweight
- Pregnancy
- Chronic kidney disease
- Diabetes
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or hypertension
- Chronic lung diseases (eg, COPD, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies)
- Having a medical-related technological dependence (eg, tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID 19])
- EUA is not limited to the medical conditions or factors listed above; for additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the CDC website
Dosage Forms & Strengths
IV solution
- Distributed as individual vials
- Bamlanivimab: 700mg/20mL (35mg/mL)
- Etesevimab: 700mg/20mL (35mg/mL)
COVID-19 (EUA)
Distribution paused
- January 24, 2022: Owing to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any United States region
- In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions
Treatment
- Emergency use authorization (EUA) issued by the FDA for treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progressing to severe COVID-19, including hospitalization or death
- Administer bamlanivimab and etesevimab only in combination as a single IV infusion; monotherapy less effective owing to virologic resistance
- ≥40 kg: Bamlanivimab 700 mg plus etesevimab 1400 mg
- >20 kg to <40 kg: Bamlanivimab 350 mg plus etesevimab 700 mg
- >12 kg to 20 kg: Bamlanivimab 175 mg plus etesevimab 350 mg
- 1-12 kg: Bamlanivimab 12 mg/kg plus etesevimab 24 mg/kg
- Administer as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in patients at high risk for progressing to severe COVID-19 and/or hospitalization
Post-exposure prophylaxis
- EUA issued by the FDA for postexposure prophylaxis of COVID-19 in adults and pediatric patients, including neonates, who are at high risk for progression to severe COVID-19, including hospitalization or death
Administer as a single IV infusion together as soon as possible following exposure
-
<18 years weight-based dose
- ≥40 kg: Bamlanivimab 700 mg plus etesevimab 1400 mg
- >20 kg to <40 kg: Bamlanivimab 350 mg plus etesevimab 700 mg
- >12 kg to 20 kg: Bamlanivimab 175 mg plus etesevimab 350 mg
- 1-12 kg: Bamlanivimab 12 mg/kg plus etesevimab 24 mg/kg
-
Criteria includes those who are not fully vaccinated or are not expected to mount an adequate immune response AND
- Were exposed to an infected individual with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), OR
- Are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (eg, nursing homes, prisons)
- NOTE: Not authorized for preexposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus – only after exposure
-
Fully vaccinated definition
- 2-dose vaccine series: 2 weeks after second vaccine dose (eg, Pfizer or Moderna mRNA vaccines)
- Single vaccine series: 2 weeks after a single-dose vaccine (eg, Johnson & Johnson’s Janssen vaccine)
-
Close contact with infected individual (CDC definition)
- Being within 6 feet for a total of >15 minutes
- Providing care at home to someone who is sick
- Having direct physical contact (eg, hugging, kissing)
- Sharing eating or drinking utensils
- Being exposed to respiratory droplets from an infected person (eg, sneezing, coughing)
Dosage Modifications
Renal impairment
- Mild, moderate, or severe: No dose adjustment required
Hepatic impairment
- Mild: No dose adjustment required
- Moderate or severe: Not studied
Dosing Considerations
Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies
Limitations of use
- Not authorized in patients aged ≥2 yr who are hospitalized due to COVID-19
- Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation
- Not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%
-
Not authorized for use in patients, regardless of age
- Who are hospitalized due to COVID-19, OR
- Who require oxygen therapy due to COVID-19, OR
- Who require an increase in baseline oxygen flow rate due to COVID-19 in those on long-term oxygen therapy due to underlying non-COVID-19–related comorbidity
Patient selection
Other medical conditions or factors (for example, race or ethnicity) may also placeindividual patients at high risk for progression to severe COVID-19 and authorizationof bamlanivimab and etesevimab under the EUA is not limited to the medical conditions or factors listed below
-
Medical conditions or other factors placing patients at higher risk for progressing to severe COVID-19
- Age <1 year
- Obesity or being overweight
- Pregnancy
- Chronic kidney disease
- Diabetes
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or hypertension
- Chronic lung diseases (eg, COPD, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies)
- Having a medical-related technological dependence (eg, tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID 19])
- EUA is not limited to the medical conditions or factors listed above; for additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the CDC website
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Adverse Effects
EUA requirement
Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory
1-10%
Infusion-related reactions (1.1%)
<1%
Nausea (<1%)
Dizziness (<1%)
Pruritus (<1%)
Anaphylaxis (0.07%)
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Warnings
Contraindications
None
Cautions
Hypersensitivity
- Potential for serious hypersensitivity reaction, including anaphylaxis
- If signs and symptoms occur, immediately discontinue IV infusion and initiate appropriate medications and/or supportive care
- Infusion-related reactions reported, including fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, diaphoresis
Clinical worsening after administration
- Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status
- Some of these events required hospitalization
- Unknown if these events were related to monoclonal antibodies or were due to progression of COVID-19
Severe COVID-19
- Treatment benefit not observed in patients hospitalized due to COVID-19
- Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation
-
Not authorized for use in patients
- Who are hospitalized due to COVID-19, OR
- Who require oxygen therapy due to COVID-19, OR
- Who require an increase in baseline oxygen flow rate due to COVID-19 in those on long-term oxygen therapy due to underlying non-COVID-19–related comorbidity
Viral variants
- Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies
- Prescribing clinicians should consider prevalence of resistant variants in their area
- Health care providers should review antiviral resistance information provided by state and local health departments
- Variant proportions circulating in the US can be monitored at the CDC website
Drug interaction overview
- Not renally excreted or metabolized by CYP450 enzymes
- Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely
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Pregnancy & Lactation
Pregnancy
Insufficient data to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Use during pregnancy only if potential benefit outweighs the potential risk for the mother and fetus
Pregnancy is a risk factor for severe COVID-19 disease
No dosage adjustment recommended by the manufacturer
Lactation
Data are unknown regarding presence in human or animal milk, effects on breastfed infants, or effects on milk production
Maternal IgG is known to be present in human milk
Breastfeeding females with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19
No dosage adjustment recommended by the manufacturer
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Previous
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Pharmacology
Mechanism of Action
Bamlaniviamb and etesevimab are recombinant neutralizing human IgG1-kappa monoclonal antibodies (mAb) to the spike protein of SARS-CoV-2, and are unmodified in the Fc region
Etesevimab and bamlanivimab bind to different but overlapping epitopes in the receptor-binding domain of the S-protein; using both antibodies together is expected to reduce the risk of viral resistance
Binding sites
- Etesevimab binds to spike protein with a dissociation constant KD = 6.45 nM and blocks spike protein attachment to human ACE2 receptor with an IC50 value of 0.046 mcg/mL
- Bamlanivimab binds to spike protein with a dissociation constant KD = 0.071 nM and blocks spike protein attachment to human ACE2 receptor with an IC50 value of 0.025 mcg/mL
Pharmacogenomics
Genotypic and phenotypic testing are ongoing to monitor for potential bamlanivimab resistance-associated spike variations in clinical trials
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Administration
IV Preparation
Remove drugs (2 vials etesevimab and 1 vial bamlanivimab) from refrigerator and allow drug to equilibrate to room temperature (~20 min) before preparation; do not expose to direct heat; do not shake
Inspect for particulate matter and discoloration; solution should appear clear to slightly opalescent and colorless to slightly yellow to brown
Dilution
- Withdraw 20 mL from 1 bamlanivimab vial and 40 mL from 2 etesevimab vials and inject all 60 mL into a prefilled infusion bag (ie, 50-250 mL) containing 0.9% NaCl
- Discard any product remaining in vials (unless preparing doses for children weighing <40 kg)
- Gently invert IV bag by hand ~10 times to mix; do not shake
- Administer immediately after preparation; if unable to administer immediately, store according to directions
Pediatric doses (<18 years weighing <40 kg)
- Single-dose vials may be used to prepare more than1 pediatric dose
- Pediatric doses do not need to be diluted for patients aged <18 years who weigh <40 kg
IV Administration
If solution refrigerated, allow to equilibrate to room temperature for ~20 minutes
Administer IV via pump or gravity according to size of infusion bag used
Infuse by PVC infusion set containing 0.20/0.22-micron in-line polyethersulfone (PES) filter
Attach infusion set to IV bag and prime infusion set
Owing to potential overfill of prefilled saline bags, administer entire infusion solution in bag to avoid underdosage
Flush line with 0.9% NaCl after infusion completed to ensure entire dose delivered
Discard unused product
Monitor during infusion and observe patients for at least 1 hr after infusion completed
Use of closed system transfer devices, elastomeric pumps, and pneumatic transport with bamlanivimab has not been studied
Maximum infusion rates
-
Adults and children aged <18 yr (weight at least 40 kg)
- Maximum infusion rate for all infusion bags: 310 mL/hr
- 50-mL bag: Infuse over at least 21 min; 310 mL/hr
- 100-mL bag: Infuse over at least 31 min; 310 mL/hr
- 150-mL bag: Infuse over at least 41 min; 310 mL/hr
- 250-mL bag (weight >40 kg to <50 kg): Infuse over at least 70 min; 266 mL/hr
- 250-mL bag (weight ≥50 kg): Infuse over at least 60 min; 310 mL/hr
-
Children aged <18 yr (weight <40 kg)
- >20 kg to <40 kg; dose 350 mg/700 mg: 1.88 mL/min
- >12 kg to <20 kg; dose 175 mg/350 mg: 0.94 mL/min
- >11 kg to 12 kg; dose 138 mg/276 mg: 0.74 mL/min
- >10 kg to 11 kg; 126 mg/ 252 mg: 0.68 mL/min
- >9 kg to 10 kg; 114 mg/228 mg: 0.61 mL/min
- >8 kg to 9 kg; 102 mg/204 mg: 0.54 mL/min
- >7 kg to 8 kg; 90 mg/180 mg: 0.48 mL/min
- >6 kg to 7 kg; 78 mg/156 mg: 0.42 mL/min
- >5 kg to 6 kg; 66 mg/132 mg: 0.36 mL/min
- >4 kg to 5 kg; 54 mg/108 mg: 0.29 mL/min
- >3 kg to 4 kg; 42 mg/84 mg: 0.23 mL/min
- >2 kg to 3 kg; 30 mg/60 mg: 0.16 mL/min
- >1.5 kg to 2 kg; 21 mg/42 mg: 0.11 mL/min
- 1-1.5 kg; 15 mg/30 mg 0.08 mL/min
Storage
Preservative-free product
Unopened vials
- Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
- Do not freeze, shake, or expose to direct light
Diluted solution
- Refrigerate at 2-8ºC (36-46ºF) for up to 24 hr OR
- Room temperature 20-25ºC (68-77ºF) for up to 7 hr
- These storage times include the infusion time
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Images
No images available for this drug.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
