Bamlanivimab (Page 4 of 12)

1 AUTHORIZED USE

1.1 TREATMENT

Bamlanivimab and etesevimab administered together are authorized for use under an EUA for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Limitations of Authorized Use

• Bamlanivimab and etesevimab are not authorized for treatment of mild to moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency.
  • FDA’s determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.1
• Bamlanivimab and etesevimab are not authorized for use in patients 2 years and older who are hospitalized due to COVID-19.2
• Bamlanivimab and etesevimab are 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 bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation [see Warnings and Precautions (5.3)].

1.2 POST-EXPOSURE PROPHYLAXIS

Bamlanivimab and etesevimab administered together are authorized for use under an EUA for post-exposure prophylaxis of COVID-19 in adults and pediatric individuals, including neonates, who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:

• not fully vaccinated 3 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications 4) and
  • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)5 or
  • who 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 (for example, nursing homes, prisons).

Limitations of Authorized Use

• Bamlanivimab and etesevimab are not authorized for post-exposure prophylaxis of COVID-19 in geographic regions where exposure is likely to have been to a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency.
  • FDA’s determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.1
• Post-exposure prophylaxis with bamlanivimab and etesevimab is not a substitute for vaccination against COVID-19.
• Bamlanivimab and etesevimab are not authorized for pre-exposure prophylaxis for prevention of COVID-19.

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

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 (for example age ≥65 years of age)
• <1 year old
• 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 (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
• Sickle cell disease
• Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
• Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19))

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 above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Healthcare providers should consider the benefit-risk for an individual patient.

2.2 Dosage

Treatment:

The dosage in adults (18 years and older) and pediatric patients (<18 years and weighing at least 40 kg) is bamlanivimab 700 mg and etesevimab 1,400 mg. The dosage for pediatric patients weighing less than 40 kg will vary depending on body weight:

• >20 kg to <40 kg: 350 mg bamlanivimab and 700 mg etesevimab
• >12 kg to 20 kg: 175 mg bamlanivimab and 350 mg etesevimab
• 1 kg to 12 kg: 12 mg/kg bamlanivimab and 24 mg/kg etesevimab

The recommended dosing regimen for pediatric patients ≤12 kg is predicted based on pharmacokinetic modeling and simulation [see Clinical Pharmacology (14.3)]. The youngest participant in the pediatric clinical trial for treatment was 10 months of age and weighed 8.6 kg [see Use in Specific Populations (11.3) and Clinical Trials and Supporting Data for EUA (18.1)].

For treatment of COVID-19, 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.

Post-Exposure Prophylaxis:

The dosage in adults (18 years and older) and pediatric individuals (<18 years and weighing at least 40 kg) is 700 mg bamlanivimab and 1,400 mg etesevimab administered together as a single intravenous infusion. The dosage for pediatric individuals weighing less than 40 kg will vary depending on body weight:

• >20 kg to <40 kg: 350 mg bamlanivimab and 700 mg etesevimab
• >12 kg to 20 kg: 175 mg bamlanivimab and 350 mg etesevimab
• 1 kg to 12 kg: 12 mg/kg bamlanivimab and 24 mg/kg etesevimab

The recommended dosing regimen for pediatric patients ≤12 kg is predicted based on pharmacokinetic modeling and simulation [see Clinical Pharmacology (14.3)]. The youngest participant in the pediatric clinical trial for treatment was 10 months of age and weighed 8.6 kg [see Use in Specific Populations (11.3) and Clinical Trials and Supporting Data for EUA (18.1)]. Children were not enrolled in the post-exposure prophylaxis trial, BLAZE-2 [see Clinical Trials and Supporting Data for EUA (18.2)].

For post-exposure prophylaxis, bamlanivimab and etesevimab should be given together as soon as possible following exposure to SARS-CoV-2.

Under this EUA, bamlanivimab and etesevimab must be administered together as a single intravenous infusion.

2.3 Dosage Adjustment in Specific Populations

Pregnancy or Lactation

No dosage adjustment is recommended in pregnant or lactating women [see Use in Specific Populations (11.1, 11.2)].

Pediatric Use

No dosage adjustment is recommended in pediatric patients <18 years who weigh at least 40 kg. For pediatric patients weighing less than 40 kg, dosage adjustment on the basis of body weight is required [see Dosage and Administration (2.4)]. The recommended dosing regimen for pediatric patients ≤12 kg is predicted based on pharmacokinetic modeling and simulation [see Clinical Pharmacology (14.3)]. The youngest participant in the pediatric clinical trial for treatment was 10 months of age and weighed 8.6 kg [see Use in Specific Populations (11.3) and Clinical Trials and Supporting Data for EUA (18.1)]. Children were not enrolled in the post-exposure prophylaxis trial, BLAZE-2 [see Clinical Trials and Supporting Data for EUA (18.2)].

Geriatric Use

No dosage adjustment is recommended in geriatric patients [see Use in Specific Populations (11.4)].

Renal Impairment

No dosage adjustment is recommended in patients with renal impairment [see Use in Specific Populations (11.5)].

Hepatic Impairment

No dosage adjustment is recommended in patients with mild hepatic impairment. Bamlanivimab and etesevimab has not been studied in patients with moderate or severe hepatic impairment [see Use in Specific Populations (11.6)].