Last updated: May 5, 2021
On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab, an unapproved agent, to treat mild to moderate cases of the COVID-19 coronavirus. EUAs are not FDA approval. In April 2021, FDA revoked the EUA for bamlanivimab as single-agent therapy for COVID-19. As new variants emerged, data indicated that when administered alone, bamlanivimab’s benefits no longer outweighed its risks. It issued a new EUA for bamlaniviamab when administered in combination with etesevimab.
Neutralizing human IgG1 monoclonal antibody
Adult and pediatric patients with positive SARS-CoV-2 viral testing (the virus that causes COVID-19) who aged 12 years and older and weigh at least 40 kg who are at high risk of progressing to severe COVID-19 or hospitalization. High risk is defined as a patient who meets at least one of the following criteria:
- Body mass index (BMI) ≥ 35
- Chronic kidney disease
- Immunosuppressive disease
- Receiving immunosuppressive treatment
- ≥ 65 years old
- ≥ 55 years old
- Cardiovascular disease
- Chronic obstructive pulmonary disease or other chronic respiratory disease
- 12–17 years old with one of the following
- BMI ≥ 85th percentile for age based on Centers for Disease Control and Prevention growth charts
- Sickle cell disease
- Congenital or acquired heart disease
- Neurodevelopmental disorders such as cerebral palsy
- Medical-related technology dependence (e.g, tracheostomy, gastrostomy)
- Asthma, reactive airway, or other chronic respiratory disease that requires daily medication to control
Limitations of Authorized Use
Bamlanivimab and etesevimab are not authorized for use in patients who meet any of the following criteria:
- Hospitalized with COVID-19
- Require oxygen therapy for COVID-19
- Require an increase in baseline oxygen flow rate because of COVID-19 in those on chronic oxygen therapy because of an underlying non-COVID-19–related comorbidity
Bamlanivimab 700 mg and etesevimab 1,400 mg once, within 10 days of symptom onset and as soon as possible after positive SARS-CoV-2 testing
Give the two medications together as one infusion. Monitor patients during and for at least one hour after the infusion is complete for changes in vital signs, decrease in oxygen saturation level, mental status changes, flushing, palpitations, or changes in baseline physical assessment.
Because clinical data are limited for bamlanivimab, serious and unexpected adverse reactions may occur outside of what is listed here. Signs of a reaction include include fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash (e.g., urticaria, pruritus), myalgia, dizziness, and diaphoresis. Other adverse reactions observed in the clinical trial include nausea, diarrhea, vomiting, dizziness, headache, and itching.
Flush the line after completing the infusion to ensure full dose delivery. Be prepared for a potential hypersensitivity or anaphylactic reaction. Patients receiving bamlanivimab and etesevimab should continue to self-isolate and use infection control measures such as social distancing and wearing a mask. Institutional policies should address the need to isolate patients who require an infusion for treatment of COVID-19 from other patients in the infusion area. Scheduling, timing, and cleaning procedures should be considered. Bamlanivimab and etesevimabshould be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus. No data are available on breastfeeding.
Patient and Caregiver Education
Instruct patients to alert the medical team if they experience new onset symptoms during or after the infusion. Patients' clinical condition may worsen after administration and could require hospitalization, although it may be because of COVID-19 progression and not bamlanivimab. Patients should report symptoms of fever, hypoxia or increased respiratory difficulty, rapid or slow heart rate, fatigue, and altered mental status.
Reporting Adverse Events and Medication Errors
All serious adverse events and medication errors potentially related to bamlanivimab and etesevimab must be reported within seven calendar days of the onset of the event. Serious adverse events include death, life-threatening adverse events, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medical or surgical interventions to prevent death, life-threatening events, hospitalization, disability, or congenital anomalies. Submit event reports to FDA MedWatch using one of the following methods: