injection 700 mg/20 mL
Emergency Use Authorization (EUA) for the Treatment of COVID-19
The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of bamlanivimab to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, bamlanivimab, for the treatment of COVID-19.
- Bamlanivimab has not been approved, but has been authorized for emergency use by FDA.
- Bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Health care providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish).
Limitations of Authorized Use
Bamlanivimab is 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 chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes in hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
What is bamlanivimab?
Bamlanivimab, pronounced: (bam” la niv’ i mab)
Mechanism of Action
Bamlanivimab is a recombinant neutralizing human IgG1κ monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region. Bamlanivimab binds to spike protein with a dissociation constant KD = 0.071 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.025 µg/mL.
- Designed to block viral attachment and entry into human cells, thus potentially neutralizing the virus, and treating COVID-19
- Identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19
- Emerged from the collaboration between Eli Lilly and AbCellera™
Instructions for Administration
Patient Selection
Bamlanivimab should be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in adults and pediatric patients (12 years of age and older weighing at least 40 kg), who are at high risk for progressing to severe COVID-19 and/or hospitalization.
High risk is defined as patients who meet at least one of the following criteria:
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
-
Are ≥55 years of age AND have
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic respiratory disease.
-
Are 12 – 17 years of age AND have
- BMI ≥85th percentile for their age and gender based on CDC growth charts, OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders, for example, cerebral palsy, OR
- a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease that requires daily medication control.
Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease.
There are no known contraindications for bamlanivimab.
Additional Information for Healthcare Providers:
- Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bamlanivimab and mandatory requirements of the EUA.
- Healthcare providers must provide a copy of the Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish) to patients and/or caregivers prior to treatment.
- Bamlanivimab must be administered intravenously. The authorized dosage is a single intravenous (IV) infusion of 700 mg bamlanivimab administered over 60 minutes via pump or gravity. Bamlanivimab should be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset. See more information regarding dosing in the Fact Sheet for Healthcare Providers.
MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or online here.