What is Bamlanivimab?
Bamlanivimab is an investigational neutralizing human immunoglobulin G-1 (IgG1) monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Indication for Use
Bamlanivimab is not an FDA-approved medication; however, the drug has been authorized for use under an Emergency Use Authorization (EUA) to treat mild to moderate COVID-19 in patients 12 years and older weighing at least 40 kg with positive SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 or hospitalization.
Patients are deemed to be at high risk for progressing to severe COVID-19 or requiring hospitalization if they meet at least 1 of the following criteria:
- Body mass index (BMI) greater than or equal to 35
- Chronic kidney disease
- Immunosuppressive disease or receiving immunosuppressive therapy
- 65 years or older
- 55 years or older AND have:
- Cardiovascular disease OR
- Hypertension OR
- Chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
Dosage and Administration
**Bamlanivimab should be administered as soon as possible after a positive viral test of SARS-CoV-2. Give within 10 days of symptom onset (average in study was 3 days).
- 700mg/20ml solution for injection—this is a concentrated solution that must be diluted prior to administration.
- Single IV infusion of 700 mg Bamlanivimab administered over at least 60 minutes.
- Refrigerate unopened vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
- Allow to equilibrate to room temperature before preparation for approximately 20 minutes. Gently invert vial(s) by hand to mix. Do not shake.
- Dilute Bamlanivimab concentrated solutions using 0.9% sodium chloride for intravenous infusions. Gently invert IV bag to mix. Do not shake. Administer the infusion at a rate of 200 mL/hr over 60 minutes. See Lilly’s Bamlanivimab Antibody Playbook for more details regarding dilution.
- This product is preservative free and therefore, the prepared solution should be administered immediately. If immediate administration is not possible, store the diluted Bamlanivimab solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) or up to 7 hours at room temperature (20°C to 25°C [68°F to 77°F]) including infusion time. Discard unused product.
- Ideal for SNF
- Must be administered in a setting in which health care providers have immediate access to medications used to treat a severe infusion reaction and the ability to activate the emergency medical system, as necessary.
PLEASE NOTE: Bamlanivimab is not authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy for COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 if already on chronic oxygen therapy for an underlying condition. Use of the drug in hospitalized patients with COVID-19 who require high flow oxygen or mechanism ventilation may be associated with worsening clinical outcomes.
Allocation Flow of Inventory in the U.S.
The federal government is responsible for the appropriate allocation to state and territory health departments based on COVID-19 rates. These health departments will provide AmerisourceBergen a list of selected sites of care to receive designated doses each week. Sites that have been allocated product will be contacted by and can agree to accept shipments from AmerisourceBergen, a distributor.
At present time pharmacies do not have access to this product and cannot distribute to customers.
4. Clinical Pharmacology