bamlanivimab and etesevimab together

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What are the storage requirements for bamlanivimab and etesevimab together?

Refrigerate unopened vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze, shake, or expose to direct light.

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Bamlanivimab and Etesevimab Emergency Use Authorization

Bamlanivimab and etesevimab have not been approved, but have only been authorized for emergency use by FDA to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.1,2

Bamlanivimab and etesevimab are authorized to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.1,2

For information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at BAMandETE.com.

Bamlanivimab and Etesevimab Fact Sheet for Healthcare Providers

Bamlanivimab and Etesevimab Storage

Refrigerate unopened vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze, shake, or expose to direct light.2

If immediate administration is not possible, store the diluted infusion solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) and up to 7 hours at room temperature (20°C to 25°C [68°F to 77°F]) including transportation and infusion time.2

If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 20 minutes prior to administration.2

Bamlanivimab and Etesevimab Additional Clinical Data

Storage and Stability of the Solution for Infusion

The bamlanivimab and etesevimab together Fact Sheet for Healthcare providers does not require that the prepared solution for infusion be protected from “normal” room light when the solution for infusion is used and stored under the following conditions described in Bamlanivimab and Etesevimab Storage.2,3

Bamlanivimab and etesevimab contain no preservative. Once the stopper of the vial is punctured the vial is "in-use" and the solution for infusion must be prepared. 3

The following “in-use” storage time allowances must be calculated from the time the vial is removed from refrigeration to prepare the solution for infusion, transportation of the solution for infusion up to and including infusion time, as directed in Bamlanivimab and Etesevimab Storage.3 

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1United States Food and Drug Administration. Bamlanivimab and Etesevimab FDA Emergency Use Authorization Letter. Issued February 9, 2021. Accessed February 9, 2021. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf

2Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. US Food and Drug Administration (FDA). 2021.

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

BAM = bamlanivimab

COVID-19 = coronavirus disease 2019

ETE = etesevimab

EUA = emergency use authorization

FDA = Food and Drug Administration

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

Date of Last Review: February 19, 2021


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