bamlanivimab

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What are the storage requirements for bamlanivimab alone?

Refrigerate unopened bamlanivimab 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 Emergency Use Authorization

Bamlanivimab has not been approved, but has been authorized for emergency use by FDA, to treat 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 is authorized only 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 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.1,2

For information on the authorized use of bamlanivimab 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 bamlanivimab.com. 

Bamlanivimab Fact Sheet for Healthcare Providers

Bamlanivimab Storage

Refrigerate unopened bamlanivimab 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 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 infusion time.2

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

Bamlanivimab Additional Clinical Data

Storing Opened/In-Use Vials

Lilly does not recommend storing a bamlanivimab vial that is in-use to prepare the infusion solution later. Lilly has no information to support this practice. 

The formulation of bamlanivimab contains no preservative. Once the stopper of the vial is punctured the vial is in-use and the content of the vial must be used to prepare the bamlanivimab solution for infusion.

Storage and Stability of the Solution for Infusion

The exposure of the bamlanivimab solution for infusion to conditions of “normal” room light is not of concern when the solution for infusion is used and stored under the following conditions described in Bamlanivimab Storage.

The formulation of bamlanivimab contains no preservative. As directed in the Fact Sheet for Healthcare Providers, the diluted infusion solution should be administered immediately.2

If immediate administration is not possible, store the diluted bamlanivimab 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 infusion time.

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

The time allowances are calculated from the time the vial was removed from refrigeration to prepare the solution for infusion, transportation of the solution for infusion up to and including infusion time. 

References

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

1United States Food and Drug Administration. Bamlanivimab FDA Emergency Use Authorization Letter. Issued November 9, 2020. Accessed November 9, 2020. http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization-letter.pdf

2U. S. Food and Drug Administration (FDA). Fact Sheet for Health Care Providers. Emergency Use Authorization (EUA) of bamlanivimab. 2021.

Glossary

COVID-19 = coronavirus disease 2019

EUA = emergency use authorization

FDA = Food and Drug Administration

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

Date of Last Review: March 03, 2021


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