FDA announces new Evusheld dosing guidelines, shelf-life extension
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The FDA has authorized revisions to Evusheld dosing guidelines, and now recommends repeat dosing every 6 months, with 300 mg of tixagevimab and 300 mg cilgavimab in cases where patients require ongoing shielding from COVID-19.
The announcement comes as a response to the presence and circulation of multiple omicron subvariants, including BA.2, BA.2.12.1, BA.4 and BA.5, in the United States, according to the agency.
“Nonclinical data and pharmacokinetic modeling suggest that activity against these subvariants may be retained for 6 months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab,” the FDA said in a statement. “Therefore, on June 29, 2022, FDA revised the Evusheld fact sheet for health care providers to recommend repeat dosing every 6 months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection.”
The previous update on the dosing guidelines for Evusheld (tixagevimab plus cilgavimab, AstraZeneca), the monoclonal antibody designed to prevent COVID-19, was announced in February. However, that update did not provide a specific recommendation on the dosing interval.
In addition, the FDA and the HHS’ office of the Assistant Secretary for Preparedness and Response announced an authorization of an extended shelf life for Evusheld, from 18 to 24 months for specific lots. The extension gives specified lots of cocktail an additional 6 months of viability. The extension applies to “all unopened vials of Evusheld that have been held in accordance with storage conditions,” according to the FDA.
Proper storage conditions indicate that Evusheld doses must be stored in their original packaging to remain protected from light, and must remain at temperatures between 36° and 48° F, or 2° to 8° C.
A full breakdown of batches, with corrected expiration dates, is available at the FDA website.
References:
Shelf-life extension of Evusheld under emergency use authorization. https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-28June2022.aspx?utm_medium=email&utm_source=govdelivery. June 28, 2022. Accessed June 30, 2022.
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