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FDA Authorizes Revisions to Evusheld Dosing

February 25, 2022

The Food and Drug Administration (FDA) has revised the emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients.

Based on the most recent information and data available, Evusheld may be less active against certain Omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose.

What clinical pharmacists should know:

  • Health care professionals should contact patients who received the previously authorized Evusheld dose to return for an additional 150 mg tixagevimab and 150 mg cilgavimab dose as soon as possible.
  • The volume of each injection for the new, higher dose will be larger, 3 mL instead of 1.5 mL. This means that the injections should be limited to large muscles on the body that can accommodate this volume (e.g., the gluteal muscles).
  • Health care professionals should review the updated Fact Sheets and Dear Health Provider Letter for Evusheld.
  • As part of the EUA, FDA requires health care providers who prescribe Evusheld to report all medication errors and serious adverse events considered to be potentially related to Evusheld through FDA’s MedWatch Adverse Event Reporting program. Providers can complete and submit the report online; or download and complete the form and then submit it via fax at 1-800-FDA-0178.

See the full text of the revised authorization for more details.

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