- Mark Abramowicz, M.D., President: no disclosure or potential conflict of interest to report
- Jean-Marie Pflomm, Pharm.D., Editor in Chief: no disclosure or potential conflict of interest to report
- Brinda M. Shah, Pharm.D., Consulting Editor: no disclosure or potential conflict of interest to report
- Michael Viscusi, Pharm.D., Associate Editor: no disclosure or potential conflict of interest to report
- Discuss the new dosing interval recommendation for tixagevimab/cilgavimab (Evusheld) for prevention of COVID-19.
The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6 months in patients who require ongoing protection against COVID-19.1 Evusheld is authorized for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise.2
The revision was based on pharmacologic modeling data, which suggest that tixagevimab and cilgavimab retain activity against currently circulating variants of SARS-CoV-2 (including the Omicron variants BA.2, BA.2.12.1, BA.4, and BA.5) for 6 months after administration of a 300-mg dose of each antibody.2
The recommended dosage of Evusheld is 300 mg of tixagevimab and 300 mg of cilgavimab given as two consecutive IM injections once every 6 months. Patients should be monitored for at least 1 hour after administration. Evusheld should not be used for treatment or post-exposure prophylaxis of COVID-19, or within 2 weeks after administration of a COVID-19 vaccine.2
- FDA. FDA authorizes revisions to Evusheld dosing. June 29, 2022. Available at: https://bit.ly/3K5AcNc. Accessed July 11, 2022.
- FDA. Fact sheet for health care providers: Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab). June 2022. Available at: https://bit.ly/3IWpQjg. Accessed July 11, 2022.