- 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 warnings about the risk of hypersensitivity reactions with use of tixagevimab/cilgavimab (Evusheld).
The labeling for the investigational, long-acting, prophylactic anti-SARS-CoV-2 monoclonal antibodies tixagevimab and cilgavimab (Evusheld; available under an FDA Emergency Use Authorization) now includes warnings about a risk of serious hypersensitivity reactions, including anaphylaxis, with use of the drugs, particularly in patients who have experienced a hypersensitivity reaction to a COVID-19 vaccine.1,2
Evusheld contains polysorbate 80, an emulsifying agent similar in structure to polyethylene glycol (PEG). Both polysorbate and PEG can cause hypersensitivity reactions, and all of the COVID-19 vaccines currently available in the US (Pfizer/BioNTech, Moderna, Johnson & Johnson/Janssen) contain either polysorbate or PEG. Patients who have experienced a hypersensitivity reaction to a COVID-19 vaccine may be more likely to experience another after receiving Evusheld.1
According to the new labeling, tixagevimab/cilgavimab should be administered in a setting that is equipped to manage severe hypersensitivity reactions. Patients should be monitored for at least 1 hour after the antibodies are injected. Clinicians should consider consulting with an allergist-immunologist before administering Evusheld to a patient who has had a severe hypersensitivity reaction to a COVID-19 vaccine.1
- FDA. Fact sheet for health care providers: Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab). May 2022. Available at: https://bit.ly/3IWpQjg. Accessed June 23, 2022.
- Tixagevimab and cilgavimab (Evusheld) for pre-exposure prophylaxis of COVID-19. Med Lett Drugs Ther 2022; 64:1.