⛔ FDA Black Box Warning
WARNING: ANAPHYLAXIS Anaphylaxis has been observed with PEMGARDA in 0.6% (4/623) of participants in a clinical trial. Anaphylaxis was reported during the first and second infusion of PEMGARDA. ( 5.1 , 6.1 ) Anaphylaxis can be life-threatening. Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis. ( 5.1 , 6.1 , 14 ) Administer PEMGARDA only in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary. Clinically monitor individuals during the infusion and for at least two hours after completion of the infusion. Discontinue PEMGARDA use permanently if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy.
Contraindications
4 CONTRAINDICATIONS PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.