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Pemivibart



General

Brand Names: U.S.

  • Pemgarda

Indications

Use: Labeled Indications

See "Use: Off-Label."

Contraindications

Severe hypersensitivity (eg, anaphylaxis) to pemivibart or any component of the formulation.

ALERT: U.S. Boxed Warning

Anaphylaxis:

Anaphylaxis has been observed with pemivibart in 0.6% (4/623) of participants in a clinical trial. Anaphylaxis was reported during the first and second infusion of pemivibart. Anaphylaxis can be life-threatening. Prior to administering pemivibart, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis. Administer pemivibart 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 pemivibart immediately if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy.

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