pemivibart
Anaphylaxis
Anaphylaxis has been observed with PEMGARDA in 4 of 623 (0.6%) participants in a clinical trial [see Adverse Reactions (6.1)]. Two participants had anaphylaxis during the first infusion, and two participants had anaphylaxis during the second infusion. Anaphylaxis can be lifethreatening, and two of the anaphylactic reactions in the clinical trial were reported as lifethreatening. Manifestations included pruritus, flushing, urticaria, erythema, angioedema, diaphoresis, dizziness, tinnitus, wheezing, dyspnea, chest discomfort, and tachycardia. In all 4 cases, PEMGARDA was permanently discontinued.
Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis [Adverse Reactions (6.1), and Clinical Studies (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.
Monitoring data
Clinically monitor individuals during the 60-minute infusion and for at least two hours after completion of the infusion. If signs or symptoms of an anaphylactic reaction occur, immediately discontinue administration, and initiate appropriate medications and/or supportive therapy. Discontinue PEMGARDA use permanently in individuals who experience signs or symptoms of anaphylaxis [see Contraindications (4)].
Patient counseling
Inform individuals that anaphylaxis has been observed with PEMGARDA. Advise individuals that they will be monitored during and for at least two hours after completion of the infusion. In those who experience signs or symptoms of anaphylaxis, PEMGARDA use will be discontinued permanently [see Boxed Warnings, and Warnings and Precautions (5.1)]