Selected adverse reactions

The following selected adverse reactions have been observed in the clinical study of PEMGARDA® that supported the EUA. The adverse reaction rates observed in the clinical study cannot be directly compared to rates in the clinical studies of other products and may not reflect the rates observed in clinical practice.

Additional adverse reactions associated with PEMGARDA may become apparent with more widespread use.

The safety of PEMGARDA is based on exposure of 623 participants who received at least 1 dose of PEMGARDA 4500 mg IV in one of two cohorts in the ongoing CANOPY trial.

Anaphylaxis was observed in 4 of 623 (0.6%) participants in CANOPY, all in Cohort A:

• Two participants had anaphylaxis during the first infusion, and two participants had anaphylaxis during the second infusion. All four reactions led to permanent discontinuation of PEMGARDA. Three participants had complete resolution, and one participant had acute resolution with sequelae related to a flare of an underlying condition.
• Symptoms of anaphylaxis during the first dose included dyspnea, diaphoresis, erythema (face), chest discomfort, and tachycardia in one participant, and flushing, dizziness, tinnitus, and wheezing in one participant. Treatment for both included diphenhydramine.
• Both instances of anaphylaxis with the second dose were reported as life-threatening. Symptoms during the second infusion and following discontinuation of the infusion in both participants included pruritus, urticaria, angioedema, dyspnea, and either erythema or flushing. One participant also experienced headache, dizziness, and chest pain; additionally, pruritus, erythema, and urticaria reoccurred in this participant within 24 hours of the initial onset of anaphylaxis. Both participants were treated with diphenhydramine and epinephrine, and one participant also received oral prednisone and metoprolol for an associated flare of an underlying condition.

Other common adverse events

In addition to systemic and local infusion-related/hypersensitivity reactions, the most common (≥2%) treatment-emergent adverse events, irrespective of causality, observed with PEMGARDA in participants who have moderate-to-severe immune compromise (Cohort A) in CANOPY were viral infection (7%), upper respiratory tract infection (7%), influenza-like illness (4%), urinary tract infection (4%), fatigue (3%), headache (3%), sinusitis (3%), nasopharyngitis (2%), influenza (2%), and pneumonia (2%).

In Cohort B: upper respiratory tract infection (8%), viral infection (6%), influenza-like illness (5%), enterovirus infection (3%), and viral upper respiratory tract infection (2%). These adverse events were observed at a similar or higher rate with placebo.