Patient support

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.

Actor portrayal.

What information do you need to help support your use of PEMGARDA?

There are many resources available to assist with access, dosing, site of care considerations, and more.

Download resources
Expand

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.
  • Anaphylaxis can be life-threatening.
  • Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis.
  • 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.
Expand

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.
  • Anaphylaxis can be life-threatening.
  • Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis.
  • 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.

EMERGENCY USE AUTHORIZATION (EUA) FOR PEMGARDA®

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PEMGARDA for the pre-exposure prophylaxis of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg):

  • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
  • Who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate response to COVID-19 vaccination.

Limitations OF AUTHORIZED USE

  • PEMGARDA is not authorized for use for treatment of COVID-19, or for post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.
  • PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90% based on available information including variant susceptibility to PEMGARDA and national variant frequencies.
  • Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccination, should receive COVID-19 vaccination.
  • In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.

PEMGARDA may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.

PEMGARDA has been authorized by FDA for the emergency use described above. It is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.

PEMGARDA is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PEMGARDA under Section 564(b)(1) of the FD&C Act, 21 U.S.C. § 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner.

IMPORTANT SAFETY INFORMATION

PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.

Serious hypersensitivity reactions, including anaphylaxis, and infusion-related reactions can occur during the infusion and up to 24 hours after the infusion of PEMGARDA and may be severe or life threatening. If signs and symptoms of a clinically significant hypersensitivity reaction or infusion-related reaction occur, immediately discontinue administration, and initiate appropriate medications and/or supportive therapy. Permanently discontinue PEMGARDA in individuals who experience signs or symptoms of anaphylaxis.

PEMGARDA contains polysorbate 80, which is in some COVID-19 vaccines and is structurally similar to polyethylene glycol (PEG), an ingredient in other COVID-19 vaccines. For individuals with a history of severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to PEMGARDA administration.

Certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA. PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. Inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 viral variants that exhibit significantly reduced susceptibility to PEMGARDA. If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.

The most common adverse events (all grades, incidence ≥2% and greater than placebo, through Month 6) observed in participants who have moderate-to-severe immune compromise in Cohort A PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, viral infection, upper respiratory tract infection, influenza-like illness, urinary tract infection, fatigue, headache, sinusitis, nasopharyngitis, influenza and pneumonia.

The most common adverse events (all grades, incidence ≥2% and greater than placebo, through Month 6) observed in participants who do not have moderate-to-severe immune compromise in Cohort B treated with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, enterovirus infection, and viral upper respiratory tract infection.

PEMGARDA should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PEMGARDA and any potential adverse effects on the breastfed infant from PEMGARDA.

The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to PEMGARDA within 7 calendar days from the healthcare provider’s awareness of the event. See Section 6.4 of the accompanying Fact Sheet for more information.

Complete and submit the report online: https://www.fda.gov/medwatch/report.htm. See Section 6.4 of the Fact Sheet for additional mechanisms for reporting.

See Fact Sheet for Healthcare Providers and FDA Letter of Authorization.

Reference: PEMGARDA Fact Sheet for healthcare providers. Waltham, MA; Invivyd, Inc.