Infusion Center Locator

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PEMGARDA™ Infusion Sites of Care:
Sites of care that have experience administering PEMGARDA and/or are available to receive PEMGARDA referrals from your healthcare provider.

Number of active sites
642

      Important Safety Information 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.

      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 treated with 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 Healthcare Providers for more information.

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

      1Based on 2/2025 Fact Sheet Veeva record 222-PP-B-US-00070-2