PEMGARDA® is authorized for use in certain moderately to severely immunocompromised patients to help prevent COVID-191
Help protect your vulnerable patients (12 years of age and older weighing at least 40 kg [88 lbs]) against the risks of getting COVID-19 with pre-exposure prophylaxis using PEMGARDA intravenous infusion.1
Medical conditions or treatments that may result in moderate-to-severe immune compromise and an inadequate immune response to COVID-19 vaccination include1:
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Active treatment for solid tumor and hematologic malignancies
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Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy
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Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy)
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Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
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Moderate or severe primary immunodeficiency (eg, common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)
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Active treatment with high-dose corticosteroids (ie, ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, and biologic agents that are immunosuppressive or immunomodulatory (eg, B-cell-depleting agents)
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Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (eg, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, multiple myeloma, acute leukemia)
AIDS, acquired immunodeficiency syndrome; CD4, cluster of differentiation 4; HIV, human immunodeficiency virus.
After the initial dose of PEMGARDA, for the first time in 4.5 years, I felt I had meaningful protection. The playing field finally felt a little more level.”
Criteria for issuance of emergency use authorization
Per the Letter of Authorization from the FDA, the emergency use of PEMGARDA for pre-exposure prophylaxis of COVID-19 meets the criteria for issuance of an authorization because2:
- SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus
- Based on the totality of scientific evidence available to FDA, it is reasonable to believe that PEMGARDA may be effective for use as pre-exposure prophylaxis of COVID-19 in certain adults and adolescents, as described in the Scope of Authorization (Section II), and that, when used under the conditions described in this authorization, the known and potential benefits of PEMGARDA outweigh the known and potential risks of such product
- There is no adequate, approved, and available alternative to the emergency use of PEMGARDA for pre-exposure prophylaxis of COVID-19 in individuals who are unlikely to mount an adequate immune response to COVID-19 vaccination
PEMGARDA has been authorized by FDA for the emergency use described below. PEMGARDA is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.1
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.1
PEMGARDA is available
Help prevent COVID-19 in your moderately to severely immunocompromised patients.
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