PEMIVIBART INJ,SOLN
Clinical Criteria Summary
Indication & Patient Eligibility
- Pre-exposure prophylaxis (PrEP) of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg)
- Must not be currently infected with SARS-CoV-2
- Must not have had a known recent exposure to an individual infected with SARS-CoV-2
- Must have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications/treatments and may not mount an adequate immune response to COVID-19 vaccination, including:
- Active treatment for solid tumor and hematologic malignancy
- Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia)
- Receipt of solid organ transplant or an islet transplant and taking immunosuppressive therapy
- Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (withing 2 years of transplant or taking current immunosuppressive therapy)
- Moderate to severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV (those with CD4+ cell < 200/mm3, history of AIDS-defining illness without immune reconstitution or clinical manifestations of symptomatic HIV)
- Active treatment with high-dose corticosteroids (i.e., ≥ 20mg/day prednisone or equivalent 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 (e.g., B-cell depleting agents)
Contraindications & Limitations of Use
- Contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis to any component
- NOT authorized for treatment of COVID-19
- NOT authorized for post-exposure prophylaxis of COVID-19 in individuals exposed to someone infected with SARS-CoV-2
- NOT a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended
- Should not be used for at least two weeks after COVID-19 vaccination
- Authorized only when the combined national frequency of variants with substantially reduced susceptibility to PEM is ≤ 90%
Dosing & Administration Requirements
- Single intravenous (IV) infusion of 4500 mg
- Repeat doses every 3 months
- Infused over a minimum of 60 minutes
- No adjustment recommended for hepatic or renal dysfunction, in geriatrics, or in pregnant or lactating persons
- Must be prepared and administered by a qualified healthcare worker using aseptic technique
- Must use an inline 0.2-micron filter
- Entire contents of the bag must be administered; line flushed with 0.9% sodium chloride after completion
Monitoring & Safety Requirements
- Must be administered in a setting where healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system
- Clinically monitor individuals during the 60-minute infusion and for at least 2 hours after completion
- Immediately discontinue administration and initiate appropriate supportive care if signs/symptoms of a severe allergic reaction occur; permanently discontinue PEM in those with anaphylaxis
- For mild infusion-related reactions, consider slowing or stopping the infusion, administer appropriate medications/supportive care, and monitor for 2 hours after discontinuation or completion