Pemivibart (Pemgarda)
Anti-Infective Agent | Antiviral
Black Box Warning: Pemivibart carries a black box warning for the risk of anaphylaxis and other hypersensitivity and infusion-related reactions. Anaphylaxis was reported in 0.6% of participants in a clinical trial. It is crucial to monitor patients for signs and symptoms of anaphylaxis during and after the infusion.
Key Clinical Pearls for Pemivibart (Pemgarda)
Indications and Use
- Pemivibart is a monoclonal antibody authorized for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents with moderate to severe immunocompromise.
Dosing and Administration
- Recommended dose is 4,500 mg administered as an intravenous infusion over 60 minutes.
- A second dose may be administered 3 months after the initial dose.
- Administer in settings where healthcare providers have immediate access to medications and equipment to manage anaphylaxis.
Monitoring
- Monitor patients during the infusion and for at least 2 hours after completion for signs/symptoms of anaphylaxis or infusion-related reactions.
- Discontinue infusion immediately if anaphylaxis or severe systemic reactions occur and initiate appropriate treatment.
Adverse Reactions
- Anaphylaxis was observed in 0.6% of clinical trial participants, occurring during the first or second infusion.
- Other reactions include hypersensitivity, infusion-related reactions (fever, chills, nausea, headache, bronchospasm, hypotension, angioedema).
Contraindications
- Previous severe hypersensitivity reactions, including anaphylaxis, to pemivibart or its components.
Drug Interactions
- May reduce immune response to COVID-19 vaccines. Administer pemivibart at least 2 weeks after COVID-19 vaccination.
Patient Education
- Inform patients about the risk of anaphylaxis and instruct them to seek immediate medical attention if symptoms occur.
- Advise patients to continue practicing COVID-19 preventive measures (masking, distancing, etc.) as pemivibart is not a substitute for vaccination.
In summary, pemivibart provides pre-exposure prophylaxis for immunocompromised individuals at high risk for severe COVID-19. Close monitoring for anaphylaxis and proper administration in healthcare settings are crucial.
Citations:
[1] https://www.rxlist.com/pemgarda-drug.htm
[2] https://www.fda.gov/media/177066/download
[3] https://www.cidrap.umn.edu/covid-19/fda-oks-invivyds-covid-preventive-pemgarda-emergency-use
[4] https://reference.medscape.com/drug/pemgarda-pemivibart-4000452
[5] https://www.pharmacytimes.com/view/fda-grants-pemivibart-emergency-use-authorization-for-prep-of-covid-19-in-immunocompromised-patients
Did you find this clinical pearl helpful?
