The U.S. Food and Drug Administration (FDA) has provided an emergency use authorization (EUA) for a new medicine called Pemgarda™ (pemivibart), aimed at preventing COVID-19 in certain high-risk individuals. This medication is specifically designed for those who are immunocompromised, including people aged 12 and older who weigh at least 88 pounds and have a weakened immune system due to conditions like cancer or treatments that suppress immune responses. The EUA is a mechanism that allows faster access to potentially life-saving treatments during public health emergencies, and despite the official end of the COVID-19 public health emergency, the FDA can still grant EUAs for COVID-19 related treatments.
Pemgarda works by providing pre-exposure prophylaxis against COVID-19, serving as a crucial shield for those whose immune systems might not fully respond to COVID-19 vaccines. It is administered through an infusion once a year at a healthcare facility and has shown promise in clinical trials, significantly reducing the risk of developing symptomatic COVID-19. This is particularly important for the immunocompromised population, who are at greater risk of severe illness and have a diminished response to vaccines. With the ongoing presence of COVID-19 and its variants, Pemgarda offers a new layer of protection, helping vulnerable groups feel safer in managing their health during the pandemic.
If you have questions about Pemgarda infusion or Covid-19 prevention for immunocompromised individuals, please do not hesitate to contact us.
Below is some useful information from the PEMGARDA patient fact sheet:
FAQ List for PEMGARDA (pemivibart) under Emergency Use Authorization (EUA)
- What is PEMGARDA?
PEMGARDA is an investigational medicine authorized for use as pre-exposure prophylaxis to help prevent COVID-19 in adults and children 12 years and older who weigh at least 88 pounds and have moderate-to-severe immune compromise. It is not FDA-approved and is available under an EUA during the COVID-19 pandemic.
- What are the serious side effects of PEMGARDA?
PEMGARDA may cause serious side effects, including anaphylaxis, which is a life-threatening allergic reaction that can occur during or after the infusion. Healthcare providers will monitor patients for signs of anaphylaxis or severe allergic reactions during and after administration.
- Who should not take PEMGARDA?
Do not take PEMGARDA if you have had a severe allergic reaction to PEMGARDA or any of its ingredients.
- How is PEMGARDA administered?
PEMGARDA is administered through a one-time intravenous (IV) infusion over approximately 60 minutes in a healthcare setting. Patients are observed during the infusion and for at least 2 hours afterward.
- What should I discuss with my healthcare provider before receiving PEMGARDA?
Inform your healthcare provider about all your medical conditions, allergies, pregnancy or breastfeeding status, and all medications you are taking, including over-the-counter drugs and supplements.
- Are there any known interactions with COVID-19 vaccines?
If you have received a COVID-19 vaccine, you should wait at least 2 weeks before receiving PEMGARDA. PEMGARDA does not replace vaccination for those who are eligible for COVID-19 vaccines.
- What are other possible side effects of PEMGARDA?
Possible side effects include allergic and infusion-related reactions, infusion site reactions, common cold symptoms, viral infections, flu-like illness, tiredness, headache, and nausea. These are not all the potential side effects, and unexpected side effects may occur since PEMGARDA is still under study.
- What if I am pregnant or breastfeeding?
The effects of PEMGARDA on pregnant or breastfeeding women are unknown. Discuss your options and specific situation with your healthcare provider.
- How can I report side effects with PEMGARDA?
Report any side effects to your healthcare provider, FDA MedWatch, or call Invivyd at 1-800-890-3385.
- What is an Emergency Use Authorization (EUA)?
An EUA allows for the availability of medical products like PEMGARDA during public health emergencies, permitting use when certain statutory criteria are met, including that there are no adequate, approved, and available alternatives.
- How can I learn more about PEMGARDA?
For more information, visit the PEMGARDA website at www.pemgarda.com or contact Invivyd at 1-800-890-3385.
- How can I learn more about COVID-19?
To learn more about COVID-19, consult your healthcare provider, visit the CDC website, or contact your local or state public health department.
