Pemgarda (pemivibart) is a medication that's used to prevent COVID-19 infection in people 12 years and older. It can only be used for people who aren't currently infected with COVID-19, who haven't been recently exposed to it, and who have a weakened immune system. Pemgarda (pemivibart) received emergency use authorization (EUA) from the FDA in March 2024. It's given as a single infusion into the veins, but can be repeated every 3 months. Some potential side effects include infusion reactions, feeling tired, and headache.
Prevention of COVID-19 infection in people 12 years and older weighing at least 88 lbs who:
Aren't infected with COVID-19, and
Haven't been recently exposed to anyone with COVID-19, and
Have moderate-to-severe immune system compromise (weakened immune system) due to a medical condition or from immunosuppressant medications and aren't likely to get enough protection with COVID-19 vaccination
Pemgarda (pemivibart) is a monoclonal antibody. It works by blocking the COVID-19 virus from attaching to and entering your cells. This prevents the virus from spreading in your body and from causing infection.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
An option for people with a very weak immune system for ongoing protection against COVID-19 infection
Can be used for certain children as young as 12 years old
Can be used for people with liver or kidney problems
Only available as an intravenous (IV) infusion
Must be given by a healthcare professional in a clinic or hospital setting
Requires monitoring for allergic reactions for at least 2 hours after each dose
Plan a few hours to get your Pemgarda (pemivibart) infusion. The infusion typically takes about an hour. Then, your care team will want to watch you for at least 2 more hours to make sure you're not having an allergic reaction. Bring a book or something to do to pass the time.
Some people might need ongoing protection against COVID-19 infection. Ask your primary care provider if you need to get additional doses of Pemgarda (pemivibart), which are given every 3 months. Mark your calendar so you don't miss your doses.
Pemgarda (pemivibart) can cause allergic reactions and infusion-related reactions during the infusion and for up to 24 hours after your infusion. Call your primary care provider if you have chills, headache, or dizziness to see how to best manage these reactions.
Get medical help right away if you experience a rash, swelling in your face, tightening of your throat, or trouble breathing at any time during your Pemgarda (pemivibart) infusion or after you get home. These are signs of a serious allergic reaction, which is a medical emergency.
The COVID-19 virus can change in ways that make Pemgarda (pemivibart) not work well against it anymore. This means that you can still get infected with COVID-19 after your Pemgarda (pemivibart) infusion. Take a COVID test if you have signs of COVID-19, like fever, headache, or cough. Call your primary care provider if the results are positive; you might have a COVID-19 infection and need treatment.
Pemgarda (pemivibart) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Rarely, Pemgarda (pemivibart) can cause serious allergic reactions that can be life-threatening (i.e., anaphylaxis). Because of this risk, your healthcare team will watch for signs of an allergic reaction during your infusion and for at least 2 hours after. But it's still possible to experience an allergic reaction after you go home. Get medical help right away if you have hives, dizziness, trouble breathing, chest discomfort, fast heartbeat, or swelling.
Pemgarda (pemivibart) can cause infusion-related reactions during your infusion and for up to 24 hours afterwards. Tell your healthcare team right away if you notice signs of an infusion reaction, such as fever, trouble breathing, chills, chest pain, nausea, headache, dizziness, or rash.
In some cases, the healthcare professional can slow down your Pemgarda (pemivibart) infusion and give you medications to help treat your symptoms. The healthcare professional might need to stop the infusion altogether for more severe reactions.
Pemgarda (pemivibart) contains a substance called polysorbate 80, which is also in some COVID-19 vaccines. This substance can rarely cause an allergic reaction in some people.
Tell your prescriber before taking Pemgarda (pemivibart) if you've had an allergic reaction to a COVID-19 vaccine. Your healthcare team will look out for an allergic reaction during your Pemgarda (pemivibart) infusion and treat it quickly if one happens.
The typical dose is 4,500 mg given as an infusion into the veins (IV) as a single dose. It's administered by a trained healthcare professional.
The dose can be repeated once every 3 months.
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Invivyd, Inc. (2024). Invivyd announces FDA authorization for emergency use of PEMGARDA™ (formerly VYD222) for pre-exposure prophylaxis (PrEP) of COVID-19. Globe Newswire.
Invivyd, Inc. (2024). Pemgarda- pemivibart injection [package insert]. DailyMed.
Nappi, E., et al. (2023). Polyethylene glycol and polysorbate 80 skin tests in the context of an allergic risk assessment for hypersensitivity reactions to anti-SARS-CoV-2 mRNA vaccines. Vaccines.
U.S. Food and Drug Administration. (2024). Frequently asked questions on the Emergency Use Authorization for Pemgarda (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19.
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