Am I Eligible for Pemgarda? Plus, 6 Other FAQs About This Preventive COVID-19 Medication
Pemgarda was recently authorized for use to prevent COVID-19 in certain individuals. Find out if you can use monoclonal antibodies for COVID with this guide.
Pemgarda
Used for COVID-19
Used for COVID-19
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.
What is Pemgarda (pemivibart)?
What is Pemgarda (pemivibart) used for?
- 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
How Pemgarda (pemivibart) works
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.
Drug facts
| Common Brands | Pemgarda |
|---|---|
| Drug Class | Monoclonal antibody |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Not FDA-approved yet |
More on Pemgarda (pemivibart) essentials
Side effects of Pemgarda (pemivibart)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Infusion-related reactions (9%)
- Upper respiratory tract infection (6%)
- Viral infection (4%)
- Flu-like symptoms (3%)
- Feeling tired (3%)
- Headache (2%)
- Nausea (2%)
- Infusion site reactions (2%)
Pemgarda (pemivibart) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: rash or hives; trouble breathing; dizziness; swelling of the face, eyes, lips, tongue, or throat
The following Pemgarda (pemivibart) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Pemgarda (pemivibart)
Pros
- 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
Cons
- 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
Pharmacist tips for Pemgarda (pemivibart)
- 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.
Risks and warnings for Pemgarda (pemivibart)
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.
Serious allergic reaction
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.
Infusion-related reactions
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.
Caution in people with a history of allergic reaction to COVID-19 vaccine
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.
Pemgarda (pemivibart) dosage
Typical dosage for Pemgarda (pemivibart)
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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