Pemgarda (pemivibart) is a brand-name injectable solution that’s prescribed for COVID-19 prevention in some adults and children for certain situations. Pemgarda can cause side effects, such as infusion-related reactions and headache.

Pemgarda has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.

Pemgarda can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Pemgarda in clinical trials:

Mild side effects can occur with Pemgarda use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Pemgarda’s prescribing information.

Mild side effects that have been reported with Pemgarda include:

  • tiredness
  • headache
  • nausea
  • mild infections, such as the common cold and flu-like illness

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Pemgarda and want to tell the FDA about it, visit MedWatch.

Pemgarda may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Pemgarda’s prescribing information.

If you develop serious side effects while taking Pemgarda, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • infusion-related reactions (See “Side effect specifics”)
  • anaphylaxis (See “Side effect specifics”)
ALLERGIC REACTION

For some people, Pemgarda can cause an allergic reaction.

Mild allergic (hypersensitivity) reactions are common side effects reported in the drug’s studies. Sometimes these side effects were also considered infusion-related reactions in Pemgarda’s studies. See the “Side effect specifics” section for more details about infusion-related reactions.

Anaphylaxis, a life threatening allergic reaction, was also reported with Pemgarda treatment. Although rare, Pemgarda has a boxed warning about the risk of anaphylaxis. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Pemgarda, your doctor may recommend taking a different medication instead.

Learn more about some of the side effects that Pemgarda may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Pemgarda.

Anaphylaxis

Pemgarda has a boxed warning for risk of anaphylaxis. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Anaphylaxis is a serious allergic reaction that was rarely reported in Pemgarda studies. Anaphylaxis can be life threatening. For this reason, Pemgarda is given in a healthcare setting, such as a hospital, clinic, or infusion center. Anaphylaxis symptoms may include the following:

  • face, lips, mouth, throat, or tongue swelling
  • trouble breathing
  • chest discomfort
  • flushing
  • itchy, discolored, or irritated skin

What you can do

Tell your doctor about previous allergic reactions you had before starting Pemgarda, including allergic reactions to any COVID-19 vaccines. Pemgarda contains an ingredient called polysorbate 80, which is also found in some COVID-19 vaccines. Polysorbate 80 is similar to polyethylene glycol (PEG), another ingredient found in COVID-19 vaccines. For this reason, you may also have an allergic reaction to Pemgarda if you have had an allergic reaction to a COVID-19 vaccine. Your doctor may recommend you speak to an allergist before starting Pemgarda if you had previous allergic reactions to COVID-19 vaccines.

Your doctor will also monitor you closely for anaphylaxis during and at least 2 hours after your Pemgarda treatment. Tell your doctor immediately if you develop anaphylaxis symptoms. They’ll stop Pemgarda treatment right away. Symptoms may also develop after you leave the hospital, clinic, or infusion center. Call 911 or your local emergency number immediately if you are having a medical emergency.

Infusion-related reactions

Infusion-related reactions, including allergic (hypersensitivity) reactions, were common side effects reported in studies of Pemgarda. They may occur at the infusion site. You may also experience these side effects throughout your body. Typically, side effects were mild or moderate. Rarely, they can be serious or life threatening. You may develop these symptoms during the infusion or up to 24 hours after receiving the infusion.

Symptoms occurring at the infusion site may include the following:

  • bruising
  • redness or discoloration
  • rash
  • extravasation (fluid leaking from the vein into surrounding area)
  • ruptured or blown vein

Symptoms occurring throughout the body may include the following:

  • muscle aches
  • confusion
  • heart rate changes
  • dry, swollen, or itchy skin
  • numbing or burning feeling in the hands or feet
  • feeling faint

What you can do

Tell your doctor about previous allergic reactions you had before starting Pemgarda, including allergic reactions to any COVID-19 vaccine. Pemgarda contains an ingredient called polysorbate 80, which is found in some COVID-19 vaccines. Polysorbate 80 is also similar to polyethylene glycol (PEG), another ingredient found in COVID-19 vaccines. For this reason, you may also have an allergic reaction to Pemgarda if you had an allergic reaction to COVID-19 vaccines. Your doctor may recommend you speak to an allergist before starting Pemgarda if you had previous allergic reactions to COVID-19 vaccines.

Your doctor will also closely monitor you for infusion-related reactions during and at least 2 hours after your Pemgarda treatment. Tell your doctor immediately if you develop any symptoms of infusion-related reactions. Your doctor will stop Pemgarda treatment right away if your symptoms are severe or life threatening. In cases where your symptoms are mild, they may consider slowing the infusion. Symptoms may also develop after you leave the hospital, clinic, or infusion center. Call 911 or your local emergency number immediately if you are having a medical emergency.

Below is important information you should consider before taking Pemgarda.

Pemgarda has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.

Other precautions

Before taking Pemgarda, discuss your health history with your doctor. Pemgarda may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • recently received COVID-19 vaccine
  • recent contact with someone who had COVID-19 infection
  • previous allergic reaction to this, a similar drug, or COVID-19 vaccine
  • pregnancy
  • breastfeeding
  • alcohol consumption

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.