Pemgarda is a brand-name injectable solution prescribed to help prevent COVID-19 in certain situations. Pemgarda contains the active ingredient pemivibart and belongs to the antiviral drug class.

Pemgarda has emergency use authorization (EUA) to help prevent COVID-19 in certain situations in adults and children ages 12 years and older. For details, see the “Pemgarda uses” section below.

Drug details

You’ll find key information about Pemgarda below.

  • Drug form: solution given as an intravenous (IV) infusion
  • Generic or biosimilar available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: see note below

Note: The Food and Drug Administration (FDA) has not fully approved Pemgarda. The drug has been granted an EUA to help prevent COVID-19 in certain situations.

Pemgarda has a boxed warning. A boxed warning is the most serious warning from the FDA. For details, see the “Pemgarda precautions” section below.

Pemgarda is a brand-name biologic drug. It isn’t available in biosimilar form.

Traditional drugs are made using chemicals, while biologics are made using parts of living cells. Traditional drugs have generics that are exact copies of the brand-name form. Instead of generics, biologics have biosimilars because they cannot be copied exactly.

Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug.

The following information describes the dosage of Pemgarda that is commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug form and strength

Pemgarda comes as a solution in a single-use vial. It’s available in one strength of 500 milligrams (mg) per 4 milliliters (mL) of solution (125 mg/mL).

Dosage for COVID-19 prevention

Pemgarda is prescribed to help prevent COVID-19 in certain situations. For details, see the “Pemgarda uses” section below.

The usual dosage of Pemgarda is 4,500 mg (9 vials) per infusion. If needed, your doctor may repeat the infusion every 3 months. They’ll determine the number of infusions you need.

Children’s dosage

Pemgarda is prescribed to help prevent COVID-19 in certain children ages 12 years and older who weigh at least 40 kilograms (kg). This is about 88 pounds (lb).

The dosage of Pemgarda for children is the same as for adults. For details, see “Dosage for COVID-19 prevention” above.

How it’s given

A healthcare professional will give you Pemgarda as an intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given over a period of time. Each Pemgarda infusion is typically given over 60 minutes.

You’ll receive Pemgarda in a hospital, clinic, or infusion center. Pemgarda may cause a severe and life threatening allergic reaction called anaphylaxis (see note below). For this reason, you’ll likely stay in the facility where you received the drug for at least 2 hours after your infusion. This allows your doctor to monitor you closely for anaphylaxis and other serious side effects.

If you have other questions about receiving Pemgarda, talk with your doctor.

Note: Pemgarda has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Pemgarda precautions” section below.

About receiving Pemgarda

Below, you’ll find information about key dosage issues:

  • When to receive: Your doctor will recommend when to receive Pemgarda infusions.
  • If you miss a dose: If you miss an appointment for your Pemgarda infusion, call the hospital, clinic, or infusion center right away to reschedule.
  • Length of use: Pemgarda may be a short-term or long-term treatment. Your doctor can advise on how often you’ll need to receive Pemgarda based on your specific situation.
  • Length of time to work: Pemgarda starts to work after your first dose. Your doctor will monitor you to check whether the drug is working to prevent COVID-19.

Pemgarda can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Pemgarda. These lists do not include all possible side effects.

For more information about the possible side effects of Pemgarda, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs that have been granted an emergency use authorization (EUA). If you would like to notify the FDA about a side effect you’ve had with Pemgarda, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Pemgarda. To learn about other mild side effects, talk with your doctor or pharmacist, or view the drug’s prescribing information.

Mild side effects of Pemgarda can include:

  • fatigue
  • headache
  • mild infection, such as influenza (the flu)
  • nausea
  • mild reactions around the infusion site, such as bruising, discoloration, or skin rash

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Pemgarda aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

Note: Pemgarda has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Pemgarda precautions” section below.

ALLERGIC REACTION

For some people, Pemgarda can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

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.

Note: Pemgarda has a boxed warning for a severe and life threatening allergic reaction called anaphylaxis. This is the most serious warning from the FDA. To learn more, see the “Pemgarda precautions” section below.

The Food and Drug Administration (FDA) approves prescription drugs to treat certain conditions. However, the FDA has not fully approved Pemgarda. The drug has been granted an emergency use authorization (EUA) for a specific use.

Pemgarda for COVID-19 prevention

Pemgarda has an EUA to help prevent COVID-19 in certain adults.

Specifically, the drug is prescribed for adults who may be exposed to COVID-19 and meet all of the following criteria:

  • do not currently have COVID-19
  • have not been in recent contact with a person who has COVID-19
  • have a weakened immune system due to a medical condition or medication, which might prevent a COVID-19 vaccine from working as it should

Doctors can prescribe Pemgarda at least 2 weeks after a COVID-19 vaccine is given.

Doctors will not prescribe Pemgarda to treat an active COVID-19 infection. Nor will they prescribe the drug to prevent COVID-19 after recent contact with a person who has the virus (SARS-CoV-2).

You can learn more about COVID-19 by visiting our COVID-19 hub.

Pemgarda and children

Pemgarda is prescribed to help prevent COVID-19 in certain children ages 12 years and older. The child must weigh at least 40 kilograms (kg), which is about 88 pounds (lb).

Pemgarda is prescribed for children who may be exposed to COVID-19 and meet all of the criteria listed in the section above.

To learn more about Pemgarda for COVID-19 prevention, talk with your child’s doctor.

Pemgarda is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer of Pemgarda did not look at interactions in clinical trials of the drug.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Pemgarda.

Before starting Pemgarda treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

As with all medications, the cost of Pemgarda can vary. The actual price you’ll pay depends on your insurance plan and your location.

Financial and insurance assistance: If you need financial support to pay for Pemgarda or help to understand your insurance coverage, help is available.

The drug’s manufacturer is planning to offer a patient copay support program with certain eligibility requirements. For details on the availability of this program, refer to the drugmaker’s website. Your doctor may be able to provide more information about this program.

Generic or biosimilar version: Pemgarda isn’t available in a biosimilar form. As with generics, biosimilars are considered to be as safe and effective as the original brand-name drug and may cost less. For details about biosimilars, see the “Pemgarda generic or biosimilar” section above.

To learn more about saving money on prescriptions, check out this article.

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Pemgarda and pregnancy

It’s unknown whether Pemgarda should be given during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving this medication.

Pemgarda and breastfeeding

It’s unknown whether Pemgarda should be given while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this medication.

This drug comes with several precautions.

FDA warning: Risk of anaphylaxis

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Pemgarda may cause a severe and life threatening allergic reaction called anaphylaxis. This side effect was rare in the drug’s clinical trials.

With anaphylaxis, you may have symptoms that include:

You’ll receive Pemgarda in a hospital, clinic, or infusion center. Due to the risk of anaphylaxis, you’ll likely stay in the facility where you received the drug for at least 2 hours after your infusion. This allows your doctor to monitor you closely for symptoms of this condition.

Tell your doctor immediately if you have symptoms of anaphylaxis during or after Pemgarda infusions. They’ll likely discontinue your Pemgarda infusions and treat this condition right away.

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 a COVID-19 vaccine
  • recently been in contact with a person who has COVID-19
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Pemgarda, see the “Pemgarda side effects” section above.

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.