Pemgarda (pemivibart) is a prescription drug that’s used to help prevent COVID-19 in certain cases. Pemgarda comes as a solution that you receive as an intravenous (IV) infusion.

Pemgarda is used in adults and certain children to help prevent COVID-19. To learn more about Pemgarda’s uses, see the “What is Pemgarda used for?” section.

Pemgarda belongs to the group of drugs called antivirals.

Note: The Food and Drug Administration (FDA) has allowed the use of Pemgarda in the United States under an emergency use authorization (EUA). This means that the drug isn’t fully approved by the FDA, but is allowed to be prescribed because it may be effective in preventing serious disease. Current data shows the drug’s benefits outweigh its risks. But further studies are needed for the drug to be fully FDA-approved.

Pemgarda basics

Pemgarda contains the active ingredient pemivibart.

Pemgarda is a biologic medication. A biologic is made from parts of living organisms. It’s available only as a brand-name drug. It isn’t available in a biosimilar form.

Biosimilars are like generic drugs. But unlike generics, which are made for non-biologic drugs, biosimilars are made from biologic drugs.

Biosimilars will have the same active ingredient core name as the brand-name drug. But they’ll have unique suffixes. This is why “-abcd” appears at the end of the name of the active ingredient. This is to show that it’s distinct from biosimilars that may be created in the future.

Pemgarda has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “What should be considered before taking Pemgarda?” section.

Pemgarda is used* to help prevent COVID-19 infection in adults and in children ages 12 years and older who weigh at least 40 kilograms (kg) or about 88 pounds (lb).

COVID-19 infection is a virus caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). COVID-19 can cause a variety of symptoms. Mild symptoms include fever and cough. But more severe symptoms could include having low amounts of oxygen in your blood, a higher heart rate than usual, or developing pneumonia.

To receive Pemgarda, the following criteria must be met:

  • you currently do not have COVID-19 infection and have not been recently exposed to someone with COVID-19
  • you have a medical condition or take certain medication that makes you moderately to severely immunocompromised, but COVID-19 vaccination likely won’t provide you with adequate protection

Numerous medical conditions and medications can cause a moderate to severe decrease in your immunity. This means your immune system isn’t working as expected, increasing the risk of infection. This means your immune system may not be as protected after receiving a vaccine as a person with an optimally functioning immune system.

Conditions or medications that can make you moderately to severely immunocompromised include:

* The FDA has allowed the use of Pemgarda in the United States under an emergency use authorization (EUA). This means that the drug isn’t fully approved by the FDA, but it’s allowed to be prescribed because it may be effective in preventing a serious disease. Current data shows the drug’s benefits outweigh its risks. But further studies are needed for the drug to be fully FDA-approved.

What is Pemgarda?

Pemgarda is a type of monoclonal antibody. When your body comes in contact with COVID-19 after you’ve received Pemgarda, these antibodies bind the virus. By binding the virus, COVID-19 has a lower chance of invading your cells and making you sick. In this way, Pemgarda works to help prevent COVID-19 infection. But, Pemgarda cannot protect against all possible strains of COVID-19, as the virus mutates (changes) often.

Pemgarda isn’t a substitute for receiving COVID-19 vaccines as recommended by healthcare professionals. Even if you’re moderately or severely immunocompromised, your doctor may still recommend vaccination. You should wait at least 2 weeks after a COVID-19 vaccine before you receive Pemgarda.

Pemgarda isn’t prescribed for the treatment of COVID-19. It also won’t protect you against developing COVID-19 if you’ve recently been in close contact with someone who has the virus.

Like most drugs, Pemgarda may cause mild to serious side effects. The lists below contain some of the more common side effects Pemgarda may cause, but they don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Pemgarda. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a list of some of the mild side effects that Pemgarda can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Pemgarda’s fact sheet.

Mild side effects of Pemgarda that have been reported include:

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Pemgarda can occur. If you have serious side effects from Pemgarda, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Pemgarda that have been reported include:

* For more information, see the “What should be considered before taking Pemgarda?” section.

Allergic reaction

Based on studies, Pemgarda can cause an allergic reaction in some people. Pemgarda has a boxed warning about the risk of anaphylaxis, a life threatening allergic reaction. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “What should be considered before taking Pemgarda?” section.

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

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should keep taking Pemgarda.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Pemgarda, they will permanently stop prescribing it for you.

Your doctor will recommend the dosage of Pemgarda that’s right for you. Below is the commonly used dosage, but the dosage you receive will be determined by your doctor.

Form and strength

Pemgarda is available as a liquid solution that’s given as an intravenous (IV) infusion (an injection into your vein over a period of time). It comes in single-use vials. It has one strength of 500 milligrams (mg) in 4 milliliters (mL) of solution (125 mg/mL).

Recommended dosage

To help prevent COVID-19 infection in adults and children ages 12 years and older weighing at least 40 kilograms (kg), about 88 pounds (lb) in certain cases, your doctor will likely prescribe a Pemgarda dosage of 4,500 mg given as an IV infusion over at least 60 minutes.

You may receive a dose every 3 months. Your doctor will determine when it’s best for you to receive each infusion.

How it’s given

Your doctor will explain how Pemgarda will be given to you. They’ll also explain how much you’ll be given and how often.

Pemgarda is available as a liquid solution that’s given as an IV infusion. You’ll receive infusions at your doctor’s office or a clinic.

You’ll be monitored for 2 hours after your infusion is completed due to the risk of anaphylaxis. Pemgarda has a boxed warning for the risk of anaphylaxis. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “What should be considered before taking Pemgarda?” section.

Questions about taking Pemgarda

Below are some common questions about taking Pemgarda.

  • What if I miss a dose of Pemgarda? If you miss an appointment to receive an infusion of Pemgarda, call your doctor’s office as soon as possible to reschedule.
  • Will I need to use Pemgarda long term? Possibly. If you and your doctor determine that it’s safe and effective for you, you may take Pemgarda long term. Talk with your doctor to learn more about how long you can expect to receive Pemgarda infusions.
  • How long does Pemgarda take to work? Pemgarda begins to work after you receive your first infusion. Your doctor will monitor you throughout treatment to check whether Pemgarda is effective for you.

Below is important information you should consider before taking Pemgarda.

Interactions

Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works. These effects are called interactions.

Pemgarda is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer of Pemgarda didn’t look at interactions in studies.

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.

Pregnancy and breastfeeding

It’s not known whether it’s safe to take Pemgarda during pregnancy or while breastfeeding. If you’re pregnant or breastfeeding, or planning to become pregnant or to breastfeed, talk with your doctor before starting Pemgarda treatment. Your doctor can help you evaluate the potential benefits of receiving Pemgarda against the potential risks to your developing child.

Boxed warning

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

Pemgarda has a boxed warning about the risk of anaphylaxis. Anaphylaxis can be life threatening. Symptoms may include:

  • itchy, discolored, or inflamed skin
  • angioedema
  • wheezing
  • feeling dizzy
  • difficulty breathing.

If you develop anaphylaxis, your doctor may give an antihistamine, such as diphenhydramine (Benadryl), or epinephrine (EpiPen and others).

Due to this risk, you’ll only receive Pemgarda in a facility that can properly treat you should you develop signs of anaphylaxis during your infusion. You’ll also be monitored at this facility for at least 2 hours after your infusion is given. But, you may experience other symptoms of an allergic reaction for up to 24 hours after the infusion is complete.

If you develop symptoms of anaphylaxis, your doctor will immediately stop your Pemgarda infusion. But if you’ve had a previous severe allergic reaction to any ingredient in Pemgarda, your doctor will not prescribe it.

Other warnings

Pemgarda can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Pemgarda is a good treatment option for you.

Talk with your doctor about your health history before you take Pemgarda. Be sure to tell them if any of the following factors apply to you:

  • recently received a COVID-19 vaccine
  • have had recent contact with someone with COVID-19 infection
  • previous allergic reaction to any ingredient in Pemgarda
  • previous allergic reaction to any ingredient in a COVID-19 vaccine, including polysorbate 80 or polyethylene glycol (PEG)
  • pregnancy
  • breastfeeding

Whether you have health insurance or not, cost may be a factor when you’re considering Pemgarda. What you’ll pay for Pemgarda may depend on several things, such as your treatment plan and where you’ll receive infusions.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. A copay support program from the drugmaker for eligible people may be available soon. For updates on this program, check the drugmaker’s website.

You can also check out this article to learn more about saving money on prescriptions.

Disclaimer: Healthline 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.