Pemgarda

Pronunciation: pem-gard-a
Generic name: pemivibart
Dosage form: injection for intravenous infusion
Drug class: Miscellaneous antivirals

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2024.

What is Pemgarda?

Pemgarda (pemivibart) is an unapproved, injectable, antiviral, human monoclonal antibody that has received emergency use authorization (EUA) for the prevention of coronavirus disease 2019 (COVID-19) in high-risk immunocompromised adults and adolescents 12 years of age and older who weigh at least 40kg. Candidates:

Cannot be currently infected with SARS-CoV-2 or have had a known recent exposure to an individual infected with SARS-CoV-2

And

Must be moderately to severely immune compromised due to a medical condition (such as blood cancer) or receipt of immunosuppressive medications or treatments (such as an organ transplant) and be unlikely to mount an adequate immune response to COVID-19 vaccination.

Pemgarda (pemivibart) is an IgG1λ antibody that works by targeting the SARS-CoV-2 spike protein receptor binding domain (RBD), inhibiting the attachment of the SARS-CoV-2 virus to human ACE2 receptors, (these are the entry points of the virus into human cells). Pemgarda has been modified to extend how long it lasts in the body and activity has been reported for ancestral SARS-CoV-2 B.1 (D614G); Omicron variants BA.1, BA.2, and BA.4; XBB.1; EG.5.1; HV.1; and JN.1.

Pemgarda was issued an EUA on 22 March 2023. It is not FDA-approved for any use.

What are the side effects of Pemgarda?

Pemgarda may cause serious side effects, including:

Serious allergic reactions, that may be life-threatening, such as anaphylaxis. This can happen during or after your infusion. Tell your healthcare provider right away if you get any of the following signs or symptoms of anaphylaxis during or after your infusion of Pemgarda, such as itching, dizziness, flushing, ringing in the ears, hives, wheezing or trouble breathing, swelling of your face, lips, mouth, tongue, throat, hands, or feet, chest discomfort, sweating, or a fast heartbeat
Other allergic or infusion-related reactions. You may have an increased risk of allergic reaction with Pemgarda if you have had a severe allergic reaction to a COVID-19 vaccine. Tell your healthcare provider right away if you get any of the following signs or symptoms: fever, headache, trouble breathing or shortness of breath, throat tightness or irritation, chills, high or low blood pressure, tiredness, swelling, fast or slow heart rate, rash, including hives, chest pain or discomfort.

The side effects of receiving any medicine by vein (IV) may include pain, redness, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

The most common side effects reported in at least 2% of people treated with Pemgarda who have moderate-to-severe immune compromise include:

allergic and infusion-related reactions
infusion site reactions
common cold and other viral infections
flu-like illness, tiredness, or headache
nausea.

These are not all the possible side effects of Pemgarda, but not many people have been given Pemgarda, so it is possible that all of the risks are not known at this time. Serious and unexpected side effects may happen.

Tell your healthcare provider right away if you have any side effect that bothers you or does not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088, or call Invivyd at 1-800-890-3385.

Warnings and serious effects

Pemgarda carries a Black Box Warning for anaphylaxis, which can be life-threatening, and other hypersensitivity and infusion-related reactions. Anaphylaxis was reported in 0.6% (4 out of 623) of participants in a clinical trial, either during the first or second infusion of Pemgarda. You should only receive Pemgarda in a facility that has immediate access to medications to treat anaphylaxis and can activate the emergency medical system (EMS). You should be observed during the infusion and for at least 2 hours afterward. People who are allergic to pemivibart, Pemgarda, or any of the inactive ingredients in the infusion should not receive this medication.

Pemgarda contains polysorbate 80, which is used to stabilize aqueous formulations of injectable medications. This is also contained in some COVID-19 vaccines and is structurally similar to polyethylene glycol, an ingredient in other COVID-19 vaccines. If you have had a previous severe hypersensitivity reaction to a COVID-19 vaccine then consider talking to an allergist-immunologist before receiving Pemgarda.

Certain variants of the SARS-CoV-2 virus may emerge that are not neutralized by Pemgarda which means that it may not be effective at preventing COVID-19 caused by these variants. If you develop signs and symptoms of COVID-19, you should test for COVID-19 and seek medical attention.

Pemgarda is not authorized for use as a treatment for COVID-19 or for the prevention of COVID-19 in someone who has been exposed to a person already infected with COVID-19.

Pemgarda is not a substitute for vaccination in people for whom COVID-19 vaccination is recommended. People who have received a recent COVID-19 vaccination should wait at least 2 weeks before receiving it.

Before taking

Before taking Pemgarda, tell your healthcare provider about all of your medical conditions, including if you:

have any allergies, including if you have had a severe allergic reaction to a COVID-19 vaccine or Pemgarda, pemivibart, or any of the inactive ingredients in the infusion
have any serious illnesses
take any medicines including prescription, over-the-counter, vitamins, and herbal products
have recently had a COVID-19 vaccine
are pregnant or intend to become pregnant
are breastfeeding.

Pregnancy

It is not known if Pemgarda can harm your unborn baby. There is no experience using Pemgarda in women who are pregnant or breastfeeding. If you are pregnant discuss your options and specific situation with your healthcare provider.

Breastfeeding

It is not known if Pemgarda can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

How is Pemgarda administered?

Pemgarda is administered by a healthcare provider in a setting that can provide emergency treatment if necessary, in the unlikely event you may have a life-threatening allergic reaction.

Pemgarda is administered by an intravenous (IV) infusion into your vein over at least 60 minutes.
The usual dosage for adults and adolescents (12 years of age and older weighing at least 40 kg) is 4500 mg administered as a single intravenous infusion.
You may need to receive additional doses of Pemgarda for ongoing protection from COVID-19 approximately every 3 months.

Your healthcare provider will monitor you for allergic reactions during your infusion and for at least 2 hours after you are finished the infusion.

Your healthcare provider will stop the infusion right away if you develop signs or symptoms of anaphylaxis or a severe allergic reaction.
Tell your healthcare provider right away if you get any signs or symptoms of anaphylaxis during or hours to days after your infusion (see side effects below).

What other important information do I need to know when receiving Pemgarda?

Viruses can change over time (mutate) and develop into a slightly different form of the virus, called a variant. Pemgarda may not be effective at preventing COVID-19 caused by certain SARS-CoV-2 variants. Tell your healthcare provider right away, and test for COVID-19, if you develop any symptoms of COVID-19, including:

fever or chills
headache
cough
sore throat shortness of breath or difficulty breathing
new loss of taste or smell
congestion or runny nose
feeling tired (fatigue)
nausea or vomiting
muscle or body aches
diarrhea.

What other drugs will affect Pemgarda?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Pemgarda with certain other medicines may affect how each medicine works or increase the risk of side effects. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Pemgarda should be stored in the refrigerator and allowed to warm to room temperature (18°C to 26°C [64°F to 79°F]) for 10 minutes before preparation.

Do not expose to direct heat. Do not shake.

Pemgarda ingredients

Active ingredient: pemivibart

Inactive ingredients: glycine, L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, and sterile water for injection.

Supplied as a 500 mg/4 mL (125 mg/mL) injection in a single-dose vial.