pemivibart 125 mg/mL intravenous solution (EUA)

Generic name:
Pemivibart - injection

Brand name(s)
Pemgarda

Pemivibart may cause serious (rarely fatal) allergic reactions that may happen during infusion and for some time afterward. Get medical help right away if you notice any signs of a serious allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain, or fast heartbeat. Your doctor may give you other medications to help with these side effects and may stop your treatment with this medication.

Pemivibart is a medication that the FDA is allowing to be given for emergency use to reduce the risk of getting COVID-19 infection in people who do not have COVID-19 and who have not been exposed to anyone with COVID-19. To receive this product, you must also have a weakened immune system because of certain conditions or medications (such as cancer, transplant), which reduces your response to the COVID-19 vaccine. It does not replace the COVID-19 vaccines. Talk to your doctor about the risks and benefits of treatment with pemivibart.

This medication belongs to a class of drugs known as monoclonal antibodies. It works by preventing the COVID-19 virus from entering the cells in the body. This effect may prevent COVID-19. More information about pemivibart is available from the FDA Fact Sheet for Patients, Parents, and Caregivers for Emergency Use provided by your health care professional. If you are enrolled in a study, information should be provided by the doctor via the Informed Consent Form.

There is limited information about how safe and effective pemivibart is for preventing COVID-19. This medication should not be used to treat COVID-19 or in people who have already been exposed to COVID-19.

The information in this document reflects emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of pemivibart, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.

This medication is given by slow injection into a vein as directed by your doctor. It is infused by a health care professional, usually over 60 minutes. If additional doses are needed, this medication may be given by a health care professional, every 3 months.

The number of doses you receive depends on your medical condition, new types of COVID-19 viruses (variants), and response to treatment.

If you received the COVID-19 vaccine, you should wait 2 weeks before receiving this medication.

Infusion reactions may happen during the infusion and for up to 24 hours afterward. Tell your doctor right away if you have any symptoms of infusion reactions such as fever, chills, muscle/joint pain, flushing, fast/irregular heartbeat, headache, or nausea. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

See also Warning and How to Use sections.

Pain, redness, swelling, or soreness may occur at the injection site. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Information is limited and it is unknown at this time if pemivibart causes other serious side effects. This is not necessarily a complete list of possible side effects.

Contact your doctor for medical advice about side effects.

Before using this medication, tell your doctor if you have any allergies. Pemivibart may contain inactive ingredients, which can cause allergic reactions or other problems.

Limited information is known at this time about other medical conditions that may affect how pemivibart works, or how pemivibart may affect other medical conditions.

Before using this medication, tell your doctor your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. Information is limited and it is unknown at this time if pemivibart has drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose information is not available at this time.

Not applicable.

Not applicable.

Not applicable. This medication is given in a hospital and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.