Pemivibart injection

Pemivibart injection is currently being studied for the prevention of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.

Only limited clinical trial information is available at this time to support the use of pemivibart injection for the prevention of COVID-19. More information is needed to know how well the pemivibart works for the prevention of COVID-19 and the possible adverse events from it.

Pemivibart has been associated with hypersensitivity (severe allergic) reactions, including anaphylaxis, during the first or second infusions. Your doctor or nurse will monitor you very closely during your infusion and for 2 hours after. If you experience any of the following symptoms, tell your doctor immediately or seek emergency medical care: headache; nausea; vomiting; diarrhea; stomach pain; swelling of your face, lips, tongue, or throat; rash; hives; itching; fever; chills; dizziness; weakness; difficulty breathing; fast or irregular heartbeat; or chest pain.

Pemivibart is used to prevent COVID-19 in people 12 years of age and older who weigh at least 88 pounds (40 kg) and who are not currently infected with the SARS-CoV-2 virus and who have not had recent exposure to an individual infected with the SARS-CoV-2 virus and are immunocompromised (have a weakened immune system) due to a medical condition or being on certain medicines which may cause them not to respond to a COVID-19 vaccine.

Pemivibart is in a class of medications called monoclonal antibodies. It works by preventing the virus from entering and infecting human cells.

Pemivibart injection comes as a solution (liquid) to be injected intravenously (into the vein) by a doctor or a nurse in a medical clinic or in an office. It is usually given every 3 months. Your doctor will decide how long you should receive pemivibart.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving pemivibart injection,

• tell your doctor and pharmacist if you are allergic to pemivibart, COVID-19 vaccines, polysorbate 80, polyethylene glycol, any other medications, or any of the ingredients in pemivibart injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving pemivibart, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Pemivibart may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• cough, nasal congestion, runny nose, sneezing, fever, and shortness of breath
• fatigue
• headache
• nausea

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• brain fog
• dry, itchy skin or redness of skin
• muscle aches or pains
• tingling, burning or numbness of skin

Pemivibart injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor. If you miss an appointment to receive pemivibart, call your doctor right away.

Ask your pharmacist any questions you have about pemivibart injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Pemgarda^®