Pemivibart is an experimental medicine being studied for the prevention of COVID-19 before being exposed COVID-19. This drug is still being studied and all of its risks are not yet known.

Pemivibart does not replace vaccination against COVID-19.

COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.

COVID-19 can affect your lungs or other organs. Symptoms may be mild or serious and include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

The US Food and Drug Administration (FDA) has authorized emergency use of pemivibart for prevention of COVID-19 in certain adults and children at least 12 years of age who weigh at least 88 lbs (40 kg):

• who are not currently infected with COVID-19;
• who are not known to be exposed to someone infected with COVID-19;
• who have a weak immune system (due to a medical condition, certain medicines or treatment); and
• for whom other COVID-19 vaccination options will not work.

Your doctor will determine if you are able to receive pemivibart.

Pemivibart is not approved or authorized for use:

• to treat COVID-19; or
• if you are infected with COVID-19, are waiting for testing results, or are exposed to someone infected with COVID-19.

Pemivibart may also be used for purposes not listed in this medication guide.

You should not use pemivibart if you are allergic to it.

Tell your doctor if you have or ever had:

• received or scheduled to receive a vaccine;
• an allergic reaction to a COVID-19 vaccine or a previous dose of pemivibart;
• a serious illness or a weak immune system (caused by disease or by using certain medicine); or
• any allergies or other medical conditions.

You should not receive pemivibart if you have recently received a COVID-19 vaccine. You should wait at least 2 weeks after vaccination to receive pemivibart.

It is not known if pemivibart will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Pemivibart (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection and up to 24 hours after receiving pemivibart. Tell your medical caregivers if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, swelling in your face, flushing (sudden warmth, redness, or tingly feeling), ringing in your ears, or have fast heartbeats.

Your treatment may be permanently discontinued if you have certain side effects.

Common side effects may include:

• bruising, swelling, warmth, redness, oozing, or bleeding where the IV needle is placed;
• feeling unwell during the injection;
• flu-like symptoms, cold symptoms, viral infections;
• headache, tiredness; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.