Pemivibart

Pemivibart is an experimental medicine that is being studied to help prevent COVID-19 before exposure to the virus. The drug is still under investigation, and not all of its risks are known.

Pemivibart does not replace vaccination against COVID-19.

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

• who are not currently infected with COVID-19;
• have not had a known recent exposure to someone infected with COVID-19;
• 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 decide if you can receive pemivibart.

Pemivibart is not authorized for use:

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

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

The US Food and Drug Administration (FDA) has approved the emergency use of pemivibart to prevent COVID-19 in adults and children who are at least 12 years old and weigh at least 88 lbs (40 kg).

Some side effects may happen during or after the injection. Inform your medical caregiver immediately if you experience light-headedness, chest tightness, difficulty breathing, or swelling in your face.

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 medicines); 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 pemivibart.

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

Some side effects may happen during and after receiving the pemivibart injection. Tell your medical caregivers if you feel dizzy, nauseous, 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 stopped if you have certain side effects.

Common side effects of pemivibart may include:

• pain, bruising, swelling, warmth, redness, a possible infection, 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.

Pemivibart is given as one dose over 60 minutes as an infusion into a vein. A healthcare provider will give you this injection.

Tell your medical caregivers if you feel any burning or pain when pemivibart is injected.

You will be watched during and for at least 2 hours after the infusion to make sure you do not have a severe allergic reaction.

Your doctor will determine your treatment schedule. You may need to receive additional doses every 3 months for ongoing protection against COVID-19.

Pemivibart may not protect against all variants of COVID-19. Tell your doctor right away if you have signs or symptoms of COVID-19. You should also test for COVID-19 if this occurs.

Call your doctor for instructions if you miss your appointment for your pemivibart injection.

In a medical setting, an overdose would be treated quickly.

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

Other drugs may affect pemivibart, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.