Pemivibart (Intravenous)
Pemivibart is an experimental medicine being studied for the prevention of COVID-19 before being exposed to 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.
The US Food and Drug Administration (FDA) has authorized emergency use of pemivibart for prevention of COVID-19 in adults and children at least 12 years of age who 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 determine if you are able to 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 are exposed to someone infected with COVID-19.
Pemivibart may also be used for purposes not listed in this medication guide.
uses
What is Pemivibart (Intravenous) used for?
- Pre-Exposure Prophylaxis
warnings
What is the most important information I should know about Pemivibart (Intravenous)?
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 this medicine.
Side Effects
What are the side effects of Pemivibart (Intravenous)?
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 and after receiving the pemivibart injection. 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:
- 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.
Pregnancy & Breastfeeding
Can I take Pemivibart (Intravenous) if I’m pregnant or breastfeeding?
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.
Interactions
What drugs and food should I avoid while taking Pemivibart (Intravenous)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Pemivibart (Intravenous)?
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.
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 an appointment for your pemivibart injection.
Overdose Signs
What happens if I overdose on Pemivibart (Intravenous)?
In a medical setting an overdose would be treated quickly.