Important Safety Information Expand

What is the most important information I should know about PEMGARDA?

PEMGARDA may cause serious side effects, including:

  • A serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and can happen during or after your infusion of PEMGARDA. In case you have a severe allergic reaction to PEMGARDA and need medical help right away, you will receive PEMGARDA in a healthcare setting. Your healthcare provider will monitor you for allergic reactions during your infusion and for at least 2 hours after you are finished receiving PEMGARDA. Your healthcare provider will stop PEMGARDA right away if you develop signs or symptoms of anaphylaxis or severe allergic reaction. Tell your healthcare provider right away if you get any of the following signs or symptoms of anaphylaxis during or after your infusion of PEMGARDA:
  • itching
  • flushing
  • hives
  • skin redness
  • swelling of your face, lips, mouth, tongue, throat, hands, or feet
  • sweating
  • dizziness
  • ringing in the ears
  • wheezing
  • trouble breathing
  • chest discomfort
  • fast heartbeat

What is PEMGARDA?

PEMGARDA is an investigational medicine that is used for pre-exposure prophylaxis to help prevent COVID-19 in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) who:

  • are not currently infected with SARS-CoV-2 and who have not been known to be exposed to someone who is infected with SARS-CoV-2 and
  • have moderate-to-severe immune compromise because of a medical condition or because they receive medicines or treatments that suppress the immune system and they are unlikely to have an adequate response to COVID-19 vaccination.

What should I tell my healthcare provider before I receive PEMGARDA?

Tell your healthcare provider about all of your medical conditions, including if you:

  • have any allergies, including if you have had a severe allergic reaction to a COVID-19 vaccine or PEMGARDA.
  • are pregnant or plan to become pregnant. It is not known if PEMGARDA can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if PEMGARDA can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive PEMGARDA.
  • have any serious illnesses.
  • take any medicines, including prescription, over-the-counter, vitamins, and herbal products.

Who should generally not take PEMGARDA?

Do not take PEMGARDA if you have had a severe allergic reaction to PEMGARDA or any ingredient in PEMGARDA.

What are the important possible side effects of PEMGARDA?

  • See “What is the most important information I should know about PEMGARDA?”
  • Allergic and infusion-related reactions: Allergic and infusion-related reactions are common and can sometimes be severe or life-threatening. Allergic and infusion-related reactions can happen during and after your infusion of PEMGARDA. You may have an increased risk of allergic reaction with PEMGARDA if you have had a severe allergic reaction to a COVID-19 vaccine. Your healthcare provider will monitor you for 2 hours after you receive PEMGARDA.

Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic or infusion-related reaction during or after your infusion of PEMGARDA:

  • fever
  • trouble breathing or shortness of breath
  • chills
  • tiredness
  • fast or slow heart rate
  • chest pain or discomfort
  • weakness
  • confusion
  • nausea
  • headache
  • throat tightness or irritation
  • high or low blood pressure
  • swelling of your face, lips, mouth, tongue, throat, hands, or feet
  • rash, including hives
  • itching
  • muscle aches
  • feeling lightheaded, faint, or dizzy
  • sweating

The side effects of receiving any medicine by vein (IV) may include pain, redness, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

The most common side effects in people treated with PEMGARDA who have moderate-to-severe immune compromise include allergic and infusion-related reactions, infusion site reactions, common cold, viral infection, flu-like illness, tiredness, headache, and nausea.

Please read the accompanying Fact Sheet for Patients, Parents and Caregivers for more information.