IMPORTANT SAFETY INFORMATION & USE

Important: Before you start using HYMPAVZI, it is very important to talk to your healthcare provider about using factor VIII and factor IX products (products that help blood clot but work in a different way than HYMPAVZI). You may need to use factor VIII or factor IX medicines to treat episodes of breakthrough bleeding during treatment with HYMPAVZI. Carefully follow your healthcare provider’s instructions regarding when to use factor VIII or factor IX medicines and the prescribed dose during your treatment with HYMPAVZI.

Before using HYMPAVZI, tell your healthcare provider about all of your medical conditions, including if you:

1. have a planned surgery. Your healthcare provider may stop treatment with HYMPAVZI before your surgery. Talk to your healthcare provider about when to stop using HYMPAVZI and when to start it again if you have a planned surgery.
2. have a severe short-term (acute) illness such as an infection or injury.
3. are pregnant or plan to become pregnant. HYMPAVZI may harm your unborn baby.

• Females who are able to become pregnant:
  • Your healthcare provider will do a pregnancy test before you start your treatment with HYMPAVZI.
  • You should use effective birth control (contraception) during treatment with HYMPAVZI and for at least 2 months after the last dose of HYMPAVZI.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with HYMPAVZI.

1. are breastfeeding or plan to breastfeed. It is not known if HYMPAVZI passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over‑the‑counter medicines, vitamins, and herbal supplements.

What are the possible side effects of HYMPAVZI?

HYMPAVZI may cause serious side effects, including:

1. blood clots (thromboembolic events). HYMPAVZI may increase the risk for your blood to clot. Blood clots may form in blood vessels in your arm, leg, lung, or head and can be life‑threatening. Get medical help right away if you develop any of these signs or symptoms of blood clots:
   • swelling or pain in arms or legs
   • redness or discoloration in your arms or legs
   • shortness of breath
   • pain in chest or upper back
   • fast heart rate
   • cough up blood
   • feel faint
   • headache
   • numbness in your face
   • eye pain or swelling
   • trouble seeing
2. allergic reactions. Allergic reactions, including rash and itching have happened in people treated with HYMPAVZI. Stop using HYMPAVZI and get medical help right away if you develop any of the following symptoms of a severe allergic reaction:
   • swelling of your face, lips, mouth, or tongue
   • trouble breathing
   • wheezing
   • dizziness or fainting
   • fast heartbeat or pounding in your chest
   • sweating

The most common side effects of HYMPAVZI are injection site reactions, headache, and itching.

These are not all the possible side effects of HYMPAVZI. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What is HYMPAVZI?

HYMPAVZI is a prescription medicine used to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.

It is not known if HYMPAVZI is safe and effective in children younger than 12 years old.