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Safety & side effects
Information you should know about HYMPAVZI
HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist, and may increase the risk of thromboembolic complications.
HYMPAVZI may cause hypersensitivity reactions (including, but not limited to urticaria (hives) and pruritus (itching)). If you develop a hypersensitivity reaction during treatment with HYMPAVZI, stop using HYMPAVZI and get medical help right away.
HYMPAVZI may cause fetal harm when administered to a pregnant woman. Women who are able to bear children are advised to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose.
HYMPAVZI may cause hypersensitivity reactions (including, but not limited to urticaria (hives) and pruritus (itching)). If you develop a hypersensitivity reaction during treatment with HYMPAVZI, stop using HYMPAVZI and get medical help right away.
HYMPAVZI may cause fetal harm when administered to a pregnant woman. Women who are able to bear children are advised to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose.
The most common side effects reported in ≥3% of patients treated with HYMPAVZI were*:
- These were the most common side effects reported during the 12-month active treatment period of the phase 3 BASIS study. A serious adverse reaction of peripheral swelling occurred in one patient. HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist, and may increase the risk of thromboembolic complications. HYMPAVZI has not been studied in patients with a history of previous thromboembolic events.
Adverse Reactions (N=116)
Number of Patients, n (%)
Injection site reaction
11 (9)
Headache
8 (7)
Pruritus (itching)
4 (3)
HYMPAVZI may cause serious side effects, including:
- 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
- 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
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.
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.
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