Not actual patients.
Safety and side effects
Safety and side effects from clinical studies of HYMPAVZI
HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist and may increase the risk of thromboembolic complications.
Venous and arterial thromboembolic events (blood clots) were reported in clinical studies with HYMPAVZI. People taking HYMPAVZI who receive other bleeding-control treatments before, during, or after surgery may have a higher risk of blood clots.
Venous and arterial thromboembolic events were reported in 0.8% of patients (2/259) treated with HYMPAVZI in the open-label extension (OLE) study. An OLE is a long-term study that continues to observe and measure the long-term safety, tolerability, and/or effectiveness of the drug from the original clinical study.
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.
From the BASIS and BASIS KIDS clinical studies: The safety of HYMPAVZI was evaluated in adults and children 6 years of age and older with hemophilia A or B, with or without inhibitors, enrolled in the BASIS and BASIS KIDS studies. A total of 259 patients received the recommended HYMPAVZI prophylaxis loading dose, followed by a weekly maintenance dose starting at Day 8.
The most common side effects reported in ≥2% of hemophilia patients treated with HYMPAVZI were*:
- During BASIS and BASIS KIDS studies 12-month active treatment phase.
- †Injection site reaction is a grouped term which includes the following terms: injection site pruritus, injection site swelling, injection site erythema, injection site bruising, injection site induration, injection site pain, injection site edema, injection site hematoma, injection site hemorrhage, injection site warmth, and injection site urticaria.
- ‡Headache is a grouped term which includes migraine.
Additional safety information to know
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, which 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 your 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
- feeling 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.
