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PP-HYM-USA-0763
Indications and usageHYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
 
  • hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or
  • hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.
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Important Safety InformationVenous thrombotic events were reported in clinical studies with HYMPAVZI. Patients with independent risk factors for thromboembolic events may be at increased risk of thromboembolic events with use of HYMPAVZI. Consider the benefit and risk of using HYMPAVZI in patients with known risk factors for thromboembolism. Interrupt HYMPAVZI prophylaxis if diagnostic findings consistent with thromboembolism occur and manage as clinically indicated. If factor VIII or factor IX products are indicated in a patient receiving HYMPAVZI prophylaxis, the minimum effective dose of factor VIII or factor IX according to the product label is recommended.

HYMPAVZI may cause hypersensitivity reactions (including, but not limited to, urticaria and pruritus). If HYMPAVZI-treated patients develop a severe hypersensitivity reaction, advise patients to discontinue HYMPAVZI and seek immediate emergency treatment.

Based on its mechanism of action, HYMPAVZI may cause fetal harm when administered to a pregnant woman. Verify that females of reproductive potential are not pregnant prior to initiating HYMPAVZI. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose.

A serious adverse reaction of peripheral swelling occurred in one patient. A serious adverse reaction of venous thrombosis occurred in 0.9% of patients (1/116) in the open-label extension study. Adverse reactions reported in ≥3% of patients treated with HYMPAVZI in clinical trials included injection site reaction (9% of patients); headache (7% of patients); pruritus (3% of patients).
IndicationsHYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
  • hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or
  • hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.