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 [see Clinical Studies (14.1)]. 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 [see Dosage and Administration (2.4)].
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 [see Clinical Pharmacology (12.1)]. 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 [see Use in Specific Populations (8.1, 8.3)].
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 [see Clinical Studies (14.1)]. 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 [see Dosage and Administration (2.4)].
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 [see Clinical Pharmacology (12.1)]. 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 [see Use in Specific Populations (8.1, 8.3)].
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