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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Thromboembolic Events: Thromboembolic events may occur. Interrupt HYMPAVZI prophylaxis if symptoms occur. ( 5.1 ) • Hypersensitivity: Hypersensitivity reactions may occur. In the event of a severe allergic reaction, discontinue HYMPAVZI. ( 5.2 ) • Embryofetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) 5.1 Thromboembolic Events HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist, and may increase the risk of thromboembolic complications. Venous thrombotic events were reported in clinical studies with HYMPAVZI [see Adverse Reactions (6.1) ] . Patients with independent risk factors for thromboembolic events may be at increased risk of thromboembolic events with use of HYMPAVZI. HYMPAVZI has not been studied in patients with a history of previous thromboembolic events [see Clinical Studies (14.1) ] . 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 [see Dosage and Administration (2.4) ] . 5.2 Hypersensitivity 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. 5.3 Embryofetal Toxicity 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) ] .
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Thromboembolic Events [see Warnings and Precautions (5.1) ] • Hypersensitivity [see Warnings and Precautions (5.2) ] Adverse reactions reported in ≥3% of HYMPAVZI-treated patients were injection site reaction, headache, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of HYMPAVZI was evaluated in adolescent and adult patients with severe hemophilia A or B without inhibitors (coagulation factor activity <1%) enrolled in the BASIS study [see Clinical Studies (14.1) ] . Patients (N = 116) received HYMPAVZI prophylaxis 300 mg loading dose followed by 150 mg every week starting at Day 8 administered subcutaneously. Among patients receiving HYMPAVZI, 97% were exposed for 6 months or longer and 75% were exposed for at least 1 year. A serious adverse reaction of peripheral swelling occurred in one patient. Table 1 summarizes the adverse reactions reported in ≥3% of patients who received HYMPAVZI prophylaxis. Table 1. Adverse Reactions Reported in ≥3% of Patients Treated with HYMPAVZI During BASIS trial 12-month active treatment phase Adverse Reaction Number of Patients n (%) (N = 116) Injection site reaction 11 (9) Headache 8 (7) Pruritus 4 (3) A serious adverse reaction of venous thrombosis occurred in 0.9% of patients (1/116) treated with HYMPAVZI in the open-label extension study [see Clinical Studies (14.1) ] .