The following clinically significant adverse reactions are described elsewhere in the labeling:
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.
| |
Adverse Reaction | Number of Patients n (%) (N = 116) |
Injection site reaction | 11 (9) |
Headache | 8 (7) |
Pruritus | 4 (3) |
The following clinically significant adverse reactions are described elsewhere in the labeling:
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.
| |
Adverse Reaction | Number of Patients n (%) (N = 116) |
Injection site reaction | 11 (9) |
Headache | 8 (7) |
Pruritus | 4 (3) |
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