HYMPAVZI
Generic: MARSTACIMAB-HNCQ
Basic Information
Manufacturer
Pfizer Laboratories Div Pfizer Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
a2cc631e-13a6-40c2-acf9-065ccedfb90a
Indications & Usage
1 INDICATIONS AND USAGE HYMPAVZI 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.
HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist 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.
( 1 )
HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist 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.
( 1 )
Adverse Reactions
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) ] .
( 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) ] .