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About HYMPAVZIAbout
HYMPAVZIOverviewHYMPAVZI in ActionEfficacyEfficacyStudy DesignPrimary EndpointsSecondary EndpointsSafetyDosing & AdminDosing 

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HYMPAVZI (marstacimab-hncq) safety profile

BASIS and BASIS KIDS Study Safety

BASIS and OLE Study Safety

BASIS KIDS Study Safety

Tab Number 4

Tab Number 5

Ages 6+: Safety demonstrated in the BASIS and BASIS KIDS studies1

The safety of HYMPAVZI was evaluated in adults and children 6 years of age and older with hemophilia A or B with or without inhibitors enrolled in the BASIS and BASIS KIDS studies. A total of 259 patients received the recommended HYMPAVZI prophylaxis loading dose followed by a weekly maintenance dose starting at day 8.1

A majority of adverse reactions were mild to moderate2

Adverse reactions reported in ≥2% of hemophilia patients ages 6 and older, treated with HYMPAVZI1*

  Adverse Reactions   Number of Patients, n (%)
  (N=259)
  Injection site reaction†   30 (12%)
  Headache‡   19 (7%)
  Pyrexia   15 (6%)
  Arthralgia   9 (3%)
  Diarrhea   7 (3%)
  Pruritus   6 (2%)
  Rash   5 (2%)
Adverse Reactions Number of Patients, n (%)
(N=259)
Injection site reaction† 30 (12%)
Headache‡ 19 (7%)
Pyrexia 15 (6%)
Arthralgia 9 (3%)
Diarrhea 7 (3%)
Pruritus 6 (2%)
Rash 5 (2%)

Venous and arterial thromboembolic events were reported in 0.8% of patients (2/259) treated with HYMPAVZI in the open-label extension study. Patients with independent risk factors for thromboembolic events may be at increased risk of thromboembolic events with use of HYMPAVZI.1

See PI for guidance on when to discontinue HYMPAVZI.1
See Important Safety Information for a full list of Warnings and Precautions.

See Dosing & Admin
Loading See Dosing & Admin Loading

Meet Peter, a real HYMPAVZI patient without inhibitors

Hear Peter’s experience using once-weekly HYMPAVZI1

 See Peter’s storyLoadingABR=annualized bleed rate; OLE=open-label extension.During the BASIS and BASIS KIDS studies’ 12-month active treatment phase.1Injection site reaction is a grouped term which includes the following terms: injection site pruritus, injection site swelling, injection site erythema, injection site bruising, injection site induration, injection site pain, injection site edema, injection site hematoma, injection site hemorrhage, injection site warmth, and injection site urticaria.1Headache is a grouped term which includes migraine.1The BASIS and BASIS KIDS studies’ safety includes adverse reactions for greater than or equal to 2% for patients ages 6+. The table above shows adverse reactions for patients ages 6 to <18.1For children ages 6 to <12, the recommended loading dose is 150 mg on day 1, then 75 mg weekly maintenance dose starting day 8. For adults and adolescents ages 12+, the recommended loading dose is 300 mg on day 1, then 150 mg weekly maintenance dose starting day 8. When control of bleeding events is judged to be inadequate, dose adjustment may be considered.1
Ages 12+ without inhibitors: Safety observed in the BASIS study and OLE study1,2OLE study limitations1,2

The OLE study is an ongoing observational study in which no formal hypothesis testing was conducted. The study’s design is not intended to support conclusions about efficacy and safety. Not all HYMPAVZI patients in the BASIS study rolled over into the OLE study.

  • The ABR calculation includes patients receiving either 150 mg or 300 mg of HYMPAVZI weekly
  • Enrollment in OLE studies may favorably select patients who are responsive to HYMPAVZI treatment
  • Results should be interpreted with caution as they may represent chance findings

Adverse reactions reported in ≥2% of hemophilia patients ages 12+ (without inhibitors) treated with HYMPAVZI in the BASIS study and in the ongoing OLE study (data as of April 13, 2024)2

  Adverse Reactions   Number of Patients, n (%)
  (N=116)
  Injection site reaction   15 (13%)
  Headache   11 (10%)
  Arthralgia   8 (7%)
  Pruritus   4 (3%)
  Rash   4 (3%)
  Pyrexia   3 (3%)
  Adverse Reactions   Number of Patients, n (%)
  (N=116)
Injection site reaction 15 (13%)
Headache 11 (10%)
Arthralgia 8 (7%)
Pruritus 4 (3%)
Rash 4 (3%)
Pyrexia 3 (3%)

Venous and arterial thromboembolic events were reported in 0.8% of patients (2/259) treated with HYMPAVZI in the open-label extension study. Patients with independent risk factors for thromboembolic events may be at increased risk of thromboembolic events with use of HYMPAVZI.1

See PI for guidance on when to discontinue HYMPAVZI.1
See Important Safety Information for a full list of Warnings and Precautions.

See Dosing & Admin
Loading See Dosing & Admin Loading

Meet Peter, a real HYMPAVZI patient without inhibitors

Hear Peter’s experience using once-weekly HYMPAVZI1

 See Peter’s storyLoadingABR=annualized bleed rate; OLE=open-label extension.During the BASIS and BASIS KIDS studies’ 12-month active treatment phase.1Injection site reaction is a grouped term which includes the following terms: injection site pruritus, injection site swelling, injection site erythema, injection site bruising, injection site induration, injection site pain, injection site edema, injection site hematoma, injection site hemorrhage, injection site warmth, and injection site urticaria.1 Headache is a grouped term which includes migraine.1​​​​​​​ The BASIS and BASIS KIDS studies’ safety includes adverse reactions for greater than or equal to 2% for patients ages 6+. The table above shows adverse reactions for patients ages 6 to <18.1For children ages 6 to <12, the recommended loading dose is 150 mg on day 1, then 75 mg weekly maintenance dose starting day 8. For adults and adolescents ages 12+, the recommended loading dose is 300 mg on day 1, then 150 mg weekly maintenance dose starting day 8. When control of bleeding events is judged to be inadequate, dose adjustment may be considered.1
Ages 6 to <18: Safety observed in BASIS and BASIS KIDS studies1

A majority of adverse reactions were mild to moderate2

Adverse reactions reported in ≥2% of hemophilia patients, 6 to <18, treated with HYMPAVZI1*

  Adverse Reactions   Number of Patients
  6 to <18, n (%) (N=124)
  Injection site reaction†   19 (15%)
  Headache‡   9 (7%)
  Pyrexia   12 (10%)
  Arthralgia   4 (3%)
  Diarrhea   5 (4%)
  Pruritus§   1 (1%)
  Rash   2 (2%)
  Adverse Reactions   Number of Patients
  6 to <18, n (%) (N=124)
Injection site reaction† 19 (15%)
Headache‡ 9 (7%)
Pyrexia 12 (10%)
Arthralgia 4 (3%)
Diarrhea 5 (4%)
Pruritus§ 1 (1%)
Rash 2 (2%)

Venous and arterial thromboembolic events were reported in 0.8% of patients (2/259) treated with HYMPAVZI in the open-label extension study. Patients with independent risk factors for thromboembolic events may be at increased risk of thromboembolic events with use of HYMPAVZI.1

See PI for guidance on when to discontinue HYMPAVZI.1
See Important Safety Information for a full list of Warnings and Precautions.

See Dosing & Admin
Loading See Dosing & Admin Loading

Meet Peter, a real HYMPAVZI patient without inhibitors

Hear Peter’s experience using once-weekly HYMPAVZI1

 See Peter’s storyLoadingABR=annualized bleed rate; OLE=open-label extension.During the BASIS and BASIS KIDS studies’ 12-month active treatment phase.1Injection site reaction is a grouped term which includes the following terms: injection site pruritus, injection site swelling, injection site erythema, injection site bruising, injection site induration, injection site pain, injection site edema, injection site hematoma, injection site hemorrhage, injection site warmth, and injection site urticaria.1Headache is a grouped term which includes migraine.1The BASIS and BASIS KIDS studies’ safety includes adverse reactions for greater than or equal to 2% for patients ages 6+. The table above shows adverse reactions for patients ages 6 to <18.1For children ages 6 to <12, the recommended loading dose is 150 mg on day 1, then 75 mg weekly maintenance dose starting day 8. For adults and adolescents ages 12+, the recommended loading dose is 300 mg on day 1, then 150 mg weekly maintenance dose starting day 8. When control of bleeding events is judged to be inadequate, dose adjustment may be considered.1
References:1. HYMPAVZI. Prescribing Information. Pfizer Inc.; 2026. 2. Data on file. Pfizer Inc.; 2025.Safety

Prefilled pen. Fixed dose. Once weekly1

Designed with convenience in mind

 See dosing Loading

HYMPAVZI is a registered trademark of Pfizer Inc.

To report an adverse event, please call 1‑800‑438‑1985

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This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

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PP-HYM-USA-1460
Indications and usageHYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with:
  • hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or
  • hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors.
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Important Safety InformationHYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist, and may increase the risk of thromboembolic complications. Venous and arterial thromboembolic events were reported in 0.8% of patients (2/259) in the open-label extension study. 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 or bypassing agents are indicated in a patient receiving HYMPAVZI prophylaxis, the minimum effective dose according to the product label is recommended. Inform patients of signs and symptoms of thromboembolic events. Monitor patients for thromboembolic events.

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.

HYMPAVZI can cause increased levels of fibrin D-dimer and prothrombin fragment 1.2. For patients taking HYMPAVZI, these coagulation biomarkers may not be reliable predictive markers for clinical decision-making with suspicion of thrombosis such as deep vein thrombosis (DVT) and pulmonary embolism (PE).

Adverse reactions reported in ≥2% of patients treated with HYMPAVZI in clinical trials in adult and pediatric patients 6 years and older with hemophilia A or B with or without inhibitors included injection site reaction (12%); headache, including headache and migraine (7%); pyrexia (6%); arthralgia (3%); diarrhea (3%); pruritus (2%); rash (2%).

Consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.IndicationsHYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with:
  • hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or
  • hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors.