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About HYMPAVZIAbout
HYMPAVZIOverviewHYMPAVZI in ActionEfficacyEfficacyStudy DesignPrimary EndpointsSecondary EndpointsSafetyDosing & AdminDosing 

& AdminDosingPen OverviewInjection OverviewPatient ProfilesPatient
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Full Prescribing InformationPatient InformationInstructions for UseIndication Patient Site
The efficacy and safety of HYMPAVZI were evaluated in the BASIS study, an open-label phase 3 studyThe efficacy and safety of HYMPAVZI were evaluated in the BASIS study, an open-label phase 3 study

Select participant inclusion criteria and select baseline patient characteristics1

Select participant inclusion criteria and select baseline patient characteristics1

Participant inclusion criteria1
  • Adult and adolescent males 12+ years of age and ≥35 kg (~77 lb) 
  • Severe hemophilia A without inhibitors or severe hemophilia B without inhibitors
    • Select exclusions: current treatment for/history of coronary artery disease, venous or arterial thrombosis, or ischemic disease
Baseline patient characteristics1
  • 116 adult and adolescent males
  • 1+ target joints: 100% of on-demand participants, 57% of routine prophylaxis participants
  • 3+ target joints: 36% of on-demand participants, 16% of routine prophylaxis participants
Select endpoints1PrimaryAnnualized bleed rate (ABR) of treated bleeds after 12 months of HYMPAVZI prophylaxis treatment vs:
  • On-demand factor-based treatment
  • Routine factor-based prophylaxis treatment
SecondaryAfter 12 months of treatment
  • Total bleeds
  • Spontaneous bleeds
  • Joint bleeds
  • Target joint bleeds
 Dosing schedule1* Bleed protection delivered

In the BASIS study, HYMPAVZI demonstrated reductions in ABR compared with on-demand factor-based treatment and routine factor-based prophylaxis treatment1†

 See efficacy data LoadingBleed protection delivered

In the BASIS study, HYMPAVZI demonstrated reductions in ABR compared with on-demand factor-based treatment and routine factor-based prophylaxis treatment1†

 See efficacy data LoadingA dose adjustment to 300 mg subcutaneous injection weekly can be considered in patients weighing ≥50 kg when control of bleeding events is judged to be inadequate by the healthcare provider. Safety and efficacy of HYMPAVZI at doses above 300 mg weekly have not been established.192% reduction in treated bleeds on HYMPAVZI compared to on-demand factor-based treatment (3.18 ABR vs 38.00 ABR). 35% reduction in treated bleeds on HYMPAVZI compared to routine factor-based prophylaxis treatment (5.08 ABR vs 7.85 ABR).1References:1. HYMPAVZI. Prescribing Information. Pfizer Inc.; 2024. 2. Data on file. Pfizer Inc.; 2024.Efficacy Bleed protection

Comparison of ABR of treated bleeds with HYMPAVZI vs on-demand factor-based treatment and routine factor-based prophylaxis treatment1

 See efficacy data Loading

HYMPAVZI is a trademark of Pfizer Inc.

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PP-HYM-USA-0073
Indications and usageHYMPAVZI 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.
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Important Safety InformationHYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist and may increase the risk of thromboembolic complications. 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.

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.

A serious adverse reaction of peripheral swelling occurred in one patient. Adverse reactions reported in ≥3% of patients treated with HYMPAVZI in clinical trials included injection site reaction (9% of patients); headache (7% of patients); pruritus (3% of patients).IndicationHYMPAVZI 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.