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About HYMPAVZIAbout
HYMPAVZIOverviewHYMPAVZI in ActionEfficacyEfficacyStudy DesignPrimary EndpointsSecondary EndpointsSafetyDosing & AdminDosing 

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Safety demonstrated in the BASIS study1Safety demonstrated in the BASIS study1A majority of adverse reactions were mild to moderate2*BASIS study N=116. Adverse reactions reported in ≥3% of patients treated with HYMPAVZI1
Adverse Reactions (N=116) Number of Patients, n (%)
Injection site reaction 11 (9)
Headache 8 (7)
Pruritus 4 (3)
One patient experienced headache that was assessed as severe.2
A serious adverse reaction of peripheral swelling occurred in one patient.1

In the BASIS study, there were no reported discontinuations due to adverse reactions.2†
See PI for guidance on when to discontinue HYMPAVZI.1 

See Important Safety Information for a full list of Warnings and Precautions.

Treatment related.Prefilled pen. Fixed dose.‡ 

Once weekly1

Dosing that may fit your patients' individual lifestyles

 See dosing LoadingPrefilled pen. Fixed dose.‡ 
Once weekly1

Dosing that may fit your patients' individual lifestyles

 See dosing LoadingThe recommended dosage of HYMPAVZI on day 1 is a loading dose of 300 mg (two 150 mg pens) by subcutaneous injection. On day 8 and thereafter, the weekly maintenance dose is 150 mg (one pen) by subcutaneous injection. A 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.1References:1. HYMPAVZI. Prescribing Information. Pfizer Inc.; 2024. 2. Data on file. Pfizer Inc.; 2024.Safety Prefilled pen. Fixed dose.‡ Once weekly1

Dosing that may fit your patients' individual lifestyles

 See dosing Loading

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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.