Pfizer Hemophilia Connect 1-844-989-HEMO (4366)

Proven bleed protection with once-weekly dosing

Protection in patients using BeneFIX once weekly (median study results)†

(vs 34 with
on-demand treatment)
(vs 22 with
on-demand treatment)
(vs 29 with
on-demand treatment)
(vs 34 with on-demand treatment)
(vs 22 with on-demand treatment)
(vs 29 with on-demand treatment)
Demonstrated low median annualized bleeding rate (ABR)
In a clinical study, patients on BeneFIX once-weekly prophylaxis (100 IU/kg) had a lower median total ABR than patients treated on demand.

36% of patients in the study did not have any bleeds while on BeneFIX once-weekly prophylaxis.

The interquartile range (IQR) for the total ABR with once-weekly prophylaxis was 0.0 to 5.8. The IQR for the annualized spontaneous bleeding rate and ABR in joints with once-weekly prophylaxis was 0.0 to 2.9. The IQR represents the middle 50% of ABRs when ordered from lowest to highest.

†N=25.
‡Annualized spontaneous bleeding rate based on spontaneous bleeds unrelated to traumatic events.
STUDY DESCRIPTION

In a multicenter, open-label clinical trial, 25 previously treated patients (PTPs) were treated with BeneFIX administered at 100 IU/kg once weekly and evaluated for approximately 52 weeks. Common (≥5%) adverse reactions were headache (36%), fever (20%), and cough (8%).
In the study, no patients were withdrawn from the study due to an adverse reaction, no inhibitors were detected, and no thrombotic (blood clotting) events or anaphylactic events were reported.

Once-weekly safety

Low levels of inhibitors in BeneFIX clinical trials

The body can make antibodies called "inhibitors.” These may stop BeneFIX from working properly. The higher the level of inhibitors, the more they may block effective treatment with BeneFIX.

The strength of an inhibitor in a person's blood is measured in Bethesda units (BU).

  • High titer (more than 5 BU)

  • Low titer (less than 5 BU)

For once-weekly prophylaxis

In PTPs in a clinical trial:

developed an inhibitor with BeneFIX once weekly.

Patients included in the study had ≥100 exposure days to factor IX products and no current or past history of factor IX inhibitors prior to enrollment (N=25).

Not an actual patient.
Important Safety Information
  • BeneFix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
  • Call your health care provider right away if your bleeding is not controlled after using BeneFix.
  • Allergic reactions may occur with BeneFix. Call your health care provider or get emergency treatment right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, your lips and gums turning blue, fast heartbeat, facial swelling, faintness, rash, or hives.
  • Your body can make antibodies, called “inhibitors,” which may stop BeneFix from working properly.
  • If you have risk factors for developing blood clots, such as a venous catheter through which BeneFix is given by continuous infusion, BeneFix may increase the risk of abnormal blood clots. The safety and efficacy of BeneFix administration by continuous infusion have not been established.
  • Some common side effects of BeneFix are fever, cough, nausea, injection site reaction, injection site pain, headache, dizziness, and rash.
What Is BeneFix?

BeneFix, Coagulation Factor IX (Recombinant), is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Your doctor might also give you BeneFix before surgical procedures.

BeneFix is NOT used to treat hemophilia A.

Please see fullPrescribing Informationfor BeneFix.

Please see full Prescribing Information for BeneFIX.

Patients should always ask their doctors for medical advice about adverse events.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

Persons depicted throughout this website are not actual BeneFIX patients unless stated otherwise.

© 2024 Pfizer Inc. All rights reserved.

February 2024
PP-BEN-USA-0905

Pfizer logo

Important Safety Information and Indication

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Important Safety Information
  • BeneFix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
  • Call your health care provider right away if your bleeding is not controlled after using BeneFix.
  • Allergic reactions may occur with BeneFix. Call your health care provider or get emergency treatment right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, your lips and gums turning blue, fast heartbeat, facial swelling, faintness, rash, or hives.
  • Your body can make antibodies, called “inhibitors,” which may stop BeneFix from working properly.
  • If you have risk factors for developing blood clots, such as a venous catheter through which BeneFix is given by continuous infusion, BeneFix may increase the risk of abnormal blood clots. The safety and efficacy of BeneFix administration by continuous infusion have not been established.
  • Some common side effects of BeneFix are fever, cough, nausea, injection site reaction, injection site pain, headache, dizziness, and rash.
What Is BeneFix?

BeneFix, Coagulation Factor IX (Recombinant), is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Your doctor might also give you BeneFix before surgical procedures.

BeneFix is NOT used to treat hemophilia A.

Please see full Prescribing Information for BeneFix.

Patients should always ask their doctors for medical advice about adverse events.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit https://www.fda.gov/MedWatch or call 1-800-FDA-1088.

Persons depicted throughout this website are not actual BeneFix patients.

Copyright © 2023 Pfizer Inc. All rights reserved.

July 2023
PP-BENPP-BEN-USA-0829

Pfizer Logo