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

Proven bleed control

Demonstrated bleed control in previously untreated patients (PUPs)

Indicated for bleed control in PUPs

94.1% of responses were rated excellent or good in PUPs receiving an initial infusion of BeneFix for on-demand treatment

  • 2.9% of responses were rated moderate, 1% of responses were rated no response, 2% were not rated
  • 1505 infusions were given for on-demand treatment of 997 hemorrhages
  • All bleeding episodes were controlled

75% of bleeds were controlled after 1 infusion with BeneFix

  • 14.9% were controlled after 2 infusions
  • 5.4% were controlled after 3 infusions
  • 2.4% were controlled after 4 infusions
  • 2.2% were controlled after >4 infusions

Study included 54 evaluable patients; median dose 62.7 IU/kg (range: 8.2-292 IU/kg).

Bleed control rating scale: efficacy was rated by the caregiver or investigator using a 4-point scale, based on a comparison with previously used plasma-derived factor IX (pdFIX) products for similar bleeds or procedures: excellent (as much and as rapid an improvement as the best pdFIX-related responses), good (as much and as rapid an improvement as most pdFIX-related responses), moderate (not as good as most pdFIX-related responses), or no response (no improvement).

STUDY DESCRIPTION
In a multicenter, open-label clinical trial, 25 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 (8.0%). In the study, no patients were withdrawn from the study due to an adverse reaction, no inhibitors were detected, and no thrombotic (blood clotting) events or anaphylactic events were reported.

Experience with PTPs

Indicated for bleed control§ in PTPs

90.9% of responses were rated excellent or good in PTPs receiving an initial infusion of BeneFIX for on-demand treatment

  • 7.1% were rated as moderate, 0.7% were rated as no response, 1.3% were not rated||
  • 2758 infusions were given for on-demand treatment of 1796 hemorrhages
  • All bleeding episodes were controlled

80.9% of bleeds were controlled after 1 infusion with BeneFIX

  • 11.6% were controlled after 2 infusions
  • 3.6% were controlled after 3 infusions
  • 1.8% were controlled after 4 infusions
  • 2.1% were controlled after >4 infusions

In the same study, 63% of PTPs did not have spontaneous bleeding within 48 hours of their last infusion.

§Study included 55 evaluable patients; median dose 42.8 IU/kg (range: 6.5-224.6 IU/kg).

||Bleed control rating scale: efficacy was rated by the patient or investigator using a 4-point scale, based on a comparison with previously used pdFIX products for similar bleeds or procedures: excellent (as much and as rapid an improvement as the best pdFIX-related responses), good (as much and as rapid an improvement as most pdFIX-related responses), moderate (not as good as most pdFIX-related responses), or no response (no improvement).

Study included 19 evaluable patients; mean dose 40.3 IU/kg (range: 13-78 IU/kg).

STUDY DESCRIPTION
A 20-center international trial was conducted in 56 PTPs with severe or moderate (<5 IU/dL factor IX activity) hemophilia B. Participants received recombinant factor IX (rFIX) for pharmacokinetic studies, treatment of or prophylaxis against hemorrhage, or surgical hemostasis (for all interventions the regimen was prescribed by the investigator) for a mean duration of treatment of 23.4 ± 5.3 months and were assessed at 3-month intervals for 2 years. This research was originally published in Blood.

On-demand 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 BU.

  • High titer (more than 5 BU)
  • Low titer (less than 5 BU)

For on-demand treatment

Up nextDosing and R2 Kit
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 © 2021 Pfizer Inc. All rights reserved.

June 2021
PP-BEN-USA-0498

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 © 2021 Pfizer Inc. All rights reserved.

June 2021
PP-BEN-USA-0498

Pfizer Logo