Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Información selecta para pacientes y cuidadores que se encuentra disponible en Español.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our medical information is accurate, up to date, and scientifically balanced.

BENEFIX®(Coagulation Factor IX (Recombinant))

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our medical information is accurate, up to date, and scientifically balanced.

BENEFIX® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
Did you find an answer to your question? Yes No

1 INDICATIONS AND USAGE

BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with...

Did you find an answer to your question? Yes No

2 DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution only.

  • Each vial of BeneFIX has the recombinant Factor IX (rFIX) potency in the International Units (IU)...
Did you find an answer to your question? Yes No

3 DOSAGE FORMS AND STRENGTHS

BeneFIX is supplied as a white lyophilized powder in the following nominal dosages:

  • 250 IU
  • 500 IU
  • 1000 IU
  • 2000 IU
  • 3000 IU

Each...

Did you find an answer to your question? Yes No

4 CONTRAINDICATIONS

BeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.

...
Did you find an answer to your question? Yes No

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported with BeneFIX and have manifested as...

Did you find an answer to your question? Yes No

6 ADVERSE REACTIONS

The most serious adverse reactions are systemic hypersensitivity reactions, including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating...

Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no data with...

Did you find an answer to your question? Yes No

11 DESCRIPTION

BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be...

Did you find an answer to your question? Yes No

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

BeneFIX temporarily replaces the missing clotting factor IX that is needed for effective hemostasis.

...
Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

BeneFIX has been shown to be nonmutagenic in the Ames assay and non-clastogenic in...

Did you find an answer to your question? Yes No

14 CLINICAL STUDIES

Efficacy of BeneFIX has been evaluated in clinical trials in which a total of 153 subjects received BeneFIX either for the on-demand treatment and control of bleeding episodes, perioperative management,...

Did you find an answer to your question? Yes No

15 REFERENCES

  1. Roberts HR, Eberst ME. Current management of hemophilia B. Hematol Oncol Clin North Am. 1993;7(6):1269–1280.
  2. Shapiro AD, Ragni MV, Lusher JM, et al. Safety and efficacy of monoclonal...
Did you find an answer to your question? Yes No

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

BeneFIX, Coagulation Factor IX (Recombinant), is supplied in kits that include single-...

Did you find an answer to your question? Yes No

17 PATIENT COUNSELING INFORMATION

  • Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
  • Allergic-type hypersensitivity reactions are possible. Inform patients of the early...
Did you find an answer to your question? Yes No

Instructions for Use

BeneFIX® / BEN-uh-fiks/

[Coagulation Factor IX (Recombinant)]

BeneFIX is supplied as a powder. Before it can be...

Did you find an answer to your question? Yes No

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Did you find an answer to your question? Yes No
Did you find an answer to your question? Yes No

Resources

Pfizer Factor Savings Card
For questions regarding the Pfizer Factor Savings Card, please call (888) 240-9040
Didn’t find what you were looking for? Contact us.
Report Adverse Event