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BENEFIX®(Coagulation Factor IX (Recombinant))
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
BENEFIX® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
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- Each vial of BeneFIX has the recombinant Factor IX (rFIX) potency in the International Units (IU)...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
BeneFIX is supplied as a white lyophilized powder in the following nominal dosages:
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- 250 IU
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- 500 IU
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- 1000 IU
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- 2000 IU ...
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Contraindications
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.
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, have been reported with BeneFIX and have manifested as...
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Adverse Reactions
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...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no data with...
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Description
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...
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Clinical Pharmacology
...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
BeneFIX temporarily replaces the missing clotting factor IX that is needed for effective hemostasis.
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Nonclinical Toxicology
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...
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Clinical Studies
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,...
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References
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...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
BeneFIX, Coagulation Factor IX (Recombinant), is supplied in kits that include single-...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
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- Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
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- Allergic-type hypersensitivity reactions are possible. Inform...
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Instructions For Use
Instructions for Use
BeneFIX® / BEN-uh-fiks/
[Coagulation Factor IX (Recombinant)]
BeneFIX is supplied as a powder. Before it can be...
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Other
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For Medical...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.