ASH Clinical News December 2015 | Page 81

YOUR EXPERIENCE.
THE DECIDING FACTOR.

BeneFIX—the recombinant factor IX you’ve
turned to for more than 18 years*
• Demonstrated bleed control across a wide range of patients2†
• An established safety profile in previously untreated and previously
treated patients2
• An all-inclusive Rapid Reconstitution (R2) Kit provides reconstitution
convenience for your patients’ busy lives
• Expertise in third-generation recombinant technology with
sustained supply from Pfizer3-5

Stick with the most prescribed recombinant factor IX for hemophilia B6

• Neutralizing antibodies (inhibitors) have been
reported following the administration of BeneFIX.
If expected plasma factor IX activity levels are not
attained, or if the patient presents with an allergic
reaction, or if bleeding is not controlled following
an expected dose of BeneFIX, perform an assay that
measures factor IX inhibitor concentration.

Please see brief summary of Full Prescribing
Information on next page.
REFERENCES: 1. Center for Biologics Evaluation and Research, US Food and
Drug Administration, US Department of Health and Human Services. CBER
Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/Approved
Products/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.
htm. Published February 11, 1997. Accessed April 9, 2013. 2. BeneFIX®
Coagulation Factor IX (Recombinant) [Prescribing Information]. Philadelphia,
PA: Wyeth Pharmaceuticals Inc; 8.2015. 3. Adamson S, Charlebois T,
O’Connell B, Foster W. Viral safety of recombinant factor IX. Semin Hematol.
1998;35(suppl 2):22-27. 4. Harrison S, Adamson S, Bonam D, et al. The
manufacturing process for recombinant factor IX. Semin Hematol. 1998;35
(2)(suppl 2):4-10. 5. Edwards J, Kirby N. Recombinant coagulation factor IX
(BeneFIX®). In: Walsh G, Murphy B, eds. Biopharmaceuticals, an Industrial
Perspective. Dordrecht, The Netherlands: Kluwer Academic Publishers;
1999:73-108. 6. IMS Health National Prescription data, December 2014.

• The most common adverse reactions (>5%) from
clinical trials were nausea, injection site reaction,
injection site pain, headache, dizziness and rash.
You are encouraged to report negative side effects
of prescription drugs to the FDA. Visit www.fda.gov/
medwatch, or call 1-800-FDA-1088.

*BeneFIX was approved February 11, 1997.1
BeneFIX was studied in previously untreated patients, previously treated
patients, and patients with hemophilia B undergoing surgery.2

†

Manufactured by Wyeth Pharmaceuticals Inc.
BUS783101-01
© 2015 Pfizer Inc.

All rights reserved.

Marketed by Pfizer Inc.
October 2015