Page 57 - InsideOut Magazine

Your EXPErIENCE. A dECIdINg fACtor.
• Demonstrated bleed control across a wide range of patient types2† • An established safety profifile in previously untreated and
• An all-inclusive Rapid Reconstitution (R2) Kit provides convenience for your patients’ busy lives
Stick with the most prescribed recombinant factor IX for hemophilia B6
• Development of activity-neutralizing antibodies
has been detected in patients receiving factor IX products. If expected plasma factor IX activity levels are not attained, or if patient presents with allergic reaction, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed.
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; November 2011. 3. Adamson S, Charlebois T, O’Connell B, Foster W. Viral safety of recombinant factor IX. Semin Hematol. 1998;35(2, suppl 2):22-27. 4. Harrison S, Adamson S, Bonam D, et al. The manufacturing process for recombinant factor IX. Semin Hematol. 1998;35
1
(2, suppl 2):4-10. 5. Edwards J, Kirby N. Recombinant coagulation factor IX ®
(BeneFix ).In:WalshG,MurphyB,eds.Biopharmaceuticals,anIndustrial Perspective. Dordrecht, The Netherlands: Kluwer Academic Publishers; 1999:73-108. 6. IMS Health National Prescription data, September 2013.
• The most common adverse reactions (>5%) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash.
BeneFix was studied in previously untreated patients, previously treated 2
• Patients may develop hypersensitivity to hamster (CHO) protein as BeneFix contains trace amounts.
*BeneFix was approved February 11, 1997. †
Please see brief summary of full Prescribing Information on next page.
patients, and patients with hemophilia B undergoing surgery.
BeneFix®—the factor IX you’ve turned to for more than 17 years*
previously treated patients2
• Expertise in third-generation recombinant technology with sustained supply from Pfifizer3-5
Manufactured by Wyeth Pharmaceuticals Inc. BUS634412-01 © 2014 Pfifizer Inc.
Marketed by Pfifizer Inc.
All rights reserved.
ASD Healthcare | 55 Printed in USA/February 2014