This is your one-stop source for information and educational resources regarding Xyntha^® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, BeneFix^® Coagulation Factor IX (Recombinant), and hemophilia.

Indication for XYNTHA

Xyntha^® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand’s disease.

Important Safety Information for XYNTHA

• Anaphylaxis and severe hypersensitivity reactions are possible. Should such reactions occur, treatment with the product should be discontinued, and appropriate treatment should be administered.
• Patients using coagulation factor VIII products should be monitored for inhibitors, which have been detected in patients receiving factor VIII-containing products, including XYNTHA.
• The most common adverse reaction in study 1 (safety and efficacy study) is headache (24% of subjects) and in study 2 (surgery study) is fever (41% of subjects). The most common adverse reactions (≥5% of subjects) in clinical studies were headache, fever, nausea, diarrhea, vomiting, and weakness.
• Patients may develop hypersensitivity to hamster protein, which is present in trace amounts in XYNTHA.
• XYNTHA is an injectable medicine administered by intravenous (IV) infusion. Patients should be advised that local irritation may occur when infusing XYNTHA after reconstitution in Xyntha^® Solofuse™.

Please see full Prescribing Information for XYNTHA.

Indication for BeneFix

BeneFix^® Coagulation Factor IX (Recombinant) is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including peri-operative management.

BeneFix is NOT indicated for the treatment of other factor deficiencies (eg, factors II, VII, VIII and X), hemophilia A patients with inhibitors to factor VIII, reversal of coumarin-induced anticoagulation, or bleeding due to low levels of liver-dependent coagulation factors.

Important Safety Information for BeneFix

• BeneFix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
• Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with the product should be discontinued, and emergency treatment should be sought.
• BeneFix has been associated with the development of thromboembolic complications, including patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFix administration by continuous infusion have not been established.
• 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.
• Patients may develop hypersensitivity to hamster (CHO) protein as BeneFix contains trace amounts.
• The most common adverse reactions (>5%) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash.

Please see full Prescribing Information for BeneFix.

References:

1. Xyntha^® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Prescribing Information, Wyeth Pharmaceuticals Inc.
2. Kelly B, Jankowski M, Booth J. An improved manufacturing process for Xyntha/ReFacto AF. Haemophilia. 2009;1-9.doi:10.111/j.1365-2516.2009.02160.x.
3. Xyntha^® Solofuse^™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Prescribing Information, Wyeth Pharmaceuticals Inc.
4. Center for Biologics Evaluation and Research, US Food and Drug Administration. Department of Health and Human Services. CBER Approval letter, Coagulation Factor IX (Recombinant), Genetics. http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed November 15, 2011.
5. BeneFix^® Coagulation Factor IX (Recombinant) Prescribing Information, Wyeth Pharmaceuticals Inc. 11.2011.
6. Lambert T, Recht M, Valentino LA, et al. Reformulated Beneix^®: efficacy and safety in previously treated patients with moderately severe to severe haemophilia B. Haemophilia. 2007;13:233-243.