- Xyntha® Solofuse® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Prescribing Information, Wyeth Pharmaceuticals Inc.
- 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/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 5, 2012.
- BeneFix® Coagulation Factor IX (Recombinant) Prescribing Information, Wyeth Pharmaceuticals Inc. 11.2011.
Scroll for Important Safety Information and Indications
Important Safety Information for XYNTHA
- Do not use in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins.
- Allergic-type hypersensitivity reactions are possible. Inform patients of the early signs or symptoms (including hives, generalized urticaria, chest tightness, wheezing, and hypotension) and anaphylaxis. If these symptoms occur, advise patients to discontinue use of the product and contact their physician. XYNTHA contains trace amounts of hamster proteins. Patients may develop hypersensitivity to these proteins.
- Patients using coagulation factor VIII products should be monitored for inhibitors, which have been reported in patients receiving XYNTHA.
- Clinical response to XYNTHA may vary. If bleeding is not controlled with the recommended dose of factor, determine the plasma level and administer a dose of XYNTHA sufficient to achieve clinical response. If the factor level does not increase or there is no response, suspect an inhibitor and perform appropriate testing.
- The most common adverse reaction in the safety and efficacy study is headache (24% of subjects) and in the surgery study is fever (43% of subjects). Overall, the most common adverse reactions (≥5% of subjects) in clinical studies were headache, fever, nausea, vomiting, diarrhea, and weakness.
- 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®.
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.
Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.
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.
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.
Please see full Prescribing Information for BeneFix.