- Xyntha® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is completely albumin-free, plus has replaced a monoclonal antibody with a synthetic ligand and uses a nanofiltration step1,2*
- XYNTHA has been studied, tested, and demonstrated to work in clinical trials1
These innovations in the manufacturing and purification processes were designed with viral safety in mind.
Reconstitution convenience for your patients
- Next-generation purification meets the next step in all-in-one reconstitution convenience with XYNTHA® Solofuse™3
- XYNTHA employs the convenient Rapid Reconstitution (R2) Kit for fast and easy reconstitution in an all-inclusive travel-ready pack1
- XYNTHA R2 Kit uses a distinct, clear vial adapter, needleless transfer system, and low diluent volume1
Clinical Monitoring
- XYNTHA should be clinically monitored using the one-stage clotting assay1
Availability in the United States
- XYNTHA is available in many hospitals across the country.
- XYNTHA is available to patients whether they obtain their factor VIII from a hemophilia treatment center, a specialty pharmacy, or a home health care agency
- Patients should be advised to bring an adequate supply of XYNTHA when traveling, especially when traveling outside the United States2
- Patients will need to obtain a prescription specifically for XYNTHA
- Patients/caregivers should contact their insurance carriers for information on their insurance coverage or call Pfizer's toll-free Hemophilia Hotline at 1.888.999.2349
- If your patients do not have prescription drug insurance and needs help paying for XYNTHA, Pfizer may be able to help. RSVP is a part of the Pfizer Helpful Answers® family of patient assistance programs joint program of Pfizer Inc and the Pfizer Patient Assistance Foundation™ .To find out more click here or call us at 1.888.327.7787 for more information.
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*The chemically defined cell culture medium in which the Chinese hamster ovary (CHO) cells are grown contains recombinant insulin but does not contain any materials derived from added human or animal sources.1
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™.
References:
1. Xyntha® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Prescribing Information, Wyeth Pharmaceuticals Inc.
2. Kelley B, Jankowski M, Booth J. An improved manufacturing process for Xyntha/ReFacto AF. Haemophilia. 2009;1-9. doi:10.1111/j.1365-2516.2009.02160.x.
3. Xyntha® Solofuse™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Prescribing Information, Wyeth Pharmaceuticals Inc.
