It's My Life
It's My Life It's My Life Hemophilia Village
Information for Health Care Professionals
Product Information Indication/Safety Information Tell a Friend Site Map
It's My Life

Home
About Hemophilia
Programs & Services
Treating Hemophilia
About BeneFIX
About ReFacto
Personal Stories
News & Resources
News
News Archive
Events Calendar
Online Resources
Publications
Wyeth & Hemophilia
Wyeth
News Archive

 

Wyeth Pharmaceuticals Introduces the First 2000 IU Vial of ReFacto® for Hemophilia Treatment

Larger Vial Size Provides Greater Convenience

St. Davids, Pa. (October 11, 2002) - Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today the introduction of a 2000 IU vial for ReFacto® Antihemophilic Factor (Recombinant), the company's recombinant factor VIII product for the treatment of hemophilia A.

With the introduction of the 2000 IU (International Units) vial, Wyeth becomes the first manufacturer to introduce product in this vial size. The new vial contains more ReFacto with the same small volume (4 mL) of reconstitution.

"Since the introduction of ReFacto, we've received requests from the community for a larger vial size. The availability of the new vial size should translate to greater dosing convenience for individuals using ReFacto," says Victoria Kusiak, Vice President, Global Medical Affairs and North American Medical Director, Wyeth Pharmaceuticals.

Currently, ReFacto is available in four vial sizes: 250 IU, 500 IU, 1000 IU and now, 2000 IU. Many individuals require infusions of greater than 2000 IU per dose, which necessitates that they use a variety of vials to create their dosage. With the availability of a larger size, these patients will be able to use fewer vials, allowing for easier, faster administration. In addition, the larger vial size is expected to be useful in the surgical setting, which often requires higher doses of antihemophilic factor.

Hemophilia is a rare, inherited blood clotting disorder for which there currently is no cure. People with hemophilia are deficient in the key proteins that are vital in the clotting cascade to prevent bleeding -- factor VIII (hemophilia A) or factor IX (hemophilia B). Both forms of hemophilia are characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. In the United States, nearly 4,000 people have hemophilia B and between 15,000 and 17,000 people have hemophilia A.

ReFacto is a recombinant factor VIII product formulated without the addition of human serum albumin in its final formulation. ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis in hemophilia A patients and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown. As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins.

The Chinese hamster ovary cell line used to produce ReFacto is grown in culture medium that contains human serum albumin; no albumin is added during purification or in final formulation. Following purification, the albumin concentration is below the detection limit of the assay. For more information, call the Hemophilia Hotline at 1-888-999-2349 or visit www.hemophiliavillage.com.

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines.

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

Back to News Archives


   
Privacy Policy | Terms and Conditions
The information on this site is only intended for residents of the United States.
© 2007, Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101
119533-01