First Training Kit To Help People With Hemophilia Learn Self-Infusion Techniques

Self-Infusion Techniques

Wyeth Pharmaceuticals announced the introduction of the Self-Infusion Training Kit, a unique training tool with life-like hand and elbow models that allows individuals to practice techniques for administering hemophilia treatment.

The Self-Infusion Training Kit will be available at no cost to U.S. hemophilia treatment centers for health care professionals to use to educate young people with hemophilia and their families.

"Learning the technical skills needed for self-infusion is a considerable challenge for many young people and their families. Using the life-like models, individuals can feel for a vein, insert a butterfly needle and infuse liquid (mock product) into the model veins. This practice tool will allow young people and their families to gain confidence and experience with the infusion treatment process," says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals.

The comprehensive kit contains synthetic hand and elbow models, which were modeled upon the dimensions of a representative 10-year-old boy. The hand and elbow models feature replaceable artificial skin and veins that allow for repeated practice. The veins inside the model are injection-molded plastic and are designed for five practice infusions before disposal. The replaceable skin is designed for 10 practice infusions. Replacement skin and veins will be available from local Wyeth representatives.

"Self-infusion is an important skill for people with hemophilia. We are very pleased to provide this teaching tool for hemophilia treatment center staff and address an unmet need in hemophilia education and treatment," adds Dr. Stiles.

The kit also includes an infusion mat, tourniquet, butterfly needles, a biohazard disposal container, flush syringe and ReFacto(R) Antihemophilic Factor (Recombinant) R2 Kits for demonstration purposes only. The ReFacto R2 Kit allows patients to practice clotting factor preparation, in addition to infusion. The R2 kits include a prefilled diluent syringe, a vial adaptor and an infusion set. The Self-Infusion Training Kit also contains a CD-ROM for patients and their family members that explains the preparation process.

Hemophilia is a rare, inherited blood clotting disorder for which there currently is no cure. People with hemophilia are deficient in one of the key proteins -- either factor VIII (hemophilia A) or factor IX (hemophilia B) -- that are vital in the clotting cascade to prevent bleeding. Both forms of hemophilia are characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Patients with hemophilia A or hemophilia B are dependent on protein replacement therapy with factor VIII or factor IX, respectively, for life.

ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.

Important Safety Information

* As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions.

* The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto.

* Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur.