Article I found today with all the warnings, indication, and safety precautions…….
Innovative BayCuff(TM) Program Empowers Young Members of Hemophilia A Community to Take Control of Their Treatment
WAYNE, N.J., July 9 /PRNewswire/ — Today, Bayer HealthCare Pharmaceuticals launched the BayCuff(TM) self-infusion training program, an educational initiative designed to make infusion of recombinant factor VIII easier for both patients with hemophilia A and for their caregivers. The centerpiece of the program is an adjustable cuff worn on the hand or arm that allows patients to practice the technique of self-injection without actually infusing themselves and helps caregivers learn to administer home infusions for others.
The program was developed to provide members of the hemophilia A community a life-like experience and give them skills, knowledge and confidence as they progress toward self-administration of their therapy. It helps patients rely more on themselves than family members or a nurse to receive their factor therapy, and thus feel more in control of their condition. It is recommended that patients initially use BayCuff with the assistance of a caregiver or healthcare professional.
Hemophilia A is a genetic condition characterized by missing or reduced levels of the blood clotting protein factor VIII leading to prolonged or uncontrolled bleeding episodes. Treatment of this disease may require the infusion of factor VIII therapy sometimes once, twice or three times per week. Until they can learn to infuse themselves, patients receive these infusions either from a parent or nurse. The BayCuff self-infusion training program provides the tools and educational materials needed to teach children how to self-inject in a manner that is both safe and secure. In addition, feedback from the hemophilia community has indicated that BayCuff could be utilized by caregivers who occasionally need to help adult patients infuse themselves.
“The idea for BayCuff was the result of 10 years of working with boys with hemophilia A and their families,” said Tessa Speller RN, formerly of the Henry Ekert Hemophilia Centre, Royal Children’s Hospital, Melbourne, Australia, and inventor of BayCuff(TM). “For both parents and boys themselves, self-treatment brings the ultimate goal – independence. The BayCuff self-infusion training program allows them to address issues such as needle phobias, working with their non-dominant hand and using veins they have not used before. Materials are designed to incorporate basic as well as more advanced information so teaching can be adapted based on the child’s level of understanding. I applaud Bayer for making this innovative program available to the thousands of children who live with hemophilia A.”
The BayCuff training program, being distributed exclusively by Bayer HealthCare to healthcare providers, is available to all patients at no cost. It is important for patients and/or parents to receive proper instruction on its use from their healthcare provider. The program comes in a blue tote with all components, including the adjustable cuff, tubing veins containing non-toxic, washable mock blood, pre-filled syringes and other materials required for infusion plus an instructional video and instructional manual for patients with hemophilia A and caregivers, as well as one for healthcare providers. The BayCuff program is designed to be used by any patient, regardless of their hemophilia A therapy.
“The BayCuff self-infusion training program started with Bayer listening to the needs of the hemophilia A community and then partnering with experts to develop an innovative approach,” said Paul Bedard, Vice President and General Manager, Hematology, Bayer HealthCare Pharmaceuticals. “Along with Kogenate(R) FS, antihemophilic factor (recombinant), Bayer is committed to providing progressive educational support services that empower patients with hemophilia A to better understand and take greater control of their condition and gain independence.”
For additional information on the BayCuff(TM) self-infusion training program or Kogenate(R) FS, please visit www.kogenatefs.com.
INDICATIONS
Kogenate(R) FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.
IMPORTANT SAFETY INFORMATION ABOUT KOGENATE(R) FS
The most serious adverse reactions are systemic hypersensitivity reactions and the development of high titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Kogenate(R) FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full prescribing information for important risk and use information at www.kogenatefs.com.
About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A, the most common type of hemophilia, is caused by deficient or defective blood coagulation proteins, known as factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately one in 5,000 males born in the United States has hemophilia.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare, an affiliate of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
BAYER, the Bayer Cross and Kogenate are registered trademarks of Bayer HealthCare Pharmaceuticals.
SOURCE Bayer HealthCare Pharmaceuticals Inc.
