What’s New For People Living with Hemophilia?
At Bayer HealthCare Pharmaceuticals Inc., we are constantly innovating to provide you with treatment options. Stay Informed on the latest treatment news by email, or read the most recent news releases from Bayer HealthCare Pharmaceuticals.
FDA Approves New 3000 IU Vial Size for Kogenate® FS, antihemophilic factor (recombinant)
See the full news release here.
Larger Vial Provides Greater Convenience for Patients Requiring Higher Dose
Bayer HealthCare Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a 3000 IU (international unit) vial size of Kogenate® FS, antihemophilic factor (recombinant). The new vial size offers greater convenience for patients with hemophilia A who require a higher dose.
The 3000 IU vial may eliminate the need for combining smaller vials and may allow some patients to achieve more precise dosing. It is available in a conventional vial-to-vial reconstitution system and in Kogenate FS Grab & Go packaging with BIO-SET®, a compact and complete reconstitution system. Grab & Go includes the Terumo® SURFLO® Infusion Set with filter and other materials necessary for safe reconstitution and fast recombinant Factor VIII treatment in a small, tamper-evident box with anticounterfeiting features.
The Kogenate FS line of products now includes the following vial sizes: 250, 500, 1000, 2000 and 3000 IU. Kogenate FS has one of the smallest diluent volumes available. The 250, 500 and 1000 IU vial sizes are provided with 2.5 mL of diluent; the 2000 and 3000 IU vial sizes are reconstituted with 5 mL of diluent. The 3000 IU vial size is now part of the Kogenate FS Free Trial Program, which is open to people with hemophilia A who meet program eligibility criteria.
Bayer HealthCare Launches Hemophilia Self-Infusion Training Program
Innovative BayCuff™ Program Empowers Young Members of Hemophilia A Community to Take Control of Their Treatment
Bayer HealthCare Pharmaceuticals launched the BayCuff™ 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.
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.
