Eloctate Now Approved
By Leigh Carpenter, RPh, Director of Pharmacy
Biogen Idec announced on June 6 that the FDA approved Eloctate, their recombinant factor VIII product with a prolonged half-life. It will be commercially available for patients in mid-July. Eloctate is indicated in adults and children with hemophilia A for control and prevention of bleeding episodes, perioperative (surgical) management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. The prolonged half-life is due to a recombinant factor VIII protein that is joined or “fused” to Fc. Fc is normally found as part of a common protein in the body. This “fusion” technology results in factor VIII with a longer half-life. The manufacturing process begins with the production of clotting factor VIII using recombinant DNA technology in the HEK (Human Embryonic Kidney) cell line, developed in 1977. This cell line does not contain any proteins derived from human or animal bleed sources.
Eloctate was approved after the conclusion of a Phase 3 clinical trial called the A-LONG clinical study for adults and adolescents with severe hemophilia A and the Phase 3 Kids A-LONG study. These studies showed a prolonged circulation of recombinant factor VIII in the body. For prophylaxis, the recommended starting regimen is 50 units/kg every 4 days. Based on individual response, the regimen may be adjusted in the range of 25-65 units/kg and every 3-5 days. Studies showed children 2-5 years old have a shorter half-life and higher clearance of hemophilic factors; therefore, a higher dose (up to 80 units/kg) or more frequent dosing may be needed in children less than 6 years of age. No participants in the A-LONG or Kids A-LONG study developed inhibitors to Eloctate.
Eloctate will be supplied in kits containing 7 different assay ranges: 250, 500, 750, 1000, 1500, 2000, and 3000 units. Each size will be reconstituted with a 3ml sterile diluent syringe included in the kit. The kits also contain vial adapters for needleless mixing. Store Eloctate in the refrigerator (36 to 46 degrees Fahrenheit) up until the expiration date printed on the carton, vial or syringe. It may also be stored at room temperature, not to exceed 86 degrees Fahrenheit for a 6 month period. If choosing to store at room temperature, do not place the product back into refrigeration. Do not freeze to avoid damage to the pre-filled diluent syringe. Discard any product not used within 3 hours after reconstitution.
If you are interested in trying Eloctate, please contact your Hemophilia Treatment Center physician since the Hemophilia of Georgia and Beacon pharmacies must have a new prescription. Please contact the pharmacist or your Outreach Nurse if you have additional questions.