Alprolix Now Approved
By Leigh Carpenter, RPh, Director of Pharmacy
Biogen Idec’s newly approved recombinant factor IX with prolonged half-life, Alprolix, has been approved by the FDA and will be commercially available for patients beginning in May. It is indicated in adults and children with hemophilia B 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 IX 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 IX with a longer half-life. Alprolix is not derived from human or animal blood and is manufactured by the HEK (human embryonic kidney) cell line, developed in 1977.
Alprolix was approved after the conclusion of a Phase 3 clinical trial called the B-LONG study in adolescents and adults. These studies showed a prolonged circulation of recombinant factor IX in the body. For routine prophylaxis, it is recommended to infuse 50 units/kg once weekly or 100 units/kg once every 10 days as a starting regimen. Dosing should be adjusted based on individual response. Guidelines are also listed in the package insert for treating minor, moderate, and major bleeding episodes. Alprolix is approved for both adults and children under 12 years of age; however, special dosing regimens may need to be considered for children under 12.
Alprolix will be supplied in kits containing 4 different assay ranges: 500, 1000, 2000, and 3000 units. Each size will be reconstituted with a 5ml sterile diluent syringe included in the kit. After mixing, patients and/or their caregivers must swirl the medication vial from 1 to 4 minutes to go into solution. The kits also contain vial adapters for needle-less mixing. Store Alprolix in the refrigerator (36 to 46 degree 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 temp, do not place the product back into refrigeration. Discard any product not used within 3 hours after reconstitution.
If you are interested in trying Alprolix, please contact your Hemophilia Treatment Center physician since the Hemophilia of Georgia and Beacon pharmacies will need a new prescription. Please contact the pharmacy staff or your outreach nurse if you have further questions.