IDELVION Now Approved
Leigh Carpenter, RPh
Director of Pharmacy
CSL Behring announced March 4 that the FDA has approved IDELVION, its long-acting recombinant factor IX product. With IDELVION, the half-life of recombinant factor IX is extended through fusion with recombinant albumin. In clinical trials, the product maintained factor IX activity above 5 percent over 14 days at 75 units/kg dosing. It is indicated in children and adults with hemophilia B for routine prophylaxis, on-demand therapy and perioperative management. If appropriate, some patients can go up to 14 days between infusions.
IDELVION was approved based on results from the PROLONG-9FP clinical trial studies in children and adults (ages one to 61 years) with severe hemophilia B (less than or equal to 2 percent). In patients 12 years of age and older, the recommended starting dose for prophylaxis is 25-40 units/kg infused every seven days. After being well controlled at this dosing interval, some patients may be increased to 50-75 units/kg every 14 days. Children less than 12 years old are recommended to infuse 40-55 units/kg every seven days. It is recommended to adjust the dosing regimen based on individual response.
IDELVION will be supplied in kits of four different assay ranges: 250, 500, 1,000 and 2,000 units. Each size will be reconstituted with 2.5ml sterile water (5ml for the 2,000 unit size). Each kit will contain a Mix2Vial for needleless mixing. IDELVION may be stored in the refrigerator or at room temperature (36-77 degrees Fahrenheit). Once mixed, it must be used within four hours. Do not use IDELVION or the sterile water for injection beyond the expiration date printed on the carton and vial labels. The most common side effect in clinical trials was headache.
If you have questions about IDELVION, please contact your Hemophilia Treatment Center.