CSL Behring announced that Idelvion (coagulation factor IX [recombinant], albumin fusion protein [rFIX-FP]) has been approved in a new 3500 IU vial size by the Food and Drug Administration (FDA).

Idelvion, a recombinant DNA-derived coagulation Factor IX concentrate, is indicated for patients with hemophilia B: to control and prevent bleeding episodes, for perioperative management of bleeding, and for routine prophylaxis to reduce the frequency of bleeding episodes. The new 3500 IU vial size will help shorten the reconstitution time needed to prepare multiple vials for a similar dose. 

“The 3500 IU vial can be helpful for patients currently on Idelvion or those who might have been waiting until more convenient vial sizes were available in order to begin treatment with Idelvion,” stated Craig Kessler, MD, Director, Division of Coagulation and Director of the Hemophilia and Thrombosis Comprehensive Care Center, Georgetown University Medical Center. 

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Idelvion is currently available in 250 IU, 500 IU, 1000 IU, and 2000 IU vials. The new 3500 IU vial size will be available in the coming weeks. Each kit contains a single-use vial with diluent and supplies.

For more information call (800) 504-5434 or visit Idelvion.com.