Photo courtesy of Baxalta
The US Food and Drug Administration (FDA) has approved the Baxject III reconstitution system for Adynovate, a pegylated recombinant factor VIII (FVIII) product.
The system is designed to mix a FVIII product with a diluent prior to infusion.
The Baxject III reconstitution system was previously FDA-approved for use with Advate, a recombinant FVIII product.
The latest FDA approval means the system will be available with Adynovate as well.
Adynovate and the diluent will come pre-packaged in the reconstitution system.
The Baxject III reconstitution system with Adynovate will be available to most customers in the fourth quarter of 2016, with a 2 mL diluent for the 250, 500, and 1000 IU potencies; and a 5 mL diluent for the 2000 IU potency.
Adynovate was approved by the FDA in 2015 for use in hemophilia A patients age 12 and older for on-demand treatment and control of bleeding and for prophylaxis to reduce the frequency of bleeding episodes. Full prescribing information is available here.
Advate was first approved by the FDA in 2003. The product is indicated for use in children and adults with hemophilia A for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Full prescribing information is available here.
The Baxject III reconstitution system, Adynovate, and Advate are all products of Baxalta, which is now a part of Shire.
