Shire announced that the Food and Drug Administration (FDA) has approved the Baxject III reconstitution system for Adynovate (antihemophilic factor [recombinant], PEGylated; Baxalta). 

The Baxject III system decreases the amount of steps for reconstitution for caregivers and patients with hemophilia A. Compared to the previous Baxject II Hi Flow Needleless transfer device, the Baxject III system cuts the number of steps by two. 

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Adynovate, approved in November 2015, is a clotting factor indicated in patients with hemophilia A for on-demand treatment and control of bleeding episodes and routine prophylaxis to reduce the frequency of bleeding episodes in patients aged ≥12 years.

Adynovate and the diluent (2mL or 5mL) will be pre-packaged in the Baxject III reconstitution system in the 4th quarter of 2016. It is available as 250 IU, 500 IU, 1000 IU, and 2000 IU strengths in single-use vials. 

For more information call (800) 999-1785 or visit