Kedrion Biopharma announced that the Food and Drug Administration (FDA) has approved the packaging of Koate Double Viral Inactivation (DVI) Antihemophilic Factor VIII (human) with Mix2Vial, a needle-free transfer device.
Koate-DVI is a plasma-derived product indicated for use in the treatment of hemophilia A. The administration of Koate-DVI provides an increase in plasma levels of Factor VIII and can temporarily correct the coagulation defect in these patients.
The new approved packaging allows patients enhanced safety and convenience when reconstituting Koate-DVI, and the needle-free design reduces the risk of accidental needle sticks. The Mix2Vial device is made of plastic with a built-in filter that allows for faster and easier infusions. Moreover, the new device requires fewer steps for product preparation with a fast vial-to-vial transfer.
Prior to the Mix2Vial packaging, Koate-DVI reconstitution required the use of a double-ended transfer needle and three steps to prepare the product prior to administration.
The Mix2Vial vials will launch in the spring as a supplement to the Koate-DVI packaging. Koate-DVI is currently available as 250 IU, 500 IU, and 1000 IU strengths in single-use vials.
For more information visit Koate-DVIusa.com.