Grifols has announced the availability of a new 2,000 IU/vial assay size for ALPHANATE®, the company’s plasma-derived factor VIII (FVIII)/von Willebrand factor product. The new vial size is available starting October 1, 2014.
ALPHANATE is indicated for the prevention and control of bleeding in patients with hemophilia A. It is also indicated for surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. ALPHANATE is not indicated for patients with severe VWD (Type 3) undergoing major surgery.
According to Grifols, the higher potency allows patients who previously used a 1,500 IU assay to reduce their potential total administration time by 30%. “This higher potency offers a significant advantage to hemophilia A patients that require high dose therapy,” said Joel Abelson, President of North American Commercial Operations. “Since the approval of the 2,000 IU FVIII assay, ALPHANATE has twice the factor and half the volume of any other FVIII/VWF complex product. The larger assay may help patients decrease their overall infusion time and will reduce the total volume needed for a high dose infusion.”
Source: Grifols
