Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized.

Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P is a stable, purified, sterile, lyophilized concentrate of Antihemophilic Factor (Human) and von Willebrand Factor (VWF) (Human) to be administered by the intravenous route in the treatment of patients with classical hemophilia (hemophilia A) and von Willebrand disease (VWD) (see CLINICAL PHARMACOLOGY). Humate-P is purified from the cold insoluble fraction of pooled human fresh-frozen plasma and contains highly purified and concentrated Antihemophilic Factor/von Willebrand Factor Complex (Human). Humate-P has a high degree of purity with a low amount of non-factor proteins. Fibrinogen is less than or equal to 0.2 mg/mL. Humate-P has a higher Factor potency than cryoprecipitate preparations. Each vial of Humate-P® contains the labeled amount of Factor VIII activity in international units. Additionally, each vial of Humate-P® also contains the labeled amount of von Willebrand Factor:Ristocetin Cofactor (VWF:RCo) activity expressed in IU (see DOSAGE AND ADMINISTRATION). An international unit (IU) is defined by the current international standard established by the World Health Organization. One IU Factor VIII or 1 IU VWF:RCo is approximately equal to the level of Factor VIII or VWF:RCo found in 1.0 mL of fresh-pooled human plasma. Upon reconstitution with the volume of diluent provided (Sterile Diluent for Humate-P®), each mL of Humate-P contains 40 to 80 IU Factor VIII activity, 72 to 224 IU VWF:RCo activity 1 , 15 to 33 mg of glycine, 3.5 to 9.3 mg of sodium citrate, 2 to 5.3 mg of sodium chloride, 8 to 16 mg of Albumin (Human), 2 to 14 mg of other proteins and 10 to 30 mg of total proteins. This product is prepared from pooled human plasma collected from U.S. licensed facilities in the U.S. All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative). An investigational NAT for HBV was also performed on all Source Plasma used in the manufacture of this product and found to be nonreactive (negative). The aim of the HBV test is to detect low levels of viral material, however, the significance of a nonreactive (negative) result has not been established. Humate-P is heat-treated in aqueous solution at 60°C for 10 hours. This pasteurization protocol has been shown in vitro to inactivate both enveloped (e.g., Human Immunodeficiency Virus [HIV], Herpes Simplex Virus [HSV-1], Bovine Viral Diarrhea Virus [BVDV], and Cytomegalovirus [CMV]) and non-enveloped (e.g., Poliovirus) viruses. However, no procedure has been shown to be totally effective in removing the risk of viral infectivity from coagulant factor concentrates (see CLINICAL PHARMACOLOGY and WARNINGS). Humate-P has been demonstrated in several studies to contain the high molecular weight multimers of VWF. This component is considered to be important for correcting the coagulation defect in patients with VWD (see CLINICAL PHARMACOLOGY). Humate-P contains anti-A and anti-B blood group isoagglutinins (see PRECAUTIONS, Laboratory Tests).