Obizur (antihemophilic factor VIII, recombinant porcine sequence)

Antihemophilic factor (recombinant), porcine sequence is a biosynthetic (recombinant DNA origin) preparation of porcine coagulation factor VIII.

Antihemophilic factor (recombinant), porcine sequence is a biosynthetic (recombinant DNA origin) preparation of porcine coagulation factor VIII. The recombinant product differs from naturally occurring porcine factor VIII by the absence of the B domain, which has been replaced with a 24-amino acid linker. Antihemophilic factor (recombinant), porcine sequence is structurally and functionally similar to endogenous human factor VIII.

Coagulation factor VIII is essential for blood clotting and maintenance of effective hemostasis. Patients with acquired hemophilia A have a functional deficiency of factor VIII due to the development of autoantibodies against the coagulation factor. Patients with acquired hemophilia A typically exhibit bleeding into the skin, muscles, soft tissues, and/or mucous membranes; hemarthrosis occurs less frequently, unlike in patients with congenital hemophilia A.

Administration of antihemophilic factor (recombinant), porcine sequence in patients with acquired hemophilia A temporarily replaces the inhibited factor VIII required for effective hemostasis. Due to reduced cross-reactivity (about 5-10%) with human factor VIII inhibitors, antihemophilic factor (recombinant), porcine sequence can function effectively in the presence of autoantibodies to factor VIII. Once activated in the coagulation cascade, the hemostatic effects of antihemophilic factor (recombinant), porcine sequence are comparable to that of endogenous human factor VIII.

Antihemophilic factor (recombinant), porcine sequence is produced by recombinant DNA technology in a baby hamster kidney (BHK) cell line and undergoes a series of purification processes, including two dedicated viral inactivation/removal steps (solvent/detergent treatment, nanofiltration), to further reduce the potential for viral transmission. The final product is free of any additives of human or animal origin. Potency of antihemophilic factor (recombinant), porcine sequence is expressed in terms of units of antihemophilic factor activity as determined by the one-stage clotting assay.

Potency values determined by the chromogenic assay may be 20-50% lower than those measured by the one-stage clotting assay.

USES: This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles).

This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease.

Generic name: antihemophilic factor VIII, recombinant porcine sequence
Pronunciation: (AN-tye-HEE-moe-FIL-ik FAK-tor, ree-KOM-bi-nant)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents

The following indications are listed for Obizur:

• Bleeding Episode In Acquired Factor Viii Deficiency Disease