Afstyla (antihemophilic factor VIII recomb,single-chn,B-dom truncated)

Antihemophilic factor (recombinant), single chain is a recombinant preparation of blood coagulation factor VIII consisting of a single polypeptide chain with a truncated B-domain with covalent linkage between factor VIII heavy and light chains.

Antihemophilic factor (recombinant), single chain is a recombinant preparation of blood coagulation factor VIII consisting of a single polypeptide chain with a truncated B-domain with covalent linkage between factor VIII heavy and light chains. Covalent linkage between the heavy and light chains maintains a single-chain structure that enhances molecular stability and von Willebrand factor (VWF) affinity. With the exception of a novel N-glycosylation site at the heavy-light chain junction, post-translational modifications are comparable to those of endogenous factor VIII.

Antihemophilic factor (recombinant), single chain is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells and undergoes a series of purification and viral reduction processes. No human- or animal-derived proteins are used in the purification or formulation processes. Compared with plasma-derived antihemophilic factor preparations, recombinant preparations of antihemophilic factor are associated with a substantially reduced risk of transmission of bloodborne human viruses (e.g., human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV)).

Following administration of the first 50-unit/kg dose of antihemophilic factor (recombinant), single chain given as an IV injection in previously treated adults and adolescents, the half-life of the drug was 14.2 hours in adults and 14.3 hours in adolescents (>=12 to <18 years of age). The pharmacokinetic profile obtained 3-6 months after the initial assessment was comparable with the pharmacokinetic profile obtained after the first dose. In previously treated children >=6 to <12 years of age and children 0 to <6 years of age, the half-life of the drug was 10.2 hours, and 10.4 hours, respectively, following administration of a single 50-unit/kg dose of drug.

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 recomb,single-chn,B-dom truncated
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 Afstyla:

• Bleeding Episode In Hemophilia A
• Bleeding Prevention In Hereditary Factor Viii Deficiency
• Hemophilia A

Also known as: Bleeding Prevention In Classic Hemophilia, Bleeding Prevention In Congenital Factor Viii Deficiency, Bleeding Prevention In Hemophilia A, Bleeding Prophylaxis In Hemophilia A, Congenital Factor Viii Deficiency Disease, Hemorrhage Prophylaxis In Hemophilia A, Hemorrhaging In Hemophilia A, Prevention Of Bleeding Episode In Hemophilia A.