One of the most important products of AryoGen Pharmed is Recombinant Activated Human Blood Coagulation Factor VIIa, with the trade name of AryoSeven™. AryoSeven™, (rFVIIa), is a glycoprotein produced in Baby Hamster Kidney cell line (BHK) via recombinant technology and is highly purified to be acceptable as an injectable human medicine. AryoSeven™ is indicated for control, treatment and prevention of bleeding episodes in patients with:
•Congenital hemophilia A or B with inhibitors
• Acquired hemophilia
• Congenital factor VII deficiency
• Glanzmann’s thrombasthenia
AryoSeven™ is marketed in 3 different doses of 1.2 mg (60 KIU), 2.4 mg (120 KIU) and 4.8 mg (240 KIU) as white lyophilised powder for solution for injection which is supplied in a glass vial with a rubber stopper. The solvent vial contains a clear and colorless solution. The reconstituted solution is a colorless solution. After reconstitution with sWFI the final solution contains approximately 0.6 mg/ml of rFVIIa.
The AryoSeven™ package contains:
• One labeled vial with white powder (AryoSeven™) for solution for injection,
• One labeled vial with solvent (sterile Water for Injections) for reconstitution,
• One alcohol swab,
• One syringe.
AryoSeven™ has proven to be as safe and effective as the reference medicinal product. It is to be injected intravenously immediately after the start of a bleeding episode. The recommended doses are:
• In bleeding episodes in patient with congenital hemophilia A and B with inhibitors- 90 μg/kg intravenous bolus injection (over 2-5 minutes) every 2 – 3 hours until hemostasis is achieved.
• In bleeding episodes in patient with acquired hemophilia- 90 μg/kg every 2 to 3 hours until hemostasis is achieved.
• In bleeding episodes and surgical interventions in patient with congenital factor VII deficiency- 15-30 μg/kg every 4-6 hours until hemostasis is achieved. Dose and frequency of injections should be adapted to each individual.
• In bleeding episodes in patients with Glanzmann’s thromboasthenia- 90 μg/kg (range 80-120 μg /kg) every 2 hours. At least three doses should be administered to secure achievement of effective haemostasis.