Recombinant Human Coagulation Factor VIIa for Injection

Recombinant human coagulation factor VIIa contains activated recombinant coagulation factor VII. The hemostatic mechanism involves the binding of FVIIa to tissue factor. The complex formed activates FIX to FIXa and FX to FXa to trigger the conversion of prothrombin to thrombin, which activates platelets and coagulation factors V and VIII at the site of injury and forms a hemostatic plug by converting fibrinogen to fibrin. Pharmacological doses of this product can activate FX directly on the surface of activated platelets at the site of injury, independent of tissue factor. This allows prothrombin to be converted into large amounts of thrombin without relying on tissue factor. Therefore, the pharmacodynamic effects of coagulation factor VIIa lead to increased local coagulation factor Xa, thrombin, and fibrin production.

Ingredients and composition: Recombinant human coagulation factor VIIa60KIU (1.2 mg)

It is used for the following patient groups to treat bleeding episodes and prevent bleeding during surgical procedures or invasive procedures. 1. Congenital hemophilia patients with inhibitors of coagulation factor VIII or IX > 5BU; 2. Congenital hemophilia patients who are expected to have a high memory response to injection of coagulation factor VIII or coagulation factor IX; 3. Acquired hemophilia patients; 4. Congenital FVII deficiency patients; 5. Thrombasthenia patients with GPⅡb-Ⅲa and/or HLA antibodies and who have been or are currently ineffective or poorly responsive to platelet transfusions.

Hemophilia A or B with inhibitors or acquired hemophilia Dosage This product should be given as soon as possible after the onset of a bleeding episode. The recommended starting dose is 90 mg/kg body weight for intravenous push administration. Another injection may be required after the initial injection of this product. The course of treatment and the interval between injections will vary depending on the severity of the bleeding and the invasive procedures or surgeries performed. The interval between medications is initially 2-3 hours apart to achieve hemostasis. If continued treatment is required, once effective hemostasis is achieved, the dose can be increased to every 4.6, 8 or 12 hours as long as treatment is required. In outpatient treatment of mild to moderate bleeding episodes (including outpatient treatment), the dose for early intervention is set at 90 mg/kg body weight.

This product is contraindicated if you are allergic to the active ingredients, excipients, or mouse, hamster or bovine proteins contained in this product.

The risk of potential interactions between this product and coagulation factor concentrates is unknown. The concomitant use of activated or inactivated prothrombin complex concentrates with this product should be avoided. Antifibrinolytic drugs have been reported to reduce blood loss in surgical procedures in patients with hemophilia, especially in orthopedic surgery and in areas with high fibrinolytic activity, such as the oral cavity. However, there is limited experience with the concomitant use of antifibrinolytic drugs with this product.

This product should be stored at 2℃-8℃ (in a refrigerator);

2mg (100KIU)/vial