Sevenfact Generic Name & Formulations
Coagulation Factor VIIa (recombinant)-jncw 1mg, 5mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Single-use vials—1, 5
Treatment and control of bleeding episodes in adults and children with hemophilia A or B with inhibitors.
Limitations of Use
Not indicated for the treatment of congenital Factor VII deficiency.
Sevenfact Dosage and Administration
See full labeling. Give by IV bolus over ≤2mins. Mild/moderate bleeding: 75mcg/kg every 3hrs until hemostasis is achieved; or initially 225mcg/kg, if hemostasis is not achieved within 9hrs, additional 75mcg/kg may be given every 3hrs as needed to achieve hemostasis. Consider alternative treatments if bleeding is not controlled within 24hrs of first administration. Severe bleeding: initially 225mcg/kg, if hemostasis is not achieved after 6hrs, give 75mcg/kg every 2hrs until achieved. Both: cumulative daily doses >900mcg/kg have not been studied.
<12yrs: not established.
Known allergy to rabbits or rabbit proteins.
Sevenfact Boxed Warnings
Increased risk of thromboembolic events esp. in those with history of congenital or acquired hemophilia on concomitant activated or non-activated prothrombin complex or other hemostatic agents, history of atherosclerotic disease, coronary artery disease, cerebrovascular disease, crush injury, septicemia, thromboembolism. Monitor for signs/symptoms of coagulation activation or thrombosis; discontinue or reduce dose if occurs. Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) do not correlate with clinical response to Sevenfact. Elderly. Pregnancy. Advise males of reproductive potential to avoid sexual activity without condoms. Nursing mothers.
Concomitant activated or non-activated prothrombin complex concentrates; may increase risk of serious thrombotic events. Do not mix with other infusion solutions.
Sevenfact Adverse Reactions
Headache, dizziness, infusion-site discomfort/hematoma, infusion-related reaction, fever; hypersensitivity reactions (discontinue and treat if occur), possible neutralizing antibodies formation.
Sevenfact Clinical Trials
Sevenfact Patient Counseling