• Bleeding disorders

Sevenfact Generic Name & Formulations

General Description

Coagulation Factor VIIa (recombinant)-jncw 1mg, 5mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.

Pharmacological Class

Clotting factor.

How Supplied

Single-use vials—1, 5


Generic Availability


Sevenfact Indications


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.

Sevenfact Contraindications


Known allergy to rabbits or rabbit proteins.

Sevenfact Boxed Warnings

Boxed Warning


Sevenfact Warnings/Precautions


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.

Sevenfact Pharmacokinetics

See Literature

Sevenfact Interactions


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

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

See Literature

Sevenfact Note

Not Applicable

Sevenfact Patient Counseling

See Literature