Bleeding disorders:

Indications for SEVENFACT:

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.

Adult Dosage:

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.

Children Dosage:

<12yrs: not established.

SEVENFACT Contraindications:

Known allergy to rabbits or rabbit proteins.

Boxed Warning:

Thrombosis.

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 Classification:

Clotting factor.

SEVENFACT Interactions:

Concomitant activated or non-activated prothrombin complex concentrates; may increase risk of serious thrombotic events. Do not mix with other infusion solutions.

Adverse Reactions:

Headache, dizziness, infusion-site discomfort/hematoma, infusion-related reaction, fever; hypersensitivity reactions (discontinue and treat if occur), possible neutralizing antibodies formation.

Generic Drug Availability:

NO

How Supplied:

Single-use vials—1, 5