Monograph Details

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Hematology > Bleeding disorders

NOVOSEVEN

Manufacturer

Novo Nordisk

Legal Classification

Pharmacological Class

Clotting factors.

Generic Name

Recombinant Human Coagulation Factor VIIa (rFVIIa) 1200mcg, 2400mcg, 4800mcg; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

Indications

Treatment of bleeding and for surgical prophylaxis in Hemophilia A and B with inhibitors to Factors VIII and IX, in acquired hemophilia, and in congenital FVII deficiency.

Adults and Children

Give by IV bolus. Individualize; base treatment schedule on hemostasis. Hemophilia A and B with inhibitors: Bleeding: 90micrograms/kg every 2hrs; post-hemostatic dosing: continue at 3–6hrs intervals for severe bleeds. Surgery: initially 90micrograms/kg prior to surgery, repeat at 2hr intervals during surgery; minor (post-surgical dosing): every 2hrs for 1^st 48hrs, then every 2–6hrs until healed; major (post-surgical dosing): every 2hrs for 5 days, then every 4hrs until healed. Congenital Factor VII deficiency: 15–30micrograms/kg every 4–6hrs until hemostasis acheived. Acquired hemophilia: 70–90micrograms/kg every 2–3hrs until hemostasis acheived.

Contraindications

Mouse, hamster, or bovine protein hypersensitivity.

Precautions

Disseminated intravascular coagulation, advanced atherosclerotic disease, crush injury, septicemia, elderly; increased risk of thrombotic events. Monitor prothrombin time and FVII coagulant activity before and after dosing in FVII deficiency. Monitor for antibody formation. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions

Avoid concomitant activated or non-activated prothrombin complex concentrates; may increase risk of thrombotic events.

Adverse Reactions

Pyrexia, hemorrhage, inj site reactions, arthralgia, headache, hypertension, hypotension, GI upset, pain, edema, rash; thrombosis.

How Supplied

Single-dose vials—1

Additional Resources

• Related Prescribing Note