Novoseven Rt

  • Bleeding disorders

Novoseven Rt Generic Name & Formulations

General Description

Recombinant Coagulation Factor VIIa (rFVIIa) Room Temperature Stable 1mg, 2mg, 5mg, 8mg; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

Pharmacological Class

Clotting factor.

How Supplied

Single-use vial—1 (w. diluent); MixPro—1 (single-use vial + pre-filled diluent syringe + vial adapter)


Novoseven Rt Indications


Treatment of bleeding and peri-operative management in adults and children with Hemophilia A and B with inhibitors, congenital Factor VII deficiency, and Glanzmann’s thrombasthenia refractory to platelet transfusions, with or without antibodies to platelets. Treatment of bleeding and peri-operative management in adults with acquired hemophilia.

Novoseven Rt Dosage and Administration

Adults and Children

See full labeling. Give by IV bolus inj over 2–5mins. Individualize; base treatment schedule modification on hemostasis evaluation. Hemophilia A or B with inhibitors: Bleeding: 90mcg/kg every 2hrs, adjust until hemostasis is achieved; post-hemostatic dosing: continue at 3–6hrs intervals for severe bleeds. Peri-operative: initially 90mcg/kg prior to surgery, repeat at 2hr intervals during surgery; minor (post-surgical dosing): every 2hrs for 48hrs, then every 2–6hrs until healed; major (post-surgical dosing): every 2hrs for 5 days, then every 4hrs or by continuous infusion at 50mcg/kg/hr, until healed; additional doses can be given. Congenital Factor VII deficiency: Bleeding: 15–30mcg/kg every 4–6hrs until hemostasis is achieved; Peri-operative: 15–30mcg/kg (10mcg/kg can be effective) prior to surgery, repeat every 4–6hrs during surgery and until hemostasis is achieved. Glanzmann’s thrombasthenia: Bleeding: 90mcg/kg every 2–6hrs until hemostasis is achieved; Peri-operative: initially 90mcg/kg prior to surgery, repeat every 2hrs during surgery, then every 2–6hrs post-surgical (100–140mcg/kg can be used for refractory patients with or without platelet-specific antibodies). Acquired hemophilia: Bleeding: 70–90mcg/kg every 2–3hrs until hemostasis is achieved; Peri-operative: 70–90mcg/kg prior to surgery, repeat every 2–3hrs during surgery and until hemostasis is achieved.

Novoseven Rt Contraindications

Not Applicable

Novoseven Rt Boxed Warnings

Boxed Warning


Novoseven Rt Warnings/Precautions


Increased risk of serious thrombotic events esp. in patients with congenital hemophilia on concomitant activated prothrombin complex, history of cardiac or vascular disease, predisposition to thrombotic events, elderly (on other hemostatic agents). Monitor for signs/symptoms of coagulation activation or thrombosis; discontinue or reduce dose if occur. Monitor prothrombin time and FVII coagulant activity before and after dosing in FVII deficiency. Perform analysis for antibodies if factor VIIa activity fails to reach expected level. Mouse, hamster, or bovine protein hypersensitivity. Pregnancy. Nursing mothers.

Novoseven Rt Pharmacokinetics

See Literature

Novoseven Rt Interactions


Avoid concomitant activated or non-activated prothrombin complex concentrates; may increase risk of thrombotic events. Do not mix with infusion solutions. Concomitant Coagulation Factor XIII may cause thrombosis.

Novoseven Rt Adverse Reactions

Adverse Reactions

Thrombotic events, fever, fibrinogen plasma decreased, hypertension, headache, nausea, dyspnea; pain, thrombophlebitis, pulmonary embolism, decreased therapeutic response, cerebrovascular disorder, angina pectoris, abnormal hepatic function, DIC, hypersensitivity reactions (discontinue and treat if occur).

Novoseven Rt Clinical Trials

See Literature

Novoseven Rt Note

Not Applicable

Novoseven Rt Patient Counseling

See Literature