Bleeding disorders:

Indications for NOVOSEVEN RT:

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.

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.

Boxed Warning:

Thrombosis.

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.

Pharmacologic Class:

Clotting factor.

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.

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).

How Supplied:

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

Pricing for NOVOSEVEN RT

1 vial of 1mg kit (Qty: 1)
Appx. price $2390
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