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Recommended dosing for treatment of bleeding episodes and surgery.1

NovoSeven® RT should be given as soon as possible after a bleeding episode starts.

For detailed dosing information, please see the Prescribing Information.

CONGENITAL HEMOPHILIA A OR B WITH INHIBITORS

(for perioperative management)

MINOR:

Initial:

90 mcg/kg immediately before surgery

repeat every 2 hours during surgery

Post surgical:

90 mcg/kg every 2 hours after surgery for 48 hours

then every 2-6 hours until healing occurs

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MAJOR:

Initial:

90 mcg/kg immediately before surgery

repeat every 2 hours during surgery

Post surgical:

90 mcg/kg every 2 hours after surgery for 5 days

then every 4 hours until healing occurs

ACQUIRED HEMOPHILIA

(for perioperative management)

MINOR OR MAJOR:

70-90 mcg/kg immediately before surgery and every 2-3 hours

for the duration of surgery and until hemostasis is achieveda

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CONGENITAL FACTOR VII

(for perioperative management)

MINOR OR MAJOR:

15-30 mcg/kg immediately before surgery and every 4-6 hours

for the duration of surgery and until hemostasis is achieveda

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GLANZMANN’S THROMBASTHENIA

WITH REFRACTORINESS TO PLATELET TRANSFUSIONS, WITH OR WITHOUT ANTIBODIES TO PLATELETS
(for perioperative management)

MINOR OR MAJOR:

Initial:

90 mcg/kg immediately before surgery and every 2 hours

for the duration of the procedurea

Post surgical:

90 mcg/kg every 2 hours to prevent post-operative bleedinga

Higher average infused doses (median dose was 100 micrograms per kg (IQR 90-140)) were noted for surgical patients who had clinical refractoriness with or without platelet-specific antibodies compared to those with neither

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aThe minimum effective dose has not been determined.

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Selected Important Safety Information

WARNING: THROMBOSIS

  • Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported.
  • Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT.
  • Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for:

  • Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets
  • Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia

 

Important Safety Information

WARNING: THROMBOSIS

  • Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported.
  • Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT.
  • Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

Warnings and Precautions

  • Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance.
  • Exercise caution when administering NovoSeven® RT to patients with an increased risk of thromboembolic complications, such as those with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, uncontrolled post-partum hemorrhage, history of coronary heart disease, liver disease, post-operative immobilization, in elderly patients, in neonates, or in patients receiving concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates).
  • Hypersensitivity reactions, including anaphylaxis, have been reported with NovoSeven® RT. Administer only if clearly needed in patients with known hypersensitivity to NovoSeven® RT, any of its components, or mouse, hamster, or bovine proteins. Should symptoms occur, discontinue NovoSeven® RT and administer appropriate treatment.
  • Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity (FVII:C). If FVII:C fails to reach the expected level, or PT is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed.
  • Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis.

Adverse Reactions

  • The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven® RT in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia.

Drug Interactions

  • Thrombosis may occur if NovoSeven® RT is administered concomitantly with Coagulation Factor XIII.

Please click here for Prescribing Information.  

 

Reference:

  1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.