Recommended dosing for treatment of bleeding episodes.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 bleeding episodes)


BEFORE HEMOSTASIS IS ACHIEVED

90 mcg/kg

every 2 hours

adjustable based on severity of bleeding, until hemostasis is achieved, or until the treatment has been judged to be inadequate

AFTER HEMOSTASIS IS ACHIEVED

90 mcg/kg

every 3-6 hoursa

after hemostasis is achieved to maintain the hemostatic plug

ACQUIRED HEMOPHILIA

(for bleeding episodes)


70-90 mcg/kg every 2-3 hours

until hemostasis is achieved

CONGENITAL FACTOR VII

(for bleeding episodes)


15-30 mcg/kg every 4-6 hours

until hemostasis is achieved

Effective treatment has been achieved with doses as low as 10 micrograms per kg body weight

Adjust dose and frequency of injections to each individual patient

GLANZMANN'S THROMBASTHENIA

WITH REFRACTORINESS TO PLATELET TRANSFUSIONS, WITH OR WITHOUT ANTIBODIES TO PLATELETS
(for bleeding episodes)


90 mcg/kg every 2-6 hours

in severe bleeding episodes requiring systemic hemostatic therapy until hemostasis is achieved

Platelet transfusions are the primary treatment in patients with Glanzmann’s thrombasthenia without refractoriness to platelets or in patients without platelet-specific antibodies

aThe appropriate duration of post-hemostatic dosing has not been studied.

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.