Congenital factor VII deficiency.

NovoSeven® is an effective treatment for patients with congenital factor VII deficiency.1

Congenital factor VII deficiency.

NovoSeven® is an effective treatment for patients with congenital factor VII deficiency.1

Tab Efficacy

Offering the proven efficacy they expect.

NovoSeven® RT was 93% effective at stopping nonsurgical and surgical bleeds in people with congenital factor VII deficiency.1,2,a  

aData from the published literature and internal sources for patients with FVII deficiency (N=75) treated with NovoSeven® for 124 bleeding episodes, surgeries, or prophylaxis regimens. Dosing ranged from 6 mcg/kg administered every 2 to 12 hours (except for prophylaxis [doses administered from 2 times per day up to 2 times per week]). Patients were treated with an average of 1 to 10 doses. Treatment was effective if bleeding stopped or the physician rated the treatment as effective.1,2  
 

Tab Tailored Dosing

Adjustable dosing.

Based on the severity of bleeding, adjust dose and frequency of injections to each individual patient.

bThe minimum effective dose has not been determined.

Dosing recommendation for congenital factor VII deficiency.1,b

CONGENITAL FACTOR VII DEFICIENCY

15-30 mcg/kg

every 4-6 hours

until hemostasis is achieved


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


b
The minimum effective dose has not been determined.
 

Tab Safety Profile

The safety they deserve.

NovoSeven® RT is the only recombinant bypassing agent not made from human serum or proteins. Recombinant manufacturing minimizes the possibility of viral contamination.1,3

Tab 3-step reconstitution

The rapid access to treatment that keeps them on the go.

NovoSeven® RT is room temperature stable up to 77°F.1,c

cPrior to reconstitution, store NovoSeven® RT powder and histidine diluent between 36–77°F. After reconstitution, store NovoSeven® RT either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven® RT or store in syringes.

Thermometer displaying 77˚F

Quick reconstitution can save them time.

Every vial comes with a prefilled syringe, meaning no extra steps to fill a syringe with diluent.1,d  


dCompared with reconstitution using histidine vials.

Doctor attending to girl in hospital bed

Approved for surgical use and

procedures in patients with

congenital hemophilia FVII deficiency.


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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.  

 

References:

  1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.
  2. Mariani G, Napolitano M, Dolce A, et al. Replacement therapy for bleeding episodes in factor VII deficiency. A prospective evaluation. Thromb Haemost 2013; 109: 238–247.

  3. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #250. New York, NY: National Hemophilia Foundation; 2017.