Glanzmann’s thrombasthenia.

NovoSeven® RT is the only recombinant therapy for patients with Glanzmann's thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets.1

Glanzmann’s thrombasthenia.

NovoSeven® RT is the only recombinant therapy for patients with Glanzmann's thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets.1

Tab Efficacy

Proven effective in a majority of GT-related bleeds1,a

In patients with refractoriness to platelet transfusions, with or without antibodies to platelets.

Efficacy of treatment regimens in all bleeding episodes

Efficacy in patients with refractoriness and/or antibodiesb

Efficacy of treatment regimens in all bleeding episodes

Efficacy in patients with refractoriness and/or antibodiesb

Methodology: Adjudicator-assessed effectiveness of treatment regimens in patients with GT (N=218) in all severe bleeding episodes and all surgical procedures (N=1073) based on review of Glanzmann’s Thrombasthenia Registry (GTR) data unblinded to investigator-coded efficacy. Efficacy was evaluated on a 2-point scale (clinical assessment of success or failure of treatment regimen as a whole, blinded and unblinded to investigator-coded outcome) including 92 patients treated with NovoSeven® RT for 266 bleeding episodes and 77 patients treated for 160 surgical procedures.1 

Data collected from the GTR and the Hemophilia & Thrombosis Research Society registry showed that 140 patients with GT received NovoSeven® RT for 518 bleeding episodes, surgeries, or traumatic injuries. In the GTR, 1 patient reported a serious adverse reaction (deep vein thrombosis) and 1 patient experienced 3 adverse reactions (nausea, headache, and dyspnea). In addition, 2 patients experienced fever and 1 patient experienced headache.1  


a
Data from a prospective, observational, multinational registry study of patients with GT.1
b
Includes 31 patients (79 episodes) with refractoriness and/or platelet-specific antibodies, 8 patients (10 episodes) with platelet-specific antibodies only, and 57 patients (177 episodes) with neither refractoriness nor antibodies, or unknown status.1
 

Tab Tailored Dosing

Platelet transfusions.

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

cThe minimum effective dose has not been determined.

Dosing recommendation for Glanzmann’s thrombasthenia.1,c

GLANZMANN’S THROMBASTHENIA
with refractoriness to platelet transfusions, with or without antibodies to platelets

90 mcg/kg

every 2-6 hours

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


cThe minimum effective dose has not been determined.

Tab Infusion time

The rapid infusion time they want.

Because of its low volume, NovoSeven® RT takes 2 to 5 minutes to infuse.

Tab Safety Profile

NovoSeven® RT is manufactured for recombinant safety.

NovoSeven® RT undergoes a rigorous process to ensure safety and purity. Plus, it is the only recombinant bypassing agent not made from human serum or proteins.1 Recombinant manufacturing minimizes the possibility of viral contamination.2  

Tab 3-step reconstitution

Room temperature stable for patients on the go.

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

dPrior 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.

Quick reconstitution can save them time.

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


eCompared with reconstitution using histidine vials.

Approved for surgical use and procedures in patients with Glanzmann's thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets.


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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. 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.