Glanzmann's
thrombasthenia
Dallas has
Glanzmann’s
Thrombasthenia with
refractoriness to
platelet transfusions
Glanzmann's
thrombasthenia
Glanzmann's
thrombasthenia
Dallas has
Glanzmann’s
Thrombasthenia with
refractoriness to
platelet transfusions
NovoSeven® RT is the only FDA-approved recombinant bypassing agent for patients with Glanzmann's thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets.1,2
NovoSeven® RT is proven effective in perioperative management in GT patients with refractoriness to platelet transfusions, with or without antibodies to platelets.1 To learn more about diagnosing and treating GT in hospitals, see this diagnostic algorithm.
All surgical procedures1
n=77; 160 bleeding events
Established safety profile
Patient registries show a low rate of thrombotic events
Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance.1 In patient registries, a <0.2% rate of thrombotic events have been reported in patients with Glanzmann’s thrombasthenia.1,a
Data from registry data1
Occurrence of thrombotic events
aPatients with Glanzmann’s thrombasthenia (N=140) 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
NovoSeven® RT is manufactured with safety in mind.
NovoSeven® RT is made without human serum or human proteins. Recombinant manufacturing minimizes the possibility of viral contamination.1,3
Study design
Glanzmann’s Thrombasthenia Registry (GTR):
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.
Find the dose for your patients with GT.*
*As a reminder, for US health care professionals only.
Learn more about diagnosing Glanzmann’s thrombasthenia.
Find resources that can help your patients with GT.
Selected Important Safety Information for NovoSeven® RT
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
- Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events
Indications and Usage
NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for:
- Treatment of bleeding episodes and perioperative 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 perioperative 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
- Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events
- Hypersensitivity reactions, including anaphylaxis, can occur with NovoSeven® RT. Patients with a known hypersensitivity to mouse, hamster, or bovine proteins may be at a higher risk of hypersensitivity reactions. Discontinue infusion and administer appropriate treatment when hypersensitivity reactions occur
- 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 NovoSeven® RT Prescribing Information, including Boxed Warning.
References
- NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
- Poon MC, Di Minno G, d’Oiron R, et al. New insights into the treatment of Glanzmann thrombasthenia. Transfus Med Rev. 2016;30(2):92-99.
- National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #263. New York, NY: National Hemophilia Foundation; 2020.