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Important Safety Information | | | Prescribing Information
Indicated for congenital hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelets, and acquired hemophilia. See full indication below.
Diagnosing and Treating Glanzmann’s Thrombasthenia (GT) A NovoSeven® RT Educational Series for Healthcare Professionals
Have you considered testing von Willebrand (vWD) patients for GT?
“I was diagnosed with von Willebrand as a kid, but my symptoms persisted. Years later, I finally got my GT diagnosis and could start on an appropriate treatment.“1
GT patients may initially be misdiagnosed with vWD. While receiving treatment for a different bleeding disorder, misdiagnosed GT patients may continue to experience symptoms such as epistaxis and severe menorrhagia.1
While GT and vWD may present with similar symptoms, there are clear distinctions.2 This Diagnostic Algorithm lays out situations where additional testing of non-responsive vWD patients may provide more clarity.
Try the Diagnostic Algorithm
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
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
Please click here or scroll below for additional Important Safety Information.
Learn more about a treatment option for GT with refractoriness to platelets: NovoSeven® RT. Watch your inbox for more information about GT resources, diagnosis, and treatment.
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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 (cont’d)
Warnings and Precautions
• | 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 Prescribing Information, including boxed Warning.
References:
1. | Doherty D, Singleton E, Byrne M, et al. Missed at first Glanz: Glanzmann thrombasthenia initially misdiagnosed as Von Willebrand Disease. Transfus Apher Sci. 2019;58(1):58-60.
2. | Lambert MP. What to do when you suspect an inherited platelet disorder. Hematology Am Soc Hematol Educ Program. 2011;2011:377-383.
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