Novo Nordisk

Are you prepared to diagnose this rare bleeding disorder?

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.

GT can be easy to miss

A correct diagnosis is vital.¹

Kali has GT with refractoriness to platelets and uses NovoSeven^® RT.

Glanzmann's thrombasthenia is a rare bleeding disorder characterized by impaired platelet function with symptoms ranging from minimal bruising to potentially fatal hemorrhages.^1-4 Not only does GT affect just ~1 in 1,000,000 people,² it also shares symptoms with other acquired platelet disorders and von Willebrand disease, making diagnosis challenging.^1,4 See if one of your patients may have GT by arming yourself with educational resources concerning the signs, symptoms, and treatment of GT.

Could one of your patients have GT?

Glanzmann's thrombasthenia may present with spontaneous and moderate bleeds.

However, ~26% of bleeds in GT patients are severe.^5,a

View other signs and symptoms
of GT.

^aBased on data from Glanzmann’s Thrombasthenia Registry (GTR).

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.

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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.	Solh T, Botsford A, Solh M. Glanzmann's thrombasthenia: pathogenesis, diagnosis, and current and emerging treatment options. J Blood Med. 2015;6:219-227.
2.	Di Minno G, Coppola A, Di Minno MND, et al. Glanzmann's thrombasthenia (defective platelet integrin alpha(IIb)-beta(3)): proposals for management between evidence and open issues. Thromb Haemost. 2009;102(6):1157-1164.
3.	Nurden AT, Pillois X, Nurden P. Understanding the genetic basis of Glanzmann thrombasthenia: implications for treatment. Exp Rev Hematol. 2012;5(5):487-503
4.	Lambert MP. What to do when you suspect an inherited platelet disorder. Hematology Am Soc Hematol Educ Program. 2011;2011:377-383.
5.	Lapecorella M, Mariani G. Factor VII deficiency: defining the clinical picture and optimizing therapeutic options. Haemophilia. 2008;14:1170-1175.

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