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NovoSeven® RT is indicated for congenital hemophilia A or
B with inhibitors, congenital Factor VII deficiency, Glanzmann’s
thrombasthenia with refractoriness to platelets, and acquired
hemophilia.
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Glanzmann’s thrombasthenia is easy to miss.
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Model is used for illustrative purposes only.
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Glanzmann’s thrombasthenia (GT) shares symptoms with other acquired platelet
disorders and von Willebrand disease.1,2,a
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To give your patients the treatment they need, learn how to
spot the signs
and make the right diagnosis.
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| aNovoSeven® RT is not indicated to treat von Willebrand disease. |
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| Scroll down for more support |
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| Selected Important Safety Information |
| WARNING: THROMBOSIS |
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Serious arterial and venous thrombotic events following administration
of NovoSeven® RT have been reported
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Discuss the risks and explain the signs and symptoms of thrombotic and
thromboembolic events to patients who will receive
NovoSeven® RT
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Monitor patients for signs or symptoms of activation of the coagulation
system and for thrombosis
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| Warnings and Precautions |
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Serious arterial and venous thrombotic events have been reported in clinical trials
and postmarketing surveillance
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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
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Please
click here
or scroll below for additional Important Safety Information.
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Access a diagnostic and treatment algorithm.
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Several tests may be required to confirm a GT diagnosis. Routine test results are
often normal, and specialized tests require an experienced laboratory.1,2
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Your Novo Nordisk representative is ready to walk you through the digital algorithm and treatment considerations for GT.
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| Indications and Usage |
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NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor
indicated for:
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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
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Treatment of bleeding episodes and perioperative management in adults with acquired
hemophilia
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| Important Safety Information (cont’d) |
| Warnings and Precautions |
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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
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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
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Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct
correlation to achieving hemostasis
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| Adverse Reactions |
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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
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| Drug Interactions |
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Thrombosis may occur if NovoSeven® RT is administered
concomitantly with Coagulation Factor XIII
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Please click here for
Prescribing Information including boxed Warning.
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| 1. |
Lambert MP. What to do when you suspect an inherited platelet disorder. Hematology Am Soc Hematol Educ Program. 2011;2011:377-383. |
| 2. |
Solh T, Botsford A, Solh M. Glanzmann's thrombasthenia: pathogenesis, diagnosis, and current and emerging treatment options. J Blood Med. 2015;6:219-227. |
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Novo Nordisk is a registered trademark of Novo Nordisk A/S.
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© 2020 Novo Nordisk All rights reserved. US20NSVN00113 December 2020 |
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