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| 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. |
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| Success Speaks for Itself | Hospital Series |
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The Key Words with Acquired Hemophilia? Early Detection
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Unlike congenital hemophilia, acquired hemophilia (AH) can equally affect males and females. It is more prevalent in older patients and postpartum women.1 EARLY DIAGNOSIS is key to avoid putting patients at higher risk of severe bleeds.2
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Explore this clinical pathway and patient case study to help you be prepared to more quickly diagnose and treat your patients.a
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aThis hypothetical example is for demonstrative purposes only and is not intended to represent a recommended algorithm for actual decision making. This example does not constitute guidance for medical advice or treatment.
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Scroll down to learn more about aquired hemophilia
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| Selected Important Safety Information |
| WARNING: THROMBOSIS |
| • |
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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| Key facts about acquired hemophilia |
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Nearly 52% of AH cases are idiopathic1
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Extremely rare— affecting only 1.5 per million people annually3
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70% of patients experience severe bleeds at the time of diagnosis1
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Nearly 52% of AH cases are idiopathic1
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Extremely rare— affecting only 1.5 per million people annually3
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70% of patients experience severe bleeds at the time of diagnosis1
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For treating severe bleeds there's NovoSeven® RT
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NovoSeven® RT is the only FDA-approved bypassing agent in treating AH.4,5
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| Have you created an account on novoMEDLINK™? |
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| Keep up with important information about treatments for rare bleeding disorders. |
| Receive the latest news about rare bleeding disorders from Novo Nordisk. |
| Download, order, and share educational materials for you and your patients. |
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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. |
Knoebl P, Marco P, Baudo F, et al; EACH2 Registry Contributors. Demographic and clinical data in acquired hemophilia A: results from the European Acquired Haemophilia Registry (EACH2). J Thromb Haemost. 2012;10(4):622-631. |
| 2. |
Collins PW. Therapeutic challenges in acquired factor VIII deficiency. Hematology Am Soc Hematol Educ Program. 2012;2012:369-374. |
| 3. |
Kruse-Jarres R, Kempton C, Baudo F et al. Acquired hemophilia A: Updated review of evidence and treatment guidance. Am J Hematol. 2017;92:695-705. |
| 4. |
NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020. |
| 5. |
OBIZUR [package insert]. Westlake Village, CA: Baxalta US Inc; 2021. |
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