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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.
Success Speaks for Itself | Hospital Series
The Key Words with Acquired Hemophilia? Early Detection
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
Explore this clinical pathway and patient case study to help you be prepared to more quickly diagnose and treat your patients.a
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.
Explore the Clinical Pathway
Scroll down to learn more about aquired hemophilia
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.
Key facts about acquired hemophilia
| Nearly 52% of AH cases are idiopathic1
| Extremely rare— affecting only 1.5 per million people annually3
| 70% of patients experience severe bleeds at the time of diagnosis1
Nearly 52% of AH cases are idiopathic1
Extremely rare— affecting only 1.5 per million people annually3
70% of patients experience severe bleeds at the time of diagnosis1
For treating severe bleeds there's NovoSeven® RT
NovoSeven® RT is the only FDA-approved bypassing agent in treating AH.4,5
See the Data
Stay tuned for more information about NovoSeven® RT, as part of the Success Speaks for Itself Series.
To learn more right away, schedule a call with your Hemophilia Institutional Account Manager.
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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. | 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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