Clinical Pathway for patients with acquired hemophilia.
Clinical Pathway for patients with acquired hemophilia.
This algorithm is meant to raise awareness of common steps for treating acquired hemophilia in the emergency department (ED) setting.a Review the journey and patient case study that follows the same steps.
aThe provided example is for discussion purposes only and is not intended to represent a recommended algorithm for actual decision making. This example and the accompanying patient case study are for illustrative purposes and do not constitute guidance for medical advice or treatment.
This algorithm is meant to raise awareness of common steps for treating acquired hemophilia in the emergency department (ED) setting.a Review the journey and patient case study that follows the same steps.
aThe provided example is for discussion purposes only and is not intended to represent a recommended algorithm for actual decision making. This example and the accompanying patient case study are for illustrative purposes and do not constitute guidance for medical advice or treatment.
Have questions about the clinical pathway or patient case study?
Need dosing information for acquired hemophilia patients?
Approved for bleed management and surgical use in acquired hemophilia.
Learn more about the signs and symptoms of acquired hemophilia.
Selected Important Safety Information for NovoSeven® RT
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
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
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
- 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 NovoSeven® RT Prescribing Information, including Boxed Warning.
- Shander A, Walsh CE, Cromwell C. Acquired hemophilia: a rare but life-threatening potential cause of bleeding in the intensive care unit. Intensive Care Med. 2011;37(8):1240-1249.
- 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.
- Delgado J, Jimenez-Yuste V, Hernandez-Navarro F, Villar A. Acquired hemophilia: review and meta-analysis focused on therapy and prognostic factors. Br J Haematol. 2003;121(1):21-35.
- 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.
- NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
- Sumner MJ, Geldziler BD, Pedersen M, Seremetis S. Treatment of acquired haemophilia with recombinant activated FVII: a critical appraisal. Haemophilia. 2007;13(5):451-461.