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Clinical Pathway for emergent bleeding in patients with congenital hemophilia.

Clinical Pathway for emergent bleeding in patients with congenital hemophilia.

This algorithm is meant to raise awareness of common steps for treating emergent bleeds in the emergency department (ED) setting.a Review the journey and patient case study that follows the same steps.

This algorithm is meant to raise awareness of common steps for treating emergent bleeds 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 does not constitute guidance for medical advice or treatment.

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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

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 Prescribing Information including boxed Warning.

References:

  1. Centers for Disease Control and Prevention. Hemophilia. https://www.cdc.gov/ncbddd/hemophilia/inhibitors.html. September 6, 2018. Accessed February 4, 2021.
  2. National Hemophilia Foundation. Guidelines for emergency department management of individuals with hemophilia and other bleeding disorders, #257. New York, NY: National Hemophilia Foundation; 2019.
  3. Riley L, Womack M, Zappa S. Emergency Room Care. In Nurses' guide to bleeding disorders. New York, NY: National Hemophilia Foundation; 2012.
  4. Berntorp E, Shapiro A, Astermark J, et al. Inhibitor treatment in haemophilias A and B: summary statement for the 2006 international consensus conference. Haemophilia. 2006;12(suppl 6):1-7.
  5. DiMichele DM. Inhibitors in Hemophilia: A Primer. 4th ed. Montréal, Québec, Canada: World Federation of Hemophilia; 2008:1-9.
  6. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #263. New York, NY: National Hemophilia Foundation; 2020.
  7. National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (Hemlibra®) for hemophilia A with and without inhibitors, #258. New York, NY: National Hemophilia Foundation; 2020.
  8. Center for Disease Control and Prevention. Hemophilia Treatment Center (HTC) Directory. https://www2a.cdc.gov/ncbddd/htcweb/Dir_Report/Dir_Search.asp. Accessed September 18, 2019.
  9. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  10. Lentz SR, Ehrenforth S, Abdul Karim F, et al; adept™2 investigators. Recombinant factor VIIa analog in the management of hemophilia with inhibitors: results from a multicenter, randomized, controlled trial of vatreptacog alfa. J Thromb Haemost. 2014;12(8):1244-1253.