Skip to main content

Bypass therapy recommendations for patients with inhibitors.

Patients with congenital hemophilia A or B with inhibitors (CHAwI or CHBwI) are twice as likely to be hospitalized for a bleeding complication.1 NovoSeven® RT is listed among recommended bypassing agents to stop bleeds.2

patient with congenital hemophilia with inhibitors in hospital bed

A first-line treatment option for CHAwI.

important icon

Patients receiving emicizumab prophylaxis can still experience breakthrough bleeds and will need concomitant use of alternate hemostatic therapies.3,a

MASAC recommends rFVIIa as a first option to treat acute bleeding episodes in patients on emicizumab—aPCC should be avoided if possible.3

aPlease refer to the full MASAC recommendations document #255 from December 6, 2018 for full guidance around treatment of bleeding episodes and surgery.

Additional MASAC recommendations for CHwI.

Surgical management with emicizumab: Emicizumab will improve but not normalize hemostasis during surgery, so emicizumab alone should not be presumed as adequate for major procedures.

surgical management with emicizumab

rFVIIa should be provided to patients pre- and post-operatively at the discretion of the treating physician.3,a

Safe for your CHBwI patients: NovoSeven® RT is the only bypassing agent not made with any other coagulation factors, such as FIX or FIXa.4,5

safe for your CHBwI patients

MASAC recommends patients with congenital hemophilia B with a history of inhibitors and anaphylaxis not be given FIX-containing products unless bleeding is life-threatening.6

child patient in hospital talking with healthcare provider

Approved for bleed management

and surgical use in congenital

hemophilia with inhibitors.


NovoSeven® RT (coagulation Factor VIIa, recombinant) dosage vials

Looking for dosing for surgical

use and procedures?


clinical pathway for treating emergent bleeds and acquired hemophilia in emergency department

Review an example of treating

hemophilia with inhibitors in

the emergency department.

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

References:

  1. Centers for Disease Control and Prevention. Hemophilia. https://www.cdc.gov/ncbddd/hemophilia/inhibitors.html. September 6, 2018. Accessed August 2, 2019.
  2. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #253. New York, NY: National Hemophilia Foundation; 2018.
  3. National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (hemlibra®) for hemophilia a with and without inhibitors. MASAC Document #255. 2018.
  4. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2018.
  5. FEIBA [package insert]. Westlake Village, CA: Baxalta US Inc; 2017.
  6. National Hemophilia Foundation. Guidelines for emergency department management of individuals with hemophilia and other bleeding disorders, #252. New York, NY: National Hemophilia Foundation; 2017.