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NovoSeven® RT (coagulation Factor VIIa, recombinant) logo
Important Safety Information | Patient Site
Prescribing Information
    • Why NovoSeven® RT?
    • Pharmacology
    • Congenital Hemophilia A & B with Inhibitors
    • Acquired Hemophilia
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NovoSeven® RT (coagulation Factor VIIa, recombinant) logo

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, Glanzmann’s thrombasthenia with refractoriness to platelet transfusions and in adults with acquired hemophilia.

Prescribing Information
Important Safety Information | Patient Site

Education for you

Novo Nordisk provides professional educational materials to download or share with colleagues.

Education for you

Novo Nordisk provides professional educational materials to download or share with colleagues.

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Videos

Prescribing Information | Important Safety Information
NovoSeven® RT Glanzmann’s Thrombasthenia (GT) Day Webinar
(59:42)
NovoSeven® RT Glanzmann’s Thrombasthenia (GT) Day Webinar
This webinar includes a panel discussion with leading experts in the field and a first-hand story from someone living with GT.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT for Effective Bleed Control: A Patient Shows Signs of Newly Developed Inhibitors
(7:24)
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NovoSeven® RT for Effective Bleed Control: A Patient Shows Signs of Newly Developed Inhibitors
Dr Lisa Boggio, a hematologist at Rush University, shares how her hospital team treated a hemophilia patient who arrived displaying signs of inhibitors but wasn’t aware of how to self-infuse.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT for Effective Bleed Control: A Glanzmann’s Thrombasthenia Patient Regains Her Autonomy
(9:04)
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NovoSeven® RT for Effective Bleed Control: A Glanzmann’s Thrombasthenia Patient Regains Her Autonomy
Angela Kellum, a hospital pharmacist at Tulane University School of Medicine, was part of a team that helped develop a comprehensive treatment plan for a patient with Glanzmann’s Thrombasthenia.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Mechanism of Action in CHwI
(7:19)
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NovoSeven® RT Mechanism of Action in CHwI
See how NovoSeven® RT works at the site of vascular injury, when used in the treatment of congenital hemophilia with inhibitors (CHwI).
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT MixPro® Reconstitution Video
(8:41)
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NovoSeven® RT MixPro® Reconstitution Video
A patient-friendly overview on reconstituting a dose of NovoSeven® RT with MixPro®.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Surgery in Patients with CHwI
(10:12)
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NovoSeven® RT Surgery in Patients with CHwI
Dr. Miguel Escobar presents the factors to consider before, during and after surgery in a patient with congenital hemophilia with inhibitors (CHwI), along with MASAC recommendations.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Challenges of Treating Glanzmann's Thrombasthenia
(12:14)
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NovoSeven® RT Challenges of Treating Glanzmann's Thrombasthenia
Dr. Meera Chitlur explores diagnosing Glanzmann’s thrombasthenia, and the roles of platelet transfusions and rFVIIa in treating emergent bleeds.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Recognizing Rare Bleeding Disorders in Girls & Women
(37:17)
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NovoSeven® RT Recognizing Rare Bleeding Disorders in Girls & Women
Dr. Michael Paidas discusses how to recognize signs and symptoms of rare bleeding disorders in girls and women, as well as diagnostic tests and treatment options.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Clinical Pathway for Treating Patients with AH
(9:00)
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NovoSeven® RT Clinical Pathway for Treating Patients with AH
Dr. Shannon Carpenter and Dr. Jesse Pines discuss the value of having a clinical pathway in place for identifying and treating patients with acquired hemophilia (AH).
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Clinical Pathway for Patients with CHwI with Emergent Bleeds
(8:54)
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NovoSeven® RT Clinical Pathway for Patients with CHwI with Emergent Bleeds
Dr. Shannon Carpenter and Dr. Jesse Pines discuss the value of having a clinical pathway in place for patients with congenital hemophilia with inhibitors (CHwI) with emergent bleeds.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Clinical Pathway for Patients with CHwI in Surgery
(8:43)
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NovoSeven® RT Clinical Pathway for Patients with CHwI in Surgery
Dr. Shannon Carpenter and Dr. Jesse Pines discuss the value of having a clinical pathway in place for surgery in patients with congenital hemophilia with inhibitors (CHwI).
Watch video
Prescribing Information | Important Safety Information

Audio

(14:41)
Prescribing Information | Important Safety Information
NovoSeven® RT Clinical Management of Acute Bleeds in Patients with CHwI
NovoSeven® RT Clinical Management of Acute Bleeds in Patients with CHwI
14:41
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NovoSeven® RT Clinical Management of Acute Bleeds in Patients with CHwI
Dr. Sandeep Rajan discusses clinical management of acute bleeds in patients with congenital hemophilia with inhibitors.
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Prescribing Information | Important Safety Information
(23:18)
Recognizing Rare Bleeding Disorders
Recognizing Rare Bleeding Disorders
23:18
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Recognizing Rare Bleeding Disorders
Dr. Miguel Escobar discusses how hematologists and oncologists can diagnose and treat unexplained bleeds in patients with acquired hemophilia.
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(19:11)
Bleeding Disorder Diagnosis and Treatment for OBGYNs Part 1
Bleeding Disorder Diagnosis and Treatment for OBGYNs Part 1
19:11
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Bleeding Disorder Diagnosis and Treatment for OBGYNs Part 1
In the first of two presentations on rare bleeding disorders in girls and women, Dr. Michael Paidas and Dr. Ayesha Zia discuss how to recognize important signs and symptoms.
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(18:09)
Bleeding Disorder Diagnosis and Treatment for OBGYNs Part 2
Bleeding Disorder Diagnosis and Treatment for OBGYNs Part 2
18:09
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Bleeding Disorder Diagnosis and Treatment for OBGYNs Part 2
In the 2nd presentation in the series, Dr. Joanna Davis and Dr. Michael Paidas discuss complications associated with postpartum hemorrhaging and acquired hemophilia.
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(26:39)
Prescribing Information | Important Safety Information
NovoSeven® RT Challenges of Diagnosing and Managing Patients With GT
NovoSeven® RT Challenges of Diagnosing and Managing Patients With GT
26:39
NovoSeven® RT Challenges of Diagnosing and Managing Patients With GT
Dr. Meera Chitlur explores diagnosing Glanzmann’s thrombasthenia, and the roles of platelet transfusions and rFVIIa in treating emergent bleeds.
Listen
Prescribing Information | Important Safety Information

Resources

NovoSeven® RT Professional Brochure
PDF
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NovoSeven® RT Professional Brochure
A reference for clinical data across its indicated bleeding disorders, including use in surgical settings.
Download
Prescribing Information | Important Safety Information

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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.

Rare Bleeding Disorders
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