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 |  Important Safety Information

NovoSeven® RT (coagulation Factor VIIa, recombinant)

Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, 300 mg pens

Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei]

Novoeight® (antihemophilic factor, recombinant)

Rebinyn® coagulation factor IX (recombinant), glycoPEGylated

Tretten® (coagulation factor XIII A-subunit [recombinant])

Product resources library

Explore our library of bleeding disorder treatment education for healthcare professionals, including mechanisms of action, patient case studies and therapy options.

NovoSeven® RT (coagulation Factor VIIa, recombinant)
For bleed treatment and surgery in congenital hemophilia A or B with inhibitors, acquired hemophilia, congenital factor VII deficiency, and Glanzmann's thrombasthenia.a
Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei]
For on-demand bleed control, surgery and routine prophylaxis in adults and children with hemophilia A.
Rebinyn® coagulation factor IX (recombinant), glycoPEGylated
For on demand bleed control, surgery, and routine prophylaxis in adults and children with hemophilia B.
Novoeight® (antihemophilic factor, recombinant)
For on-demand bleed control, surgery and routine prophylaxis in adults and children with hemophilia A.

aWith refractoriness to platelet transfusions, with or without antibodies to platelets.

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Prescribing Information | Important Safety Information
NovoSeven® RT Glanzmann’s Thrombasthenia (GT) Day Webinar
(59:42)
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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

NovoSeven® RT: 30+ years of research and clinical experience.

Vial of NovoSeven® RT (coagulation Factor VIIa, recombinant)
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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 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
(17.07)
Prescribing Information | Important Safety Information
NovoSeven® RT Surgery Considerations for Patients with CHwI and AH
NovoSeven® RT Surgery Considerations for Patients with CHwI and AH
17.07
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NovoSeven® RT Surgery Considerations for Patients with CHwI and AH
Dr Miguel Escobar presents the factors to consider before, during and after surgery in a patient with congenital hemophilia with inhibitors (CHwI), or acquired hemophilia (AH).
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Prescribing Information | Important Safety Information
(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
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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.
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Prescribing Information | Important Safety Information
(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

Considering extended half-life treatment for your hemophilia A patients?

Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] box and prefilled diluent syringe
Explore Esperoct®

Prescribing Information | Important Safety Information

Learn about the efficacy of Rebinyn®, an extended half-life factor IX treatment.

Prefilled Rebinyn® (Coagulation Factor IX [Recombinant], GlycoPEGylated) diluent syringe
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Prescribing Information | Important Safety Information

Portability features of Novoeight® may make it a good fit for your patients with
hemophilia A.

Vial of Novoeight® (Antihemophilic Factor [Recombinant]) prescription
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Prescribing Information | Important Safety Information

Rebinyn® Lab Program Form
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Rebinyn® Lab Program Form
Download this form to activate a Labcorp account and participate in the Novo Nordisk Lab Program. Email the completed form to fixsupport@labcorp.com.
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Prescribing Information | Important Safety Information
Esperoct® HCP Sample Brochure
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Esperoct® HCP Sample Brochure
A brochure that allows for eligible HCPs to receive samples of Esperoct® for appropriate patients.
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Prescribing Information | Important Safety Information
Esperoct® Lab Program Form
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Esperoct® Lab Program Form
Download this form to activate a Labcorp account and participate in the Novo Nordisk Lab Program. Email the completed form to fixsupport@labcorp.com.
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Add to order
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).
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Prescribing Information | Important Safety Information

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.

Selected Important Safety Information for Esperoct®

Contraindications

  • Do not use in patients who have known hypersensitivity to Esperoct® or its components, including hamster proteins

Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate treatment

Indications and Usage

Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes

  • Esperoct® is not indicated for the treatment of von Willebrand disease

Important Safety Information

Contraindications

  • Do not use in patients who have known hypersensitivity to Esperoct® or its components, including hamster proteins

Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate treatment
  • Development of neutralizing antibodies (inhibitors) has occurred. Perform an assay that measures Factor VIII inhibitor concentration if bleeding is not controlled with the recommended dose of Esperoct® or if the expected plasma Factor VIII activity levels are not attained
  • Temporary decrease in Factor VIII incremental recovery (IR) has been observed after Esperoct® infusion, within the first 5 exposure days, in previously untreated patients (PUPs) <6 years of age. During the decreased IR period, these subjects may have an increased bleeding tendency. If bleeding is not controlled with the recommended dose of Esperoct® and/or the expected Factor VIII activity levels are not attained and Factor VIII inhibitors are not detected, consider adjusting the dose, dosing frequency, or discontinuing Esperoct®

Adverse Reactions

  • The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions. Additional frequently reported adverse reactions (≥1%) in PUPs included Factor VIII inhibition and hypersensitivity.

Please click here for Esperoct® Prescribing Information.

Selected Important Safety Information for Novoeight®

Contraindications

  • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins

Warnings and Precautions

  • Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment

Indications and Usage

Novoeight® (antihemophilic factor, recombinant) is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.

  • Novoeight® is not indicated for the treatment of von Willebrand disease

Important Safety Information

Contraindications

  • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins

Warnings and Precautions

  • Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment
  • Development of activity-neutralizing antibodies (inhibitors) may occur. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all factor VIII products. Inhibitors have been reported following administration of Novoeight® in PUPs. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors

Adverse Reactions

  • The most frequently reported adverse reactions (≥1%) were inhibitors in Previously Untreated Patients (PUPs), injection site reactions, and pyrexia.

Please click here for Novoeight® Prescribing Information.

Selected Important Safety Information for Rebinyn®

Contraindications

  • Rebinyn® is contraindicated in patients with a known hypersensitivity to Rebinyn® or its components, including hamster proteins.

Warnings and Precautions

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. Signs may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Discontinue Rebinyn® if allergic- or anaphylactic-type reactions occur and initiate appropriate treatment.

Indications and Usage

Rebinyn®, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. 

Limitations of Use: Rebinyn® is not indicated for immune tolerance induction in patients with hemophilia B.

Important Safety Information

Contraindications

  • Rebinyn® is contraindicated in patients with a known hypersensitivity to Rebinyn® or its components, including hamster proteins.

Warnings and Precautions

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. Signs may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Discontinue Rebinyn® if allergic- or anaphylactic-type reactions occur and initiate appropriate treatment.
  • Inhibitors: The formation of inhibitors (neutralizing antibodies) to Factor IX has occurred following Rebinyn®. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, perform an assay that measures Factor IX inhibitor concentration. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • Thrombotic Events: The use of Factor IX-containing products has been associated with thromboembolic complications. Monitor for thrombotic and consumptive coagulopathy when administering Rebinyn® to patients with liver disease, post-operatively, to newborn infants, or to patients at risk of thrombosis or disseminated intravascular coagulation (DIC).
  • Nephrotic Syndrome: Nephrotic syndrome has been reported following immune tolerance induction therapy with Factor IX products in hemophilia B patients with Factor IX inhibitors, often with a history of allergic reactions to Factor IX. The safety and efficacy of using Rebinyn® for immune tolerance induction have not been established.

Adverse Reactions

  • The most common adverse reactions reported in previously treated patients in clinical trials (≥1%) were itching and injection site reactions. The most common adverse reactions (≥1%) in previously untreated patients reported in clinical trials were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction.
  • Animals administered Rebinyn® showed accumulation of PEG in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons. The potential clinical implications of these animal findings are unknown. Consider whether the patient is vulnerable to cognitive impairment, such as infants and children who have developing brains, and patients who are cognitively impaired.

Please click here for Rebinyn® Prescribing Information.

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