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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 for your patients

Patient-friendly information about our treatments for hemophilia and rare bleeding disorders, including patient stories and instructions for using our MixPro® device.

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.
Tretten® (coagulation factor XIII A-subunit [recombinant])
For routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

AH=acquired hemophilia; CHAwI=congenital hemophilia A with inhibitors; CHBwI=congenital hemophilia B with inhibitors; CFVIId=congenital factor VII deficiency; GT=Glanzmann’s thrombasthenia.

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

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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
NovoSeven<sup>®</sup> RT Patient Website
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NovoSeven® RT Patient Website
Educational resources for patients, including information about NovoSeven® RT, what it treats and how to get started.
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Prescribing Information | Important Safety Information
NovoSeven® RT Factor VII Deficiency Brochure
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NovoSeven® RT Factor VII Deficiency Brochure
A resource designed for patients with CFVIId, with baseline information, signs and symptoms, available treatments and more.
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NovoSeven® RT Factor VII Deficiency Brochure – Spanish
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NovoSeven® RT Factor VII Deficiency Brochure – Spanish
A resource designed for patients with CFVIId who speak Spanish, with baseline information, signs and symptoms, available treatments and more.
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NovoSeven® RT Glanzmann's thrombasthenia (GT) with Refractoriness to Platelets Brochure
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NovoSeven® RT Glanzmann's thrombasthenia (GT) with Refractoriness to Platelets Brochure
Information about GT with refractoriness to platelet transfusions, with or without antibodies to platelets.
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NovoSeven® RT Glanzmann's thrombasthenia (GT) with Refractoriness to Platelets Brochure – Spanish
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NovoSeven® RT Glanzmann's thrombasthenia (GT) with Refractoriness to Platelets Brochure – Spanish
Spanish-language information about GT with refractoriness to platelet transfusions, with or without antibodies to platelets.
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NovoSeven® RT MixPro Fact Sheet
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NovoSeven® RT MixPro Fact Sheet
An overview on how NovoSeven® RT with MixPro® can help patients begin to treat a bleed in just a few steps by using a prefilled syringe to reconstitute.
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NovoSeven® RT Patient Glanzmann's Thrombasthenia Doctor Discussion Guide
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NovoSeven® RT Patient Glanzmann's Thrombasthenia Doctor Discussion Guide
A guide to help patients prepare to discuss Glanzmann’s thrombasthenia-related topics with their health care provider.
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Esperoct<sup>®</sup> Patient Website
website
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Esperoct® Patient Website
Resources to help your patients learn more about Esperoct®, with answers to common questions and reasons for considering Esperoct®.
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Esperoct<sup>®</sup> Patient Website – Spanish
website
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Esperoct® Patient Website – Spanish
Resources to help your patients who speak Spanish learn more about Esperoct®, with answers to common questions and reasons for considering Esperoct®.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Esperoct® MixPro® Reconstitution Video
(7:31)
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Esperoct® MixPro® Reconstitution Video
Patients can learn how to prepare a dose of Esperoct® with the MixPro® syringe. It’s as easy as attach, twist, mix.
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Prescribing Information | Important Safety Information
Rebinyn® Patient Brochure
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Rebinyn® Patient Brochure
A resource with information on the half-life and additional features of Rebinyn®, with product comparisons and more.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Rebinyn® MixPro® Reconstitution Video
(9:22)
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Rebinyn® MixPro® Reconstitution Video
An overview for patients that describes how to reconstitute a dose of Rebinyn® with MixPro®.
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Rebinyn<sup>®</sup> Patient Website
website
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Rebinyn® Patient Website
Patients can learn more about Rebinyn®, including reasons to consider Rebinyn® and how it works.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Novoeight® MixPro® Reconstitution Video
(6:23)
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Novoeight® MixPro® Reconstitution Video
A patient-friendly educational tool demonstrating how to correctly prepare Novoeight® for infusion with the MixPro® prefilled syringe.
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Prescribing Information | Important Safety Information
Novoeight<sup>®</sup> Patient Website
website
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Novoeight® Patient Website
Resources to help patients learn about the features of Novoeight®, with information on storage, support options and more.
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Prescribing Information | Important Safety Information
Novoeight<sup>®</sup> Patient Website – Spanish
website
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Novoeight® Patient Website – Spanish
Resources to help patients who speak Spanish learn about the features of Novoeight®, with information on storage, support options and more.
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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.

Selected Important Safety Information for Tretten®

Tretten® is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

Tretten® may cause allergic reactions. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately and institute appropriate treatment.

Indications and Usage

Tretten® (Coagulation Factor XIII A-Subunit [Recombinant]) is indicated for routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

Tretten® is not for use in patients with congenital Factor XIII B-subunit deficiency.

Important Safety Information

Tretten® is contraindicated in patients with hypersensitivity to the active substance or to any of the exicipients.

Tretten® may cause allergic reactions. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately and institute appropriate treatment.

Thromboembolic complications may occur. Monitor patients with conditions that predispose to thrombosis for signs and symptoms of thrombosis after administration of Tretten®.

Inhibitory antibodies may occur with Tretten®. Patients with inhibitory antibodies may manifest as an inadequate response to treatment. If expected plasma FXIII activity levels are not attained, or if breakthrough bleeding occurs while receiving prophylaxis, perform an assay that measures FXIII inhibitory antibody concentrations.

The most common adverse reactions reported in clinical trials (≥1%) were headache, pain in the extremities, pain at injection site, and increase in fibrin D dimer levels. 

Thrombosis may occur if Tretten® is administered concomitantly with Factor VIIa.

There are no adequate and well-controlled studies using Tretten® in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with Tretten®.

Please click here for Tretten® Prescribing Information.

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