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    Non-US Health Care Professionals
 |  Important Safety Information

NovoSeven® RT (coagulation Factor VIIa, recombinant)

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 thrombastheniaa
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 and surgery 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 Meet Miguel
(15:44)
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NovoSeven® RT Meet Miguel
Miguel, who lives with hemophilia B with an inhibitor, shares how NovoSeven® RT fits into his routine.
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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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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
Prescribing Information | Important Safety Information
NovoSeven® RT Meet Justin
(3:46)
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NovoSeven® RT Meet Justin
Justin, who lives with hemophilia A with an inhibitor, shares his love of travel and how NovoSeven® RT fits in when he’s living life on the go.
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Prescribing Information | Important Safety Information
NovoSeven® RT Hemophilia with Inhibitors Brochure
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NovoSeven® RT Hemophilia with Inhibitors Brochure
Information to help patients with CHwI understand hemophilia and inhibitors and why NovoSeven® RT may be right for them.
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NovoSeven® RT Hemophilia with Inhibitors Brochure – Spanish
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NovoSeven® RT Hemophilia with Inhibitors Brochure – Spanish
Spanish-language information to help patients with CHwI understand hemophilia and inhibitors and why NovoSeven® RT may be right for them.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Meet Bob
(4:01)
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NovoSeven® RT Meet Bob
Bob discusses living with hemophilia A with an inhibitor, and how important he finds the quick infusion time of NovoSeven® RT.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Meet Chase
(4:03)
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NovoSeven® RT Meet Chase
Chase, who lives with hemophilia A with an inhibitor, and his grandmother discuss how the portability of NovoSeven® RT fits into their lives.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Meet Taylor
(3:56)
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NovoSeven® RT Meet Taylor
Taylor, who lives with factor VII deficiency, shares how the quick reconstitution of NovoSeven® RT fits in with her love of travel.
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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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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Meet Kali
(4:11)
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NovoSeven® RT Meet Kali
Kali lives with Glanzmann’s thrombasthenia with resistance to platelets and takes NovoSeven® RT along when she’s on the go.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
NovoSeven® RT Meet Cathy
(7:04)
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NovoSeven® RT Meet Cathy
Cathy, who lives with Glanzmann’s thrombasthenia, shares her story about living with GT and why she chooses NovoSeven® RT.
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Prescribing Information | Important Safety Information
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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Prescribing Information | Important Safety Information
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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Prescribing Information | Important Safety Information
Esperoct® Conversation Starter
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Esperoct® Conversation Starter
A guide for patients with a series of questions, designed to help them determine what’s important in their hemophilia A treatment.
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Prescribing Information | Important Safety Information
Esperoct® Patient Brochure
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Esperoct® Patient Brochure
A patient-friendly resource with detailed information on extended half-life, storage, and other features of Esperoct® as well as available product support.
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Esperoct® Patient Brochure – Spanish
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Esperoct® Patient Brochure – Spanish
A patient-friendly resource with detailed information in Spanish on extended half-life, storage, and other features of Esperoct® as well as available product support.
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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® 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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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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Rebinyn® Patient Brochure – Spanish
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Rebinyn® Patient Brochure – Spanish
A resource for your Spanish-speaking patients, 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® Meet Abdiel
(9:41)
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Rebinyn® Meet Abdiel
Abdiel, who lives with hemophilia B, shares his story of empowering others in the hemophilia community, as well as why he chose to use Rebinyn®.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Rebinyn® Extended Half-life
(8:32)
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Rebinyn® Extended Half-life
A friendly animation that helps patients and caregivers learn about the science behind the extended half-life (EHL) of Rebinyn® and how it compares to standard half-life factor IX products.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Rebinyn® MixPro® Reconstitution Video
(9:50)
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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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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Rebinyn® Meet Emili
(10:37)
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Rebinyn® Meet Emili
Emili, a caregiver for her young son Xander, shares why she chose Rebinyn® to treat his hemophilia B.
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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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website
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Rebinyn® Patient Website – Spanish
Patients who speak Spanish 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
Rebinyn® Meet Markus
(3:50)
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Rebinyn® Meet Markus
Markus, who is 33 years old and lives with hemophilia B, shares his love of the outdoors.
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Novoeight® Conversation Starter
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Novoeight® Conversation Starter
This resource is designed to help patients evaluate their treatment needs and show them how Novoeight® can meet those needs.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Novoeight® Meet Vaughn
(6:23)
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Novoeight® Meet Vaughn
Vaughn shares his story of living with hemophilia A, his passion for staying fit through diet and exercise, and why he values a treatment that he can take with him as he lives his life.
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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
Prescribing Information | Important Safety Information
Novoeight® Meet Tammy
(9:17)
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Novoeight® Meet Tammy
Tammy, who was diagnosed with hemophilia A at the age of 5, shares her story, the lack of awareness around women and bleeding disorders, and her mission to change that.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Novoeight® is Ready to Go
(3:51)
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Novoeight® is Ready to Go
Team Novo8™ member Vaughn shares his experience with Novoeight® and how it fits his active lifestyle.
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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
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
Prescribing Information | Important Safety Information
Novoeight® Meet Clyde
(9:08)
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Novoeight® Meet Clyde
Clyde, who lives with severe hemophilia A, shares his story of embracing his bleeding disorder, becoming active in the community and being a good example to 2 nephews who also live with hemophilia.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Novoeight® Meet Brian
(8:00)
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Novoeight® Meet Brian
Brian, who lives with hemophilia A, discusses how he hasn't allowed his bleeding disorder to limit his outdoor activities, and how he helps families living with hemophilia realize that they are not alone.
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Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Novoeight® Meet Daniel
(4:12)
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Novoeight® Meet Daniel
Daniel discusses his journey into adulthood while living with hemophilia A, along with his work with young children and teenagers, helping them deal with the challenges of growing up with hemophilia.
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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

Adverse Reactions

  • The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions

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, including anaphylaxis, may occur. 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 for on demand treatment and control of bleeding episodes and perioperative management of bleeding.

Limitations of Use: Rebinyn® is not indicated for routine prophylaxis or 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, including anaphylaxis, may occur. 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.
  • Development of neutralizing antibodies (inhibitors) to Factor IX may occur. Monitor patients for development of factor IX inhibitors if bleeding is not controlled with the recommended dose of Rebinyn® or if expected Factor IX activity plasma levels are not attained. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • The use of Factor IX-containing products has been associated with thrombotic 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 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 clinical trials (≥1%) were itching and injection site reactions.
  • Animals administered repeat doses of Rebinyn® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown.

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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