Take a look around the new novoMEDLINK™ experience.
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access resources for rare bleeding disorders |
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All the resources you need, all in one place.
novoMEDLINK™ is your go-to place for Novo Nordisk products, educational resources and disease state information to help patients with rare bleeding disorders and the people who treat them.
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Help your hospital team stay prepared
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The novoMEDLINK™ website includes tools and resources for you to help patients in the emergency department. See recommendations for managing bleeds in the hospital, including clinical pathways for emergent bleeds and acquired hemophilia, as well as steps for diagnosing and treating Glanzmann’s thrombasthenia.
The novoMEDLINK™ website includes tools and resources for you to help patients in the emergency department. See recommendations for managing bleeds in the hospital, including clinical pathways for emergent bleeds and acquired hemophilia, as well as steps for diagnosing and treating Glanzmann’s thrombasthenia.
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A broad range of products for your patients
Novo Nordisk offers the following recombinant treatments for your appropriate patients with hemophilia and rare bleeding disorders:
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For bleed treatment and surgery in congenital hemophilia A or B with inhibitors, acquired hemophilia, congenital factor VII deficiency and Glanzmann's thrombastheniaa
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For on-demand bleed control, surgery and routine prophylaxis in adults and children with hemophilia A.
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For on demand bleed control, surgery, and routine prophylaxis in adults and children with hemophilia B.
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awith refractoriness to platelets, with or without antibodies to platelets
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Create your account on novoMEDLINK™ |
On novoMEDLINK™, you can request trial prescriptions, order educational materials and access the latest product information across rare bleeding disorders. |
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Important Safety Information for NovoSeven® RT |
WARNING: THROMBOSIS |
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Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported |
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Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT |
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Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis |
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Warnings and Precautions |
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Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance |
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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 |
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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 |
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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 |
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Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis |
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Adverse Reactions |
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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 |
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Drug Interactions |
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Thrombosis may occur if NovoSeven® RT is administered concomitantly with Coagulation Factor XIII |
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Indications and Usage |
NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for: |
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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 . |
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Treatment of bleeding episodes and perioperative management in adults with acquired hemophilia |
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Please click here for Prescribing Information. |
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Important Safety Information |
Contraindications |
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Do not use in patients who have known hypersensitivity to Esperoct® or its components, including hamster proteins |
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Warnings and Precautions |
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Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate treatment |
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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 |
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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® |
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Adverse Reactions |
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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. |
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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 |
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Esperoct® is not indicated for the treatment of von Willebrand disease |
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Please click here for Esperoct® Prescribing Information. |
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Important Safety Information for Rebinyn® |
Contraindications |
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Rebinyn® is contraindicated in patients with a known hypersensitivity to Rebinyn® or its components, including hamster proteins. |
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Warnings and Precautions |
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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. |
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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. |
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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). |
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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. |
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Adverse Reactions |
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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. |
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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. |
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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. |
Please click here for Prescribing Information. |
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Please click on the link to see WAC pricing for the products mentioned above: Product Pricing.
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Esperoct®, NovoSeven®, and Rebinyn® are registered trademarks of Novo Nordisk Health Care AG. novoMEDLINK™ is a trademark of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2024 Novo Nordisk All rights reserved. US23NSVN00070 March 2024
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