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An effective therapy option for you.

NovoSeven® RT is the only recombinant treatment indicated for Glanzmann's thrombasthenia (GT) with refractoriness to platelets.

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What is GT?

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There are proteins on the platelets that help your blood clot properly. One type of these proteins is a glycoprotein called IIb/IIIa, which helps platelets connect to each other. Those platelets stick together to form a "plug" that stops a bleed. Someone with GT has specific defective glycoprotein IIb/IIIa. This means the platelets cannot form a plug to stop a bleed.
 

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Who gets GT?

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GT is a rare genetic disorder that affects about 1 in 1 million people. It is inherited from both parents and can occur in both men and women.
 

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What are the signs of GT?

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Those with GT mainly have skin and mucous membrane types of bleeding. The most common signs of GT include:

  • Easy bruising
  • Bleeding from the nose or gums
  • Heavy menstruation

Other signs and symptoms include:

  • Excessive bleeding after trauma or surgery
  • Excessive bleeding after dental extractions
     
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What are some treatments for GT?

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One treatment option for GT is platelet transfusion; some patients who receive platelet transfusions may develop antibodies and become resistant. You may be able to use a bypassing agent to control your bleeds if platelets do not work for you.

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Selected Important Safety Information

What is the most important information I should know about NovoSeven® RT?

NovoSeven® RT may cause serious side effects, including:

  • Serious blood clots that form in veins and arteries with the use of NovoSeven® RT have been reported
  • Your healthcare provider should discuss the risks and explain the signs and symptoms of blood clots to you. Some signs of a blood clot may include pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, shortness of breath, or sudden severe headache and/or loss of consciousness or function
  • Your healthcare provider should monitor you for blood clots during treatment with NovoSeven® RT

What is NovoSeven® RT?

NovoSeven® RT (coagulation Factor VIIa, recombinant) is an injectable medicine used for:

  • Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with a decreased or absent response to platelet transfusions
  • Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia

Important Safety Information

What is the most important information I should know about NovoSeven® RT?

NovoSeven® RT may cause serious side effects, including:

  • Serious blood clots that form in veins and arteries with the use of NovoSeven® RT have been reported
  • Your healthcare provider should discuss the risks and explain the signs and symptoms of blood clots to you. Some signs of a blood clot may include pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, shortness of breath, or sudden severe headache and/or loss of consciousness or function
  • Your healthcare provider should monitor you for blood clots during treatment with NovoSeven® RT
  • You should not use NovoSeven® RT if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reactions (anaphylaxis) to NovoSeven® RT, any of its ingredients, or mice, hamsters, or cows. Signs of allergic reaction include shortness of breath, rash, itching (pruritus), redness of the skin (erythema), or fainting/dizziness

What should I tell my healthcare provider before using NovoSeven® RT?

  • Tell your healthcare provider if you have any of the following, as these may increase your risk of blood clots:
    • congenital hemophilia and are also receiving treatment with aPCCs (activated prothrombin complex concentrates)
    • are an older patient particularly with acquired hemophilia and receiving other agents to stop bleeding
    • history of heart or blood vessel diseases
  • Tell your healthcare provider and pharmacist about all the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies

What are the possible side effects of NovoSeven® RT?

  • The most common and serious side effects are blood clots
  • Tell your healthcare provider about any side effects that bother you or do not go away, and seek medical help right away if you have signs of a blood clot or allergic reaction

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