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Living with factor VII deficiency?

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What is FVIId?

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FVIId is a rare bleeding disorder in which there are low levels of factor VII in the blood. Factor VII plays an important role in the blood-clotting process. When there is not enough factor VII in the blood, clotting can take much longer than normal or may not occur at all.

  • Mild to moderate FVIId is marked by increased bleeding after surgery and trauma
  • Severe FVIId is marked by spontaneous, severe, and even life-threatening bleeding
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Who gets FVIId?

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  • Children who inherit an abnormal gene from both parents. Men and women have an equal chance of being born with FVIId
  • FVIId is rare, affecting an estimated 1 in every 300,000 to 500,000 people
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What are the symptoms of FVIId?

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The most common signs of FVIId, other than excessive bleeding after injury or invasive procedures, include:

  • Frequent nosebleeds
  • Bleeding from the gums
  • Very heavy, prolonged menstrual bleeding
  • Head bleeds in newborns
  • Prolonged bleeding following circumcision
  • Intestinal bleeding

FVIId can be detected at birth. However, some people with FVIId grow into adulthood without knowing they have it. The blood test that confirms congenital factor VII deficiency is called a clotting assay. It measures the amount of time it takes to create a clot.

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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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