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Effective bleed control for people with acquired hemophilia.

NovoSeven® RT is the only bypassing agent that is approved by the FDA for acquired hemophilia.

Effective bleed control for people with acquired hemophilia.

NovoSeven® RT is the only bypassing agent that is approved by the FDA for acquired hemophilia.

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What is acquired hemophilia (AH)?

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Acquired hemophilia is a bleeding disorder that prevents blood from clotting properly. Unlike congenital hemophilia, which is an inherited disorder, acquired hemophilia is not present at birth; it develops suddenly. When a person develops acquired hemophilia:

  • Their body develops antibodies, or "inhibitors," that fight its own blood-clotting factors, mostly factor VIII
  • Spontaneous, uncontrolled bleeding can occur
     
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Who gets acquired hemophilia?

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Acquired hemophilia occurs in people with no personal or family history of bleeding disorders. It is very rare, occurring in only about 1 to 1.5 per million people each year. It usually affects older people, as well as women who have recently given birth.

Acquired hemophilia can occur in association with other underlying conditions that involve the immune system, like cancer, other autoimmune diseases, or pregnancy. In about half of cases, there is no clear medical condition or reason that it happens.
 

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What are the symptoms of acquired hemophilia?

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Acquired hemophilia can happen without warning. The most common symptoms are:

  • Bleeding into the skin (bruising)
  • Bleeding into soft tissues
  • Internal bleeding
  • Excessive bleeding following childbirth or surgery

Acquired hemophilia is diagnosed with laboratory tests that measure clotting time of blood and factor VIII levels.
 

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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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