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?

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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

WARNING: BLOOD CLOTS

  • 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.

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is 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 people with Glanzmann’s thrombasthenia who have 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

WARNING: BLOOD CLOTS

  • 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.

Warnings and Precautions

  • NovoSeven® RT should be used with caution if you have an increased risk for blood clots, such as with disseminated intravascular coagulation (DIC), clogged arteries, crush injury, septicemia (an infection in the blood), uncontrolled bleeding after giving birth, history of heart disease, liver disease, limited movement following surgery, in elderly people, in newborns, or if you are taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) with NovoSeven® RT.
  • Allergic reactions, including serious whole body allergic reactions, have been reported with NovoSeven® RT. Tell your healthcare provider if you are allergic to NovoSeven® RT, any of its ingredients, or mice, hamsters, or cows. If you think you are having an allergic reaction, call your healthcare provider right away. Some signs of allergic reaction may include shortness of breath, rash, itching, redness of the skin, and fainting/dizziness.
  • People with Factor VII deficiency should be monitored by their healthcare provider for antibodies, which can cause NovoSeven® RT to stop working properly.

Side Effects

  • 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.

Use with Other Drugs

  • Blood clots may occur if NovoSeven® RT is given with Coagulation Factor XIII (13).

Please click here for Prescribing Information.

NovoSeven® RT is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.