Living with congenital factor VII deficiency?

NovoSeven® RT has the proven effectiveness you expect from your treatment.

Living with congenital factor VII deficiency?

NovoSeven® RT has the proven effectiveness you expect from your treatment.

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What is congenital factor VII deficiency?

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Congenital factor VII deficiency is a 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 congenital factor VII deficiency is marked by increased bleeding after surgery and trauma
  • Severe congenital factor VII deficiency is marked by spontaneous, severe, and even life-threatening bleeding
     
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Who gets congenital factor VII deficiency?

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

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The most common signs of congenital factor VII deficiency, 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

Congenital factor VII deficiency can be detected at birth. However, some people with congenital factor VII deficiency 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

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.