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NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is effective in stopping bleeds in people with congenital factor VII (7) deficiency

  • NovoSeven® RT replaces factor VII Factor VII (7)
    One of the 13 clotting-factor proteins that helps form blood clots.
    during clotting Clotting
    The process of forming into a clot or clots.
    to treat bleeds Bleed
    In hemophilia, a collection of blood in an area, such as a muscle or joint.
    from
    factor VII deficiency Factor VII (7) deficiency
    A rare bleeding disorder in which the blood has low levels of Factor VII. Factor VII is important in the blood-clotting process because it binds to blood cells near the location of an injury and to activated platelets, setting the clotting process in motion.
  • NovoSeven® RT targets the site of the injury to help form a stable clot Clot
    The thickened mass of blood and cells your body forms to stop the bleeding at the place where you have been injured.
What is congenital factor VII deficiency?

Congenital factor VII deficiency Congenital Factor VII (7) deficiency
A bleeding disorder in which there are low levels of Factor VII in the blood.
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 Blood clotting
Also known as coagulation. It is the process of turning some of the elements in the blood into a clot. Blood clotting is the result of a sequence of actions and reactions that involve several different proteins in the blood.
process. When there is not enough factor VII in the blood, clotting can take much longer than normal or may not occur at all.

  • Factor VII deficiency is rare, affecting an estimated 1 in every 300,000 to 500,000 people
  • Mild to moderate factor VII deficiency is marked by increased bleeding after surgery and trauma
  • Severe factor VII deficiency is marked by spontaneous Spontaneous
    Something that happens on its own, for what seems like no reason. For example, spontaneous bleeding does not appear to have a specific cause.
    , severe, and even life-threatening bleeding
What causes congenital factor VII deficiency?

Congenital factor VII deficiency is caused by an abnormal Abnormal
Something that is not normal. For example, abnormal bleeding.
gene Gene
A section of DNA. Each gene on a strand of DNA contains certain genetic traits that have been passed on from parents to child.
that is inherited by a child from both parents.

Who gets congenital factor VII deficiency?

The affected factor VII gene is not linked to either sex. Men and women have an equal chance of being born with factor VII deficiency.

Signs of congenital factor VII deficiency

The most common signs of congenital factor VII deficiency, other than excessive Excessive
Too much of something or more of something than is thought to be normal. For example, too much bleeding.
bleeding after injury or invasive procedures Invasive procedure
Most often referred to as surgery, because the doctor enters the body through an incision to repair damage.
, include:

  • Frequent nosebleeds
  • Bleeding from the gums
  • Very heavy, prolonged menstrual Menstrual
    The menstrual cycle consists of a number of bodily changes associated with the development of an egg and the possibility of pregnancy.
    bleeding
  • Head bleeds in newborns
  • Prolonged bleeding following circumcision Circumcision
    Removal of a man’s foreskin.
  • Intestinal bleeding

Factor VII deficiency can be detected at birth. However, some people with factor VII deficiency grow into adulthood without knowing they have it. The blood test that confirms factor VII deficiency is called a clotting assay Clotting assay
A blood test to determine what specific bleeding disorder a person has, based on a prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT) previously measured.
. It measures the amount of time it takes to create a clot.

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is used for:

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

Side Effects

Use with Other Drugs

Please click here for NovoSeven® RT Prescribing Information and Instructions for Use.

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.

NovoSeven® RT is a prescription medicine. Novo Nordisk provides patient assistance for those who qualify. Please call 1-877-NOVO-777 (1-877-668-6777) to learn more about Novo Nordisk assistance programs.