NovoSeven - Novo Seven - Factor VII Deficiency

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FVII deficiency can be diagnosed at the time of birth if the newborn experiences a head bleed during birth or excessive bleeding during circumcision. However, some people who have FVII deficiency grow into adulthood without knowing they have it.

If an OB/GYN sees that a patient regularly menstruates longer and heavier than others, the doctor may suspect a bleeding disorder of some type and have her tested. Likewise, if a dentist finds that a patient’s gums bleed easily at every visit, the dentist may recommend that they be tested for a bleeding disorder.

The blood test that will confirm FVII deficiency is a test that measures the amount of time it takes to create a clot, called a clotting assay. Indicators of FVII deficiency include a prolonged prothrombin time (PT), which is the time it takes for prothrombin to turn into thrombin during the clotting process, and a normal activated partial thromboplastin time (aPTT), which measures the time it takes for a clot to be formed after the activation of FXII in the clotting process.

People With Mild or Moderate FVII Deficiency:

			Have 2-10% of the normal level of FVII

			May or may not experience spontaneous bleeding episodes of any kind

People With Severe FVII Deficiency:

			Have less than 2% of the normal level of FVII

			May experience spontaneous bleeding episodes similar to someone with hemophilia

IMPORTANT SAFETY INFORMATION

NovoSeven® was studied in 298 patients with hemophilia A or B with inhibitors treated for 1939 bleeding episodes.

The most common side effects in people taking NovoSeven were fever, bleeding, a decrease in the amount of coagulation factor 1, pain from blood collecting in a joint, and high blood pressure
People who have ever had a bad reaction to proteins from mice, hamsters, or "bovines" (such as an ox or cow) should not be treated with NovoSeven
After taking NovoSeven, some patients have more of a risk of thrombosis, which is when a clot forms in a blood vessel and causes harm. Although the extent of this risk is not known, it is thought to be small. Some patients have conditions that may increase this risk. These include clogged arteries, blood clots that form throughout the body instead of at the place of injury, a type of blood poisoning called septicemia, and crush injury, which is when a body part is crushed or squeezed between heavy or immobile objects. Also, people taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) at the same time that they're taking NovoSeven may be at increased risk for thrombosis.
Serious adverse events which may or may not have been related to the use of NovoSeven occurred in 14 of the 298 patients in the initial clinical program. Please see the enclosed prescribing information.
There have been no reports of NovoSeven causing bad reactions to "analgesics" (such as pain killers), "antibiotics" (the drugs used to treat infection), or "sedatives" (sleeping pills or tranquillizers).
Development of antibodies against Factor VII have been reported in Factor VII deficient patients after treatment with NovoSeven. These patients had previously been treated with human plasma and/or plasma-derived factor VII.

Development of antibodies against Factor VII has been reported in Factor VII-deficient patients after treatment with NovoSeven. These patients had previously been treated with human plasma and/or plasma-derived Factor VII.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

NovoSeven is a registered trademark of Novo Nordisk Health Care AG.

130601R1 June 2008

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