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Hemophilia With Inhibitors Factor VII Deficiency Acquired Hemophilia Surgery Information About NovoSeven Recombinant Safety SevenSECURE
About FVII Deficiency Managing FVII Deficiency Surgery in FVII Deficiency
Overview
What is FVII Deficiency?
What Causes FVII Deficiency?
What Are the Symptoms?
Diagnosing FVII Deficiency
Where Do Bleeds Occur?
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What is FVII Deficiency?
Factor VII deficiency is an inherited rare-bleeding disorder in which there are low levels of FVII present in the blood. FVII plays an important role in the blood-clotting process, so when there isn’t enough of it in the blood, clotting can take much longer than normal or may not occur at all. This results in excessive bleeding, which can be difficult to control and dangerous.
FVII deficiency is considered rare, affecting an estimated one in 500,000 people. Both men and women can be affected. Frequency and severity of bleeding episodes vary from person to person.
Some people with very mild FVII deficiency may not even know they have the condition
Mild to moderate FVII deficiency is characterized by increased bleeding after surgery and trauma13
Severe FVII deficiency is marked by spontaneous, severe, and even life-threatening bleeding13

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.
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Hemophilia With Inhibitors Factor VII Deficiency Surgery Information About NovoSeven Recombinant Safety SevenSECURE