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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
Daily Considerations
Possible Complications
Joint Health
Common Treatment Options
Daily Activities
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Joint Health
In people with severe FVII deficiency, the joints can be the most common sites for bleeding—especially the knees, ankles, and elbows. The bleeding, called hemarthrosis, occurs inside the joint, where there are many tiny blood vessels called capillaries. Bleeds can be a result of rough activity like running or climbing, but sometimes there is no known cause. It is very important to recognize and treat joint bleeding as quickly as possible to prevent permanent damage to the joint.
Repeated bleeding, especially bleeding that happens for a long time, can weaken the joint and the muscles around it. Over time, some cartilage can actually wear away from the joint, making range of motion very limited. A doctor will test the range of motion at every appointment. When the range of motion is permanently limited, it is called joint arthropathy.
Keeping joints healthy can help people who have severe FVII deficiency prevent long-term damage associated with repeated bleeding episodes. Exercise and healthy eating are great ways to practice joint health.
Exercise and physical activity can help8:
Make muscles stronger, which helps prevent bleeding into joints
Maintain balance, which will help prevent injuries from falling
Keep a healthy weight by burning calories, which means less stress on lower joints

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.
© 2008 Novo Nordisk Inc. All Rights Reserved 130601R1 June 2008
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Hemophilia With Inhibitors Factor VII Deficiency Surgery Information About NovoSeven Recombinant Safety SevenSECURE