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Hemophilia With Inhibitors Factor VII Deficiency Acquired Hemophilia Surgery Information About NovoSeven Recombinant Safety SevenSECURE
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Overview
What Is Hemophilia?
What Causes Hemophilia?
What Are the Symptoms?
Blood Basics
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What is Hemophilia?
Hemophilia is a bleeding disorder that prevents blood from clotting properly. Clotting is what makes bleeding stop, because the clot acts like a plug at the site of the injury. When someone bleeds, the body has the ability to stop the bleeding by forming a clot—so that healing can begin. But people with hemophilia might need to see a doctor or use special treatment to make their blood clot. While minor cuts and scrapes can probably be cared for through standard first aid, it’s the bleeding inside the body—into muscles and joints—that is the biggest worry to people with hemophilia. For more information about blood clotting, click here.
Types of Hemophilia
In the blood, there are 13 proteins called clotting factors that work together in a series of steps during the blood-clotting process. There are two main types of hemophilia:
People with hemophilia A (also called "classical hemophilia")
don't have enough, or any, of clotting factor VIII (factor 8)
People with hemophilia B (also called "Christmas disease")
don't have enough, or any, of clotting factor IX (factor 9)
Levels of Severity
In all types of hemophilia, there are 3 levels of severity, which depend on how much of a particular clotting factor occurs naturally in the blood. Normal levels of factor VIII or factor IX vary from 50%–150%. The levels of severity are: mild, moderate, and severe.
Mild: The amount of the particular clotting factor in the blood is between 6% and 49% of normal levels. The bleeding problems that this person will likely experience would occur after a major injury or surgery. These patients may, at times, not be diagnosed until adulthood due to the infrequency of major bleeding episodes.
Moderate: The amount of the particular clotting factor in the blood is between 1% and 5% of normal levels. This person may experience more than usual bleeding following a minor injury or surgery. Bleeding into joints is also possible.
Severe: The amount of a particular clotting factor is less than 1% of normal levels. People with severe hemophilia will experience bleeding more often and for longer than expected after a minor injury. They often experience spontaneous bleeding episodes for what seems to be no apparent reason. Bleeding typically occurs in the joints and muscles. Severe hemophilia is usually diagnosed in the first year of life.

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.
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
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