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Hemophilia With Inhibitors Factor VII Deficiency Acquired Hemophilia Surgery Information About NovoSeven Recombinant Safety SevenSECURE
About Hemophilia With Inhibitors About Inhibitors Daily Considerations Managing Hemophilia with Inhibitors Surgery in Hemophilia with Inhibitors
Overview
Recognizing a Bleed
Treatment Choices
Immune Tolerance Therapy
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Immune Tolerance Therapy
The only way known to eradicate, or get rid of, inhibitors is through immune tolerance therapy (ITT).
The most common form of ITT uses large doses of the patient’s missing factor VIII or factor IX at different dosing strengths over a period of time to try to desensitize the body’s inhibitor response. If this works, their body will become tolerant of the factor, the inhibitors will disappear, and the patient can go back to being treated with their usual dose of factor VIII or factor IX.10
Since ITT was introduced about 30 years ago, hematologists have been experimenting with different ways of approaching the therapy. These treatment approaches can involve different FVIII or FIX dosing levels; however, the goal is always the same—to get rid of the inhibitor. Based on research, ITT has shown to be effective in 60 to 80% of cases.10
ITT can take from several months to several years to complete. Currently, an international study is underway, which is designed to help determine the most effective and cost-efficient method of administering ITT.10 Previous ITT studies have revealed several indicators that are thought to lead to success11,12
The level of the patient’s titer at the beginning of therapy
How soon therapy is started after diagnosis of inhibitors
A long history of having a low titer
Because ITT uses factor VIII or factor IX more often and in larger amounts than normal, it can be expensive and requires a major commitment from the patient and their family. However, if successful, this may be the best treatment because it can eliminate the inhibitor, allowing the patient to return to their previous factor-replacement therapy.10
During an ITT regimen, it’s often necessary to use a bypassing agent to control bleeding episodes.

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