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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
What Are Inhibitors?
Who Gets Inhibitors?
Diagnosing an Inhibitor
Talking With a Doctor
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Diagnosing an Inhibitor
Your doctor might suspect an inhibitor if standard factor replacement therapy stops working.
You may have an inhibitor if3 :
A higher dose of factor than usual is needed to stop the bleeding
Treatment takes longer than usual to work
More than the usual number of treatments are needed to stop the bleeding
Inhibitors can also be detected during routine testing for inhibitors, which is usually done during yearly comprehensive care visits at a hemophilia treatment center (HTC) and before surgery.3
Testing for, Measuring, and Classifying Inhibitors
Inhibitors are confirmed through a blood test called a Bethesda inhibitor assay. This test measures the level of antibody (inhibitor) activity that occurs when a person’s blood is exposed to a specific amount of a certain clotting factor.
Titer
The concentration or amount of antibodies determines the level of the inhibitor. This level is reported as Bethesda titer, which is measured in Bethesda units (BUs). The more antibodies that are present in the blood sample, the higher the Bethesda titer.5 Over time, a patient’s inhibitor level can change, going from low to high or high to low.
Inhibitor types
Inhibitors are classified by the way they respond to factor treatment. They are either low-responding or high-responding. However, the type of inhibitor a person has can change over time—they can even be transient, which means that they can appear after the start of factor replacement and then disappear spontaneously (on their own).
Low-responding inhibitors have a slow and weak response to the factor. Low-responding inhibitors are low-titer inhibitors (they have a Bethesda titer of less than 5 BUs). Low-titer inhibitors make replacement therapy difficult, but bleeding can usually be stopped by increasing the dose of factor VIII or factor IX 3
High-responding inhibitors react to therapy quickly—that is, the antibodies rise to high levels when exposed to the factor. The Bethesda titer is at 5 BUs or higher. Because of the high immune response, it is likely that replacement with the missing factor will not work.3 Alternative treatments must be investigated, such as plasmapheresis or the use of bypassing products.

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