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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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Treatment Choices
On-demand Therapy
Treatment Methods for Inhibitor Patients
On-demand Therapy Back
When factor is infused into the bloodstream to stop a bleed, it is called on-demand therapy. This is one of the most common methods of treatment in the United States for hemophilia patients who experience bleeding.9
Treatment Methods for Inhibitor Patients Back
On-demand therapy calls for the use of factor replacement on a per-bleed basis. Patients should begin treatment the moment they notice a bleed
For patients with low-responding inhibitors, high doses of the factor VIII (FVIII) or factor IX (FIX) in which they’re deficient may be enough to resolve a bleed3
For patients with high-responding inhibitors, doctors must use other ways to resolve a bleed,3 such as plasmapheresis (time permitting) or bypassing agents (including aPCCs and rFVIIa) as explained in the following table:
Therapies for Treating Bleeding Episodes in Patients with High-responding Inhibitors
*No comparative studies were conducted; therefore, no conclusions regarding the comparative safety or efficacy can be made.

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