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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
Recommended Surgery
Types of Surgery
What to Expect
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Types of Surgery
From simple dental procedures to major heart surgery, surgical procedures have been performed successfully in patients with FVII deficiency.
Surgery can be classified as either elective or emergency.
Elective surgery consists of those procedures that are not considered essential to a person’s survival. Usually, there are other treatment choices available, but the person may choose to have surgery if they see how it could improve their quality of life or if they have had no good responses from other treatments
Emergency surgery is done in response to an urgent medical need, like injuries suffered in an auto accident. It has to be done immediately
These two classes of surgery represent a wide range of procedures. While many surgeons may describe certain surgeries as either minor or major, the reality is that all surgeries and invasive procedures should be considered major for people with FVII deficiency.

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