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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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Recommended Surgery
When a doctor recommends surgery for someone who has FVII deficiency, chances are other treatment approaches no longer provide relief from the pain or discomfort from the condition. Or, the surgery may be needed to place a central venous access device or port to help manage the FVII deficiency.
Surgical candidates should start by asking themselves the following questions:
What is my condition?
How is my condition affecting my life?
Am I in severe pain or discomfort?
Is my condition affecting how I want to live?
What will my life be like if I don’t have surgery?
Are the potential benefits of the procedure worth the potential risks?
It's important to understand as much about the procedure as possible. Patients should seek out information about the procedure. Here is a list of questions to ask a hematologist and the surgeon to gain a better understanding of the procedure:
What surgical procedure are you recommending?
Why do I need the procedure?
Are there other ways to treat this condition without having this procedure?
How will this operation benefit me?
What are the risks of having this procedure?
What will happen if I don’t have this procedure?
How common is this surgery?
Is the surgeon experienced in operating on people with rare bleeding disorders?
Will there be a hematologist involved?
How will bleeding be controlled?
Where will I have the operation?
Will I be given anesthesia?
It’s also important for the surgery candidate to know what to expect after the surgery so they can mentally prepare for the recovery process. Here is a list of questions to ask the hematologist, surgeon, and physical therapist to gain a better understanding of postsurgery recovery, including physical therapy:
How long will it take to recover from the anasthesia?
How long will it take to rehabilitate and return to normal activities?
How often will physical therapy be scheduled?
How long will I be in the hospital?
What is the goal of physical therapy?
What kind of range of motion can I expect to regain?

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