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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
Recommended Surgery
Types of Surgery
What to Expect
Preparing for Surgery
Post-surgery Care
Surgery FAQs
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What to Expect
Before Surgery
During Surgery
After Surgery
Before Surgery Back
Meeting With Doctors
Any surgical candidate with hemophilia with inhibitors should plan to meet with their hematologist and HTC treatment team before the surgery
The hematologist will lead the planning for the surgery. As part of this planning, the hematologist will likely ask the candidate to talk with one or more surgeons, which is a great chance for the candidate to learn as much as possible about the surgery
The surgeon will need to work with the candidate and the hematologist during the weeks and days leading up to surgery and also after the procedure. A caregiver should be involved since they will play an integral role in the patient's preparation, recovery, and rehabilitation
Assessments
The HTC team and the surgeon may conduct the following assessments prior to surgery:
Blood tests may include a Bethesda assay to monitor a patient’s inhibitor levels
The doctor will want to determine the likelihood of an anamnestic response
and potential for thrombosis
Instructions
The surgeon will give instructions on what to do in the days before the operation and the morning of the procedure. These instructions will likely include guides on nutrition, activity, and medications
The hematologist, nurse, physical therapist, and social worker may also provide instructions prior to surgery to ensure a smooth procedure and recovery
During Surgery Back
The surgeon and the hematologist will have a plan in place for managing bleeding during surgery. The surgeon will have worked closely with the entire surgical team, especially the anesthesiologist, to ensure everything goes as planned.
After Surgery Back
Immediately after the surgery, the patient will be moved to a recovery area where a nurse and the anesthesiologist will monitor blood pressure, breathing, and other vital signs. As the anesthesia wears off, the surgical team will manage the patient's care, which includes the use of pain medications.
During this time, the surgeon will talk to the family or caregiver to let them know the patient's status.
After the patient has been cleared from postoperative recovery, they will be transported to their room in the hospital. There, the patient’s recovery will be monitored by nurses and nurse assistants, who will help keep the patient as comfortable as possible. The surgeon will receive updates on the patient’s recovery and check in on the patient to evaluate how the surgical site is healing.
The staff will seek to get the patient active as quickly as possible to promote healing and avoid post-surgical complications.

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