Talking With Your Doctor

Be Prepared

From your first visit as a newly diagnosed patient to your regular comprehensive care visits, you can help your doctor help you by being prepared. Questions are an important way to be sure you get all the information you need.

Here are two sample checklists of questions. The main goal with both checklists is to help you get as much information as possible. The more information you have, the better you can partner with your doctor in making health care decisions.

Newly Diagnosed With Inhibitors—Questions

What type of inhibitor is it?
How severe is it?
Can I eliminate it?
Will there be more bleeds?
Will the bleeds be more serious?
Will the bleeds be more painful?
What treatments are available?
How safe are available treatments?
Can I treat bleeds at home or do I always have to go to an HTC?
Will I have to make changes in my lifestyle and that of my child?
Where can I get more information about daily management of inhibitors?

Considering Surgery—Questions

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 procedure benefit me?
What are the risks of having this procedure?
What will happen if I don't have this procedure?
How common is this procedure?
What is the success rate for people who have hemophilia with inhibitors?

INDICATIONS

NovoSeven^® RT is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital Factor VII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

IMPORTANT SAFETY INFORMATION

The most common side effects in people taking rFVIIa were fever, bleeding, injection site reaction, joint pain, headache, hypertension, hypotension, nausea, vomiting, pain, swelling, and rash.
After taking rFVIIa, 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 are taking NovoSeven^® RT may be at increased risk for thrombosis.
People who have ever had a bad reaction to proteins from mice, hamsters, or "bovines" (such as an ox or cow) should consult their physician prior to using NovoSeven^® RT.
Serious adverse events which may or may not have been related to the use of rFVIIa occurred in 14 of the 298 patients in the initial clinical program.
There have been no reports of rFVIIa causing bad reactions to "analgesics" (such as pain killers), "antibiotics" (the drugs used to treat infection), or "sedatives" (sleeping pills or tranquilizers).
Some patients with Factor VII deficiency have developed resistance (antibodies) to Factor VII after treatment with rFVIIa. These patients had been previously treated with human plasma and/or plasma-derived Factor VII.
Use of NovoSeven^® RT with other formulations of rFVIIa is not recommended due to potential dosing errors resulting from different concentrations.

Please click here for NovoSeven^® RT Prescribing Information

Please click here for original NovoSeven^® Prescribing Information

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. 135550 June 2008