NovoSeven - Novo Seven - About NovoSeven

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NovoSeven was introduced in the United States in March 1999. It is the only recombinant factor VII product available for the treatment of bleeding episodes and prevention of surgical bleeding in patients with hemophilia A or B with inhibitors to FVIII or FIX and patients with FVII deficiency. FVII is one part of a chain of proteins in the blood that work together to promote clotting.

For people with FVII deficiency or hemophilia and inhibitors to FVIII or FIX, the goal is to resolve bleeding episodes quickly. For a bleed to resolve, a stable clot must be formed at the site of the bleed so that healing can begin. So when the deficient factor in the blood-clotting process can be bypassed or replaced, and the process can continue, the clot formation is closer to being completed.

Under the supervision of a doctor and in the comfort of home, patients can make every minute count when it comes to resolving a bleed quickly.

Here’s how:

			NovoSeven takes only a few minutes to reconstitute

			NovoSeven works at the site of injury^18,19

			NovoSeven is a low-volume treatment (as low as 2.2 mL), so it takes just 2–5 minutes to administer

			NovoSeven can be dosed every 2–3 hours on an as-needed basis

			NovoSeven is available in 1.2-mg, 2.4-mg, and 4.8-mg vials with consistent potency from batch to batch

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.

130601R1 June 2008

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