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FDA Approves NOVO NORDISK's NovoSeven(R) RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors
Date:5/13/2008

lex concentrates (aPCCs), to resolve bleeds. Patients with lower responding inhibitors may be treated with high doses of either Factor VIII or Factor IX to stop bleeding.

About NovoSeven(R) RT and NovoSeven(R)

NovoSeven(R) RT and NovoSeven(R) are 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 FVII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

For prescribing information, please visit NovoSevenRT.com.

Important Safety Information:

NovoSeven(R) 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(R) 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(R). After taking NovoSeven(R), 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 th
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