• glossary
• professional site
• prescribing information

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

• 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 consult their physician prior to using NovoSeven^® RT.
• 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 are 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.
• 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 tranquilizers).
• Some patients with Factor VII deficiency have developed resistance (antibodies) to Factor VII after treatment with NovoSeven^®. These patients had been previously treated with human plasma and/or plasma-derived Factor VII.
• Use of NovoSeven^® RT with other formulations of NovoSeven^® is not recommended due to potential dosing errors resulting from different concentrations.
• The long-term use of NovoSeven^® RT after bleeding has stopped has not been extensively studied in a clinical setting.

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

• disclaimer & privacy
• site map
• references
• contact novo nordisk