Efficacy in Factor VII Deficiency

How NovoSeven^® RT Works With Factor VII Deficiency

For blood to clot, each of the 13 clotting factors must be present and must activate at the right time. People with Factor VII deficiency do not have enough Factor VII so clotting may occur slowly or not at all.

NovoSeven^® RT works by replacing the missing Factor VII. In order to make the blood clot effectively, FVII levels must be brought to a functional state—at least 15%—so only those treatments that contain FVII will work.

Efficacy in Bleeding Episodes

In clinical trials, recombinant Factor VIIa was effective in 93% of nonsurgical and surgical bleeding situations in FVII deficiency.

Efficacy appears to be independent of the location of bleeding
Recombinant Factor VIIa proved effective across a range of serious bleeds

Efficacy in Surgery With FVII Deficiency

In compassionate and emergency-use trials, recombinant Factor VIIa promoted complete hemostasis in 25 out of 25 surgical procedures in which efficacy was recorded.

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