Indications and Usage
NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for:
• Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B
with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to
platelet transfusions, with or without antibodies to platelets
• Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia
Important Safety Information
WARNING: THROMBOSIS
• Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported.
• Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients
who will receive NovoSeven® RT.
• Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.
Warnings and Precautions
• Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance.
• Exercise caution when administering NovoSeven® RT to patients with an increased risk of thromboembolic
complications, such as those with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease,
crush injury, septicemia, uncontrolled post-partum hemorrhage, history of coronary heart disease, liver disease,
post-operative immobilization, in elderly patients, in neonates, or in patients receiving concomitant treatment
with aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates).
• Hypersensitivity reactions, including anaphylaxis, have been reported with NovoSeven® RT. Administer only if
clearly needed in patients with known hypersensitivity to NovoSeven® RT, any of its components, or mouse,
hamster, or bovine proteins. Should symptoms occur, discontinue NovoSeven® RT and administer appropriate
treatment.
• Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity
(FVII:C). If FVII:C fails to reach the expected level, or PT is not corrected, or bleeding is not controlled after
treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should
be performed.
• Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving
hemostasis.
Adverse Reactions
• The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse
reactions following the administration of NovoSeven® RT in clinical trials occurred in 4% of patients with acquired
hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia.
Drug I