Selected Important Safety Information for NovoSeven^® RT

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
Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events

NovoSeven^® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for:

Treatment of bleeding episodes and perioperative 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 perioperative management in adults with acquired hemophilia

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

Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance
Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events
Hypersensitivity reactions, including anaphylaxis, can occur with NovoSeven^® RT. Patients with a known hypersensitivity to mouse, hamster, or bovine proteins may be at a higher risk of hypersensitivity reactions. Discontinue infusion and administer appropriate treatment when hypersensitivity reactions occur
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

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

Thrombosis may occur if NovoSeven^® RT is administered concomitantly with Coagulation Factor XIII

Please click here for NovoSeven^® RT Prescribing Information, including Boxed Warning.