Serious Thrombotic Adverse Events Associated with Recombinant Coagulation Factor VIIa Outside Label Indicatons

• Arterial and venous thrombotic and thromboembolic events following administration of Coagulation Factor VIIa Recombinant have been reported.
• Clinical studies have shown increased risk of arterial thromboembolic adverse events with this product when administered outside the current approved indications. Fatal and non-fatal thrombotic events have been reported.
• Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive this product.
• Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. See WARNINGS AND PRECAUTIONS section of prescribing information.
• Safety and efficacy of NovoSeven RT has not been established outside the approved indications.