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Factor viia, Recombinant

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.

Patient Counseling Information

NOVOSEVEN RT

Package Inserts

NovoSeven RT Coagulation Factor VIIa

Updated October 2016