Some patients who have received recombinant Factor VIIa (rFVIIa) therapy have experienced thrombotic complications. The risk of a thrombotic event may be higher if certain risk factors are present.


Risk factors for a thrombotic complication:

(1) following cardiac surgery

(2) presence of coronary artery disease

(3) history of hypercoagulable state, venous thromboembolism or arterial thrombosis

(4) presence of disseminated intravascular coagulation (DIC)

(5) during use of extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD)

(6) history of stroke or presence of cerebrovascular disease

(7) history of intestinal ischemia

(8) septicemia

(9) crush injury


The presence of a risk factor for thrombosis is not an absolute contraindication for rFVIIa therapy. However, there should be a clear indication that justifies its use, and the patient should be monitored carefully for signs of a thrombosis.


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