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For Healthcare Professionals

What is Dabigatran Etexilate (Pradaxa®)?

Dabigatran Etexilate (Pradaxa®) is non-vitamin K oral anticoagulation(NOACs) in small product molecule and hydrolysis by esterase-catalysed in plasma and liver to active form. Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma. Since thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus. Dabigatran also inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.

Dabigatran Etexilate (Pradaxa®) is used to:

  • Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation.
  • Prevention of venous thromboembolic events in patients who have undergone orthopaedic surgery for knee or hip replacement.
  • Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death.
  • Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death.

Dabigatran Etexilate (Pradaxa®) is not for use in people with artificial (prosthetic) heart valves replacement. 

IMPORTANT SAFETY INFORMATION AND USE OF Dabigatran Etexilate (Pradaxa®)

For people taking Dabigatran etexilate (Pradaxa®) for atrial fibrillation: Patients should not stop taking Dabigatran etexilate (Pradaxa®) without talking to the doctor who prescribed it. Discontinuation of Dabigatran etexilate (Pradaxa®) without doctor's advice increases risk of having a stroke. Dabigatran etexilate (Pradaxa®) may need to be stopped prior to surgery or a medical or dental procedure. Physician should inform patients on when to stop taking Dabigatran etexilate (Pradaxa®) and when patients may start taking it again. If patients have to stop taking Dabigatran etexilate (Pradaxa®), physician may prescribe another medicine to help prevent a blood clot from forming.

As with all anticoagulants, Dabigatran Etexilate (Pradaxa®) should be used with caution in conditions with an increased risk of bleeding. Bleeding can occur at any site during therapy with Dabigatran Etexilate (Pradaxa®).

Patients on Pradaxa® who undergo surgery or invasive procedures are at increased risk for bleeding. Therefore surgical interventions may require the temporary discontinuation of Pradaxa®.