Dabigatran Etexilate (Pradaxa)

Pharmacology or Pradaxa (dapigatran)

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Pharmacologic profile and clinical uses

Mechanism of action

Direct thrombin inhibitor: Dabigatran directly inhibits thrombin (factor IIa), which is a key enzyme in the coagulation cascade responsible for the conversion of fibrinogen to fibrin, thus preventing clot formation.

Indications

Non-valvular atrial fibrillation: To reduce the risk of stroke and systemic embolism.
Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE): Treatment and reduction of recurrence.
Prophylaxis of DVT and PE: Following hip replacement surgery.

Key aspects of drug therapy management

Dosage and administration

Non-valvular atrial fibrillation: 150 mg orally twice daily.
DVT/PE treatment and reduction of recurrence: 150 mg orally twice daily after 5-10 days of parenteral anticoagulation.
Post-Hip replacement prophylaxis: 110 mg orally on the first day, then 220 mg once daily.
Renal Impairment: Dosage adjustment may be necessary; contraindicated in severe renal impairment (CrCl < 30 mL/min).

Side effects

Bleeding: Increased risk of bleeding, including gastrointestinal and intracranial bleeding.
Gastrointestinal symptoms: Dyspepsia, gastritis-like symptoms.

Drug interactions

P-glycoprotein inhibitors: Such as ketoconazole, which can increase dabigatran levels.
Antiplatelet agents and NSAIDs: May increase bleeding risk.

Reversal agent

Idarucizumab (Praxbind): A monoclonal antibody fragment specifically indicated for reversing the anticoagulant effects of dabigatran in cases of emergency surgery/urgent procedures or life-threatening or uncontrolled bleeding.

Monitoring and considerations

Routine monitoring: Not required, unlike warfarin. However, renal function should be monitored periodically.
Transitioning: Care must be taken when transitioning from or to other anticoagulants to minimize the risk of thrombosis or bleeding.

This note has been edited and reviewed by the pharmacy doctors on NPS team.