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Drug Reference

dabigatran

Direct oral anticoagulant· Brands: PradaxaPO

Mechanism of action
Dabigatran is a direct and reversible thrombin inhibitor. It binds to the active site of thrombin (factor IIa), preventing the conversion of fibrinogen to fibrin and the activation of factors V, VIII, and XI. This inhibits both free thrombin and fibrin-bound thrombin, and also reduces thrombin-induced platelet aggregation.
Pharmacokinetics
Dabigatran etexilate is a prodrug that is metabolised by esterases to the active dabigatran. Oral bioavailability is approximately 6–7%, with peak plasma concentrations occurring 1–2 hours after ingestion. It is about 35% plasma protein bound. Dabigatran is not metabolised by the CYP450 system; it is primarily excreted unchanged in urine, with approximately 80% of a dose recovered renally. The terminal half-life is 12–17 hours, prolonged in renal impairment. It is a substrate of P-glycoprotein; concurrent use of P-gp inhibitors (e.g., clarithromycin) can increase plasma levels, while inducers (e.g., rifampicin) can reduce them. Food delays absorption but does not significantly affect overall exposure.
Indications & dosing

Prevention of stroke and systemic embolism in non-valvular atrial fibrillation (standard dose)

For most patients. Reduce to 110 mg twice daily if age ≥80 years, high bleeding risk, or moderate renal impairment (CrCl 30-50 mL/min).

  • adult · PO: 150 mg twice daily · For most patients. Reduce to 110 mg twice daily if age ≥80 years, high bleeding risk, or moderate renal impairment (CrCl 30-50 mL/min).

Prevention of stroke and systemic embolism in non-valvular atrial fibrillation (reduced dose)

For patients aged ≥80 years, high bleeding risk, or moderate renal impairment (CrCl 30-50 mL/min).

  • adult · PO: 110 mg twice daily · For patients aged ≥80 years, high bleeding risk, or moderate renal impairment (CrCl 30-50 mL/min).

Treatment of acute DVT and PE, and prevention of recurrent VTE

After at least 5 days of initial parenteral anticoagulation. Continue for 6 months or longer as clinically indicated.

  • adult · PO: 150 mg twice daily · After at least 5 days of initial parenteral anticoagulation. Continue for 6 months or longer as clinically indicated.

Prophylaxis of VTE after total hip replacement surgery

Give first dose 110 mg 1-4 hours after surgery, then 220 mg once daily. Reduce to 150 mg once daily for moderate renal impairment (CrCl 30-50 mL/min) or age >80 years.

  • adult · PO: 220 mg once daily · Give first dose 110 mg 1-4 hours after surgery, then 220 mg once daily. Reduce to 150 mg once daily for moderate renal impairment (CrCl 30-50 mL/min) or age >80 years.

Prophylaxis of VTE after total knee replacement surgery

Same as for hip replacement. First dose 110 mg 1-4 hours after surgery, then 220 mg once daily.

  • adult · PO: 220 mg once daily · Same as for hip replacement. First dose 110 mg 1-4 hours after surgery, then 220 mg once daily.
Contraindications & precautions
  • Active clinically significant bleeding · e.g., major GI bleeding, intracranial haemorrhage
  • Hypersensitivity to dabigatran or any excipient
  • Severe renal impairment (CrCl <30 mL/min) · Dose adjustment is not possible; avoid in this population.
  • Mechanical prosthetic heart valve · Increased risk of thromboembolism with dabigatran compared with warfarin.
  • Hepatic impairment with coagulopathy · Use with caution; consider alternatives if significant hepatic disease.
  • Concomitant use of strong P-glycoprotein inhibitors (e.g., ketoconazole, dronedarone) · May increase dabigatran exposure; avoid or use with caution.
  • Monitor renal function before and during treatment, especially in the elderly and in those with renal impairment; assess at least annually.
  • Avoid coadministration with strong P-glycoprotein inducers (e.g., rifampicin) and strong P-glycoprotein inhibitors unless there is no alternative.
  • Consider stopping dabigatran before surgical or invasive procedures; the interval depends on renal function and bleeding risk, and guidance from the local formulary.
  • Use caution in conditions with increased bleeding risk, such as thrombocytopenia, recent surgery, or concurrent antithrombotic therapy.
  • Do not switch from dabigatran to warfarin without adequate anticoagulant overlap; serious bleeding can be reversed with idarucizumab.
Adverse effects
  • Bleeding (e.g., bruising, epistaxis, GI bleeding)serious
  • Dyspepsia
  • Nausea
  • Intracranial haemorrhageserious
  • Anaemia
  • Diarrhoea
Interactions
  • amiodaronemajorIf coadministration is necessary, reduce the dabigatran dose to 150 mg daily for patients with creatinine clearance 30-50 mL/min. For other patients, consider dose reduction or increased monitoring for bleeding. Avoid in severe renal impairment. Alternative anticoagulants should be considered.
  • clopidogrelmajorAvoid co-prescription unless the benefit clearly outweighs the risk, such as in specific cardiac indications. If combined, use the lowest effective doses, monitor closely for signs of bleeding, and consider gastroprotective therapy. Perform regular full blood counts and renal function tests.
  • verapamilmajorAvoid the combination unless clearly necessary. If co-prescribed, reduce dabigatran dose to the lower approved regimen (e.g., 110 mg twice daily) when indicated, and monitor closely for bleeding signs and symptoms. Check renal function before and during therapy. Consider an alternative anticoagulant with a more predictable profile, e.g., apixaban or edoxaban, or an alternative antiarrhythmic agent.
  • aspirinmajorPrescribers should carefully assess the indication for combined therapy, weighing the reduction in thrombotic events against the increased bleeding risk. When the combination is considered necessary, use the lowest effective doses and monitor for signs of bleeding (e.g., haemoglobin, symptoms). Consider gastroprotection with a proton pump inhibitor, particularly in high-risk patients. Avoid concurrent use of additional antithrombotics unless there is a clear indication. Re-evaluate the need for continued combination therapy regularly.
  • naproxenmajorAvoid concomitant use where possible. If anti-inflammatory therapy is needed, prefer an alternative such as paracetamol. When co-administration is unavoidable, use the lowest effective dose of naproxen for the shortest duration, consider gastroprotective therapy (e.g., a proton pump inhibitor), and monitor the patient closely for signs of bleeding, including haemoglobin levels and renal function. Dabigatran dose reduction may be required in renal impairment.
  • clarithromycinmajorAvoid co-prescription. If combination is essential, consider reducing the dabigatran dose and monitor closely for signs of bleeding; alternatively, choose an antibiotic that does not inhibit P-gp (e.g., azithromycin or doxycycline). Consult local guidelines for dabigatran dose adjustment in renal impairment.
  • ibuprofenmajorAvoid concomitant use where possible. If short-term analgesia is required, consider alternatives such as paracetamol or a non-NSAID analgesic. If ibuprofen is essential, use the lowest effective dose for the shortest duration, closely monitor for signs of bleeding, and regularly assess renal function.
  • warfarinmajorAvoid co-prescription. When switching from warfarin to dabigatran, stop warfarin and wait until the International Normalised Ratio (INR) is below 2.0 before starting dabigatran (for most indications). When switching from dabigatran to warfarin, start warfarin while continuing dabigatran for 2–3 days, then stop dabigatran and adjust warfarin dose based on INR. However, this is not routine practice and should follow local guidance.
  • apixabancontraindicatedDo not co-prescribe apixaban and dabigatran. When switching therapy from one to the other, follow established switching guidelines: stop the first anticoagulant and start the second at the time of the next scheduled dose, taking renal function into account. Alternatives should be considered if temporary anticoagulation is needed for procedures or events.
  • omeprazolemoderateUse with caution. Monitor patients for signs and symptoms of bleeding. Consider an alternative proton pump inhibitor with less P-gp inhibition (e.g., pantoprazole) if feasible. If coadministration is necessary, no routine dose adjustment is recommended, but periodic clinical assessment and renal function monitoring are advised.
  • diltiazemmoderateIf co-administration is needed, monitor for signs of bleeding and consider reducing the dabigatran dose (e.g., 110 mg twice daily) or switching to an alternative anticoagulant. Pay particular attention to patients with CrCl <50 mL/min. Avoid this combination in severe renal impairment (CrCl <30 mL/min) or high bleeding risk.
Renal & hepatic adjustment
  • eGFR 0–15: Avoid use in severe renal impairment (CrCl <15 mL/min) or on dialysis. (avoid)
  • eGFR 15–30: Avoid use; dabigatran is contraindicated when CrCl is below 30 mL/min, and no approved reduced dose regimen exists for this level of renal impairment. (avoid)
  • eGFR 30+: Usual dose 150 mg twice daily (or 110 mg twice daily for age ≥80 or high bleeding risk).
  • Hepatic impairment (mild): No dose adjustment required.
  • Hepatic impairment (moderate): No dose adjustment required.
  • Hepatic impairment (severe): Avoid in severe hepatic impairment (Child-Pugh B or C) or hepatic coagulopathy. (avoid)
Monitoring, pregnancy & toxicity
  • Renal function (serum creatinine and eGFR) · Before treatment, then at least annually; more frequently if elderly, at risk of renal impairment, or intercurrent illness.
  • Signs of bleeding (e.g., bruising, epistaxis, melaena) · At each clinical review and if symptoms arise.
  • Haemoglobin and haematocrit · If bleeding suspected, or periodically in high-risk groups.
  • Pregnancy: Dabigatran is contraindicated during pregnancy. It has been associated with fetal harm in animal studies. Advise effective contraception and switch to an alternative anticoagulant (e.g., low molecular weight heparin) before conception or as soon as pregnancy is confirmed.
  • Toxicity: Overdose may cause serious bleeding, including intracranial haemorrhage, gastrointestinal bleeding, and other haemorrhagic complications. · Idarucizumab (5 g IV) is the specific reversal agent for dabigatran. For recent ingestion, consider activated charcoal. Supportive care includes blood products and fluid replacement. Haemodialysis can remove dabigatran; consider if idarucizumab is unavailable.
Antidotes & reversal
  • Idarucizumab · Specific monoclonal Fab fragment (5 g IV); activated charcoal within 2 h of ingestion; dialysis if unavailable.
Clinical notes
Dabigatran is indicated for stroke prevention in non-valvular atrial fibrillation, treatment of venous thromboembolism, and prevention of VTE after hip or knee replacement. For AF, the usual dose is 150 mg twice daily; a 110 mg twice daily regimen is used in patients over 80 years, those with high bleeding risk, or those on verapamil. For VTE treatment, dabigatran is given as 150 mg twice daily after at least 5 days of parenteral anticoagulation. For VTE prophylaxis after hip or knee replacement, the dose is 220 mg once daily, starting 1–4 hours after surgery, with a reduced 150 mg once daily option for high bleeding risk; the duration is 28–35 days after hip and 10–14 days after knee replacement. Renal function must be assessed before use; the drug is contraindicated if creatinine clearance is below 30 mL/min. It is also contraindicated in active bleeding and in patients with mechanical heart valves. Dyspepsia is a common adverse effect. No routine anticoagulation monitoring is required, but renal function should be checked periodically. Idarucizumab is available for reversal. Prescribers should consult local guidelines and formularies.

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BNF; local formulary; manufacturer's prescribing information