Direct Oral Anticoagulant — Direct Thrombin Inhibitor Pregnancy: Women of childbearing potential should avoid pregnancy during treatment. Limited data in pregnant women; animal studies have shown reproductive toxicity and the potential risk for humans is unknown. Should not be used during pregnancy unless clearly necessary. Breast-feeding should be discontinued during treatment.

Dabigatran (Orthopaedic VTE Prophylaxis)

Brand names: Pradaxa

Dabigatran etexilate is an oral direct thrombin inhibitor licensed for prevention of venous thromboembolism after elective hip or knee replacement surgery. This page covers its use as orthopaedic VTE prophylaxis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Initiation on the day of surgery: a single capsule of 110 mg, 1–4 hours after completed surgery. Maintenance, starting on the first day after surgery: 220 mg once daily, taken as 2 capsules of 110 mg.

Route: Oral

Frequency: Once daily

Duration of the maintenance dose: 10 days after elective knee replacement surgery; 28–35 days after elective hip replacement surgery. For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed; if treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily. DOSE REDUCTION recommended (initiation: a single capsule of 75 mg; maintenance: 150 mg once daily taken as 2 capsules of 75 mg, same durations) in: patients with moderate renal impairment (CrCl 30–50 mL/min); patients receiving concomitant verapamil, amiodarone or quinidine; and patients aged 75 or above. In patients with moderate renal impairment who are concomitantly treated with verapamil, a dose reduction to 75 mg daily should be considered. Dabigatran and mild-to-moderate P-gp inhibitors should be taken at the same time. Assess renal function (Cockcroft-Gault CrCl) before starting to exclude severe renal impairment, and whenever a decline in renal function is suspected. Missed dose: continue with the remaining daily doses at the same time the next day; do not double the dose. Do not discontinue without medical advice; instruct patients to contact the prescriber if gastrointestinal symptoms such as dyspepsia develop. Switching: wait 24 hours after the last dabigatran dose before starting a parenteral anticoagulant; when switching from a parenteral anticoagulant, start dabigatran 0–2 hours before the next dose of the alternate therapy would be due (or at the time of discontinuation for continuous therapy such as IV unfractionated heparin). Weight: very limited experience below 50 kg or above 110 kg — no adjustment considered necessary but close clinical surveillance is recommended. PAEDIATRIC: the SPC states there is no relevant use of dabigatran etexilate in the paediatric population for primary prevention of VTE after elective total hip or total knee replacement surgery.

Dose adjustments

Renal

Contraindicated if CrCl <30 mL/min. Moderate renal impairment (CrCl 30–50 mL/min): reduced regimen — a single 75 mg capsule 1–4 hours after surgery, then 150 mg once daily (2 × 75 mg capsules), for 10 days (knee) or 28–35 days (hip). If also receiving verapamil, a reduction to 75 mg daily should be considered. Estimate renal function by the Cockcroft-Gault method before starting and whenever a decline is suspected.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Severe renal impairment (CrCl <30 mL/min) in adults; eGFR <50 mL/min/1.73m² in paediatric patients
Active clinically significant bleeding
Lesion or condition considered a significant risk factor for major bleeding (e.g. current or recent GI ulceration, malignant neoplasms at high bleeding risk, recent brain or spinal injury, recent brain/spinal/ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities)
Concomitant treatment with any other anticoagulant (unfractionated heparin, LMWH, heparin derivatives, oral anticoagulants) except in the specific circumstances listed in the SPC (switching therapy, UFH to keep a central venous or arterial catheter open, UFH during catheter ablation for atrial fibrillation)
Hepatic impairment or liver disease expected to have any impact on survival
Concomitant treatment with strong P-gp inhibitors: systemic ketoconazole, ciclosporin, itraconazole, dronedarone, and the fixed-dose combination glecaprevir/pibrentasvir
Prosthetic heart valves requiring anticoagulant treatment

Side effects

Bleeding — the most common event, occurring in approximately 14% of patients treated short-term for elective hip or knee replacement surgery; major or severe bleeding may be disabling, life-threatening or fatal
Haemoglobin decreased (common in the VTE-prevention setting); anaemia (uncommon)
Haematocrit decreased (uncommon); thrombocytopenia (rare)
Drug hypersensitivity (uncommon); rash, pruritus, anaphylactic reaction, angioedema, urticaria (rare)
Gastrointestinal symptoms such as dyspepsia — patients should contact the prescriber if these develop

Interactions

Strong P-gp inhibitors (systemic ketoconazole, ciclosporin, itraconazole, dronedarone, glecaprevir/pibrentasvir) — concomitant use contraindicated (UK SPC §4.3)
Mild to moderate P-gp inhibitors — amiodarone, quinidine, verapamil: reduce the dose as in the SPC dosing table and take at the same time as dabigatran (UK SPC §4.2/§4.5)
Other anticoagulants (UFH, LMWH such as enoxaparin or dalteparin, fondaparinux, warfarin, rivaroxaban, apixaban) — concomitant use contraindicated outside the defined switching/catheter situations (UK SPC §4.3)
P-gp inducers (e.g. rifampicin) — reduce dabigatran exposure; coadministration should generally be avoided (US label §7)
Renal impairment plus a P-gp inhibitor together produce greater exposure than either factor alone (US label §7)

Clinical monograph

How it works

It is a prodrug converted to dabigatran, which directly and reversibly inhibits thrombin (factor IIa), preventing conversion of fibrinogen to fibrin and thrombus formation.

Prescribing in practice

Bleeding is the principal risk — it is contraindicated in active clinically significant bleeding and severe renal impairment, and renal function must be assessed before and during use because clearance is largely renal.
Idarucizumab is a specific reversal agent for emergency bleeding or urgent surgery, and concomitant strong P-glycoprotein inhibitors or other antithrombotics substantially increase bleeding risk.
Capsules must not be removed from the blister or crushed as this raises absorption and bleeding risk, and dosing/frequency follow the surgical prophylaxis schedule in the SPC with the first dose timed after haemostasis.

Monitoring

Routine coagulation monitoring is not required, but check renal function periodically and before procedures and observe for signs of bleeding.

Counselling the patient

Report unusual bruising, bleeding that will not stop, black stools or blood in urine.
Swallow the capsule whole and keep it in its original blister pack until use; do not crush or open it.
Tell any clinician or dentist you take an anticoagulant before procedures.

Evidence & guidelines

Dabigatran for VTE prophylaxis after major orthopaedic surgery is supported by the RE-MODEL and RE-NOVATE trial programme and is included in NICE VTE prevention guidance.

Reference: RE-NOVATE Trial (Lancet 2007); RE-MODEL Trial (J Thromb Haemost 2007); NICE NG89; SPC Pradaxa; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways