Formulary
Dabigatran etexilate: Indications, Dosing, Side Effects and Interactions
Dabigatran etexilate is a direct thrombin inhibitor with a rapid onset of action.
MedNext Academy | 8 min read
Dabigatran etexilate: Indications, Dosing, Side Effects and Interactions
Dabigatran etexilate is a direct thrombin inhibitor with a rapid onset of action.
Drug action
Dabigatran etexilate is a direct thrombin inhibitor with a rapid onset of action.
Indications and dose
**Prophylaxis of venous thromboembolism following total knee replacement surgery**
- **Adult** (By Mouth): 75 years and over 75 mg for 1 dose, to be taken 1-4 hours after surgery, followed by 150 mg once daily for 10 days, to be taken on the first day after surgery.
**Prophylaxis of venous thromboembolism following total knee replacement surgery in patients receiving concomitant treatment with amiodarone or verapamil**
- **Adult** (By Mouth): 75 years and over 75 mg for 1 dose, to be taken 1-4 hours after surgery, followed by 150 mg once daily for 10 days, to be taken on the first day after surgery.
**Prophylaxis of venous thromboembolism following total hip replacement surgery**
- **Adult** (By Mouth): 75 years and over 75 mg for 1 dose, to be taken 1-4 hours after surgery, followed by 150 mg once daily for 28-35 days, to be taken on the first day after surgery.
**Prophylaxis of venous thromboembolism following total hip replacement surgery in patients receiving concomitant treatment with amiodarone or verapamil**
- **Adult** (By Mouth): 75 years and over 75 mg for 1 dose, to be taken 1-4 hours after surgery, followed by 150 mg once daily for 28-35 days, to be taken on the first day after surgery.
**Treatment of deep-vein thrombosis,Treatment of pulmonary embolism,Prophylaxis of recurrent deep-vein thrombosis,Prophylaxis of recurrent pulmonary embolism**
- **Adult** (By Mouth): 80 years and over 110 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
**Treatment of deep-vein thrombosis in patients with moderate renal impairment,Treatment of deep-vein thrombosis in patients at increased risk of bleeding,Treatment of pulmonary embolism in patients with moderate renal impairment,Treatment of pulmonary embolism in patients at increased risk of bleeding,Prophylaxis of recurrent deep-vein thrombosis in patients with moderate renal impairment,Prophylaxis of recurrent deep-vein thrombosis in patients at increased risk of bleeding,Prophylaxis of recurrent pulmonary embolism in patients with moderate renal impairment,Prophylaxis of recurrent pulmonary embolism in patients at increased risk of bleeding**
- **Adult** (By Mouth): 110-150 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
**Treatment of deep-vein thrombosis in patients receiving concomitant treatment with verapamil,Treatment of pulmonary embolism in patients receiving concomitant treatment with verapamil,Prophylaxis of recurrent deep-vein thrombosis in patients receiving concomitant treatment with verapamil,Prophylaxis of recurrent pulmonary embolism in patients receiving concomitant treatment with verapamil**
- **Adult** (By Mouth): 110 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
**Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation and with one or more risk factors such as previous stroke or transient ischaemic attack, symptomatic heart failure, age 75 years, diabetes mellitus, or hypertension**
- **Adult** (By Mouth): 80 years and over 110 mg twice daily.
**Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation and with one or more risk factors such as previous stroke or transient ischaemic attack, symptomatic heart failure, age 75 years, diabetes mellitus, or hypertension in patients receiving concomitant treatment with verapamil**
- **Adult** (By Mouth): 110 mg twice daily.
**Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation and with one or more risk factors such as previous stroke or transient ischaemic attack, symptomatic heart failure, age 75 years, diabetes mellitus, or hypertension, in patients at increased risk of bleeding,Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation and with one or more risk factors such as previous stroke or transient ischaemic attack, symptomatic heart failure, age 75 years, diabetes mellitus, or hypertension, in patients with moderate renal impairment**
- **Adult** (By Mouth): 110-150 mg twice daily.
**Treatment of venous thromboembolism, Prophylaxis of recurrent venous thromboembolism for dabigatran etexilate**
- **Child 4-11 months (body-weight 2.5 kg and above)** (By mouth using granules): Doses are based on body-weight and age in months-consult product literature, to be given following at least 5 days treatment with a parenteral anticoagulant.
- **Child 1-11 years (body-weight 5 kg and above)** (By mouth using granules): Doses are based on body-weight and age in years-consult product literature, to be given following at least 5 days treatment with a parenteral anticoagulant.
- **Child 8 years (body-weight 11-12 kg)** (By mouth using capsules): 75 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
- **Child 8-13 years (body-weight 13-20 kg)** (By mouth using capsules): 110 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
- **Child 8-17 years (body-weight 21-30 kg)** (By mouth using capsules): 150 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
- **Child 8-17 years (body-weight 31-40 kg)** (By mouth using capsules): 185 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
- **Child 8-17 years (body-weight 41-50 kg)** (By mouth using capsules): 220 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
- **Child 8-17 years (body-weight 51-60 kg)** (By mouth using capsules): 260 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
- **Child 8-17 years (body-weight 61 kg and above)** (By mouth using capsules): 300 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
Cautions
Anaesthesia with postoperative indwelling epidural catheter (risk of paralysis-give initial dose at least 2 hours after catheter removal and monitor neurological signs); bacterial endocarditis; bleeding disorders; body-weight less than 50 kg; elderly; gastritis; gastro-oesophageal reflux; oesophagitis; recent biopsy; recent major trauma; risk of bleeding; thrombocytopenia Cautions, further information Elderly For direct thrombin inhibitors, Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: with concurrent significant bleeding risk, such as uncontrolled severe hypertension, bleeding diathesis or recent non-trivial spontaneous bleeding (high risk of bleeding) for first deep venous thrombosis without continuing provoking risk factors (e.g. thrombophilia) for greater than 6 months (no proven added benefit) for first pulmonary embolus without continuing provoking risk factors for greater than 12 months (no proven added benefit) as part of dual therapy with an antiplatelet agent in patients with stable coronary, cerebrovascular or peripheral arterial disease, without a clear indication for anticoagulant therapy (no added benefit) if eGFR less than 30 mL/min/1.73 m (contra-indicated in severe renal impairment; risk of bleeding)
Contraindications
Active bleeding; antiphospholipid syndrome (increased risk of recurrent thrombotic events); arteriovenous malformation; do not use as anticoagulant for prosthetic heart valve; major intraspinal or intracerebral vascular abnormalities; malignant neoplasms at high risk of bleeding; oesophageal varices; recent brain or spinal injury; recent brain surgery; recent gastro-intestinal ulcer; recent intracranial haemorrhage; recent ophthalmic surgery; recent spine surgery; significant risk of major bleeding; use with any other anticoagulant; vascular aneurysm Contra-indications, further information Use with any other anticoagulant Concomitant use with any other anticoagulant is contra-indicated, except when switching therapy, or when heparin is given at doses necessary to maintain an open central venous or arterial catheter or for catheter ablation-use with caution. M
Side effects
Common or very common Anaemia; diarrhoea; gastrointestinal discomfort; haemorrhage; hepatic function abnormal; nausea Uncommon Dysphagia; gastrointestinal disorders; hyperbilirubinaemia; intracranial haemorrhage; post procedural complications; skin reactions; thrombocytopenia; vomiting; wound complications Rare or very rare Angioedema; post procedural drainage; wound drainage Frequency not known Agranulocytosis; alopecia; bronchospasm; neutropenia
Interactions
**Other interactions (35):**
- Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0- and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple...
- Itraconazole, cyclosporine Based on in vitro results a similar effect as with ketoconazole may be expected.
- Concomitant use not recommended Tacrolimus Tacrolimus has been found in vitro to have a similar level of inhibitory effect on P-gp as that seen with itraconazole and cyclosporine.
- Dabigatran etexilate has not been clinically studied together with tacrolimus.
- However, limited clinical data with another P-gp substrate (everolimus) suggest that the inhibition of P-gp with tacrolimus is weaker than that observed with strong P-gp inhibitors.
- Cautions to be exercised in case concomitant use (see sections 4.2 and 4.4) Verapamil When dabigatran etexilate (150 mg) was co-administered with oral verapamil, the Cmax and AUC of dabigatran were...
Pregnancy
Manufacturer advises avoid unless essential-toxicity in animal studies.
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
Manufacturer advises avoid in severe impairment; consider avoiding in those with liver enzymes greater than 2 times the upper limit of normal (no information available).
Renal impairment
Treatment of deep-vein thrombosis in patients with moderate renal impairment, Treatment of deep-vein thrombosis in patients at increased risk of bleeding, Treatment of pulmonary embolism in patients with moderate renal impairment, Treatment of pulmonary embolism in patients at increased risk of bleeding, Prophylaxis of recurrent deep-vein thrombosis in patients with moderate renal impairment, Prophylaxis of recurrent deep-vein thrombosis in patients at increased risk of bleeding, Prophylaxis of recurrent pulmonary embolism in patients with moderate renal impairment, Prophylaxis of recurrent pulmonary embolism in patients at increased risk of bleeding for dabigatran etexilate By mouth Adult 110-150 mg twice daily, to be given following at least 5 days treatment with a parenteral anticoagulant.
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Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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