Once a bottle of dabigatran is opened, the medication is considered to be expired after only thirty days. An antidote is available
- New drug to prevent stroke/systemic embolism in non valvular AF with additional risk factor
- An expensive alternative to Warfarin - approximately £3 per day
- No need to monitor INR which may increase acceptance of anticoagulation therapy for some
- Direct thrombin inhibitor
- Clots all depend on the formation of fibrin
- Inhibits the thrombin enzyme preventing the conversion of fibrinogen to fibrin
- Half life 12-17 hrs, 80% renal excreted, antidote available (Praxbind)
Indication and Dose
- Patients had one non-AF stroke risk factor, which could include
- Prior stroke or TIA, LVEF < 40%
- NYHA class 2 to 4 heart failure within the prior six months
- Age >75 or age 65 to 74 with diabetes
- Hypertension, Coronary disease.
- Dabigatran 150 mg bd is superior to Warfarin at reducing the risk of stroke or systemic embolism
- Dabigatran 110 mg bd was non-inferior to Warfarin for reducing the incidence of stroke or systemic embolism
Non valvular AF
- With one of the following previous stroke or TIA, CCF, age > 75 years, diabetes mellitus or hypertension
- Adult 18 to 74 years Dabigatran 150 mg BD.
- Adult 75 to 79 years Dabigatran 110 to 150 mg BD.
- Adult 80 years and over Dabigatran 110 mg BD.
- Adult 18 to 74 years Dabigatran 150 mg BD, following 5+ treatment with a parenteral anticoagulant.
- Adult 75 to 79 years Dabigatran 110 to 150 mg BD following at least 5 days treatment with a parenteral anticoagulant.
- Adult 80 years and over Dabigatran 110 mg BD, following at least 5 days treatment with a parenteral anticoagulant.
- Verapamil - use lower dose Dabigatran 110 mg bd
- Other Anticoagulants and antithrombotic drugs or coagulopathy
- High HAS-BLED score, Poorly controlled BP, Renal failure
- Bleeding with Dabigatran is harder to stop than with Warfarin as there is no specific antidote
- Renal failure, Active pathological bleeding, Severe hypersensitivity reaction
- Significant risk of major bleeding: GI ulcer, oesophageal varices
- Recent brain, spine, or ophthalmic surgery
- Recent intracranial haemorrhage, malignant neoplasms, vascular aneurysm
- Overall bleeding risk the same for Warfarin and Dabigatran 150 mg bd
- Reduced bleeding compared with Warfarin for Dabigatran 110 mg bd
- Dabigatran significantly lower risk of haemorrhagic stroke compared with Warfarin
- Dabigatran 150 mg twice daily had a significantly higher incidence of major gastrointestinal bleeding
- Dyspepsia and GI symptoms
- Do not break, chew or crush capsules
- Keep capsules in an original container do not store or place in other containers
- After opening the original container, capsules expire in 120 days
Haemorrhage - intracranial or extracranial
- In haemorrhage find out when the last dose is taken as half-life 15 hours.
- Apply pressure to wound or other physical effects. Manage as for haemorrhage.
- Renal Dialysis is suggested to remove the drug.
- Discuss other options e.g. FFP and prothrombin concentrate with the haematologist.
- Currently there is no actual antidote and this is likely to be an increasing future problem.