Active Ingredient: Dabigatran
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 150 milligrams dabigatran, 2 times daily.
Dose recommendations for DVT and PE:
| Dose recommendation | |
|---|---|
| Prevention of recurrent DVT, and PE in adults (DVT/PE) | 300 mg dabigatran etexilate taken as one 150 mg capsule twice daily following treatment with a parenteral anticoagulant for at least 5 days |
| Dose reduction recommended | |
| Patients aged ≥80 years | daily dose of 220 mg dabigatran etexilate taken as one 110 mg capsule twice daily |
| Patients who receive concomitant verapamil | |
| Dose reduction for consideration | |
| Patients between 75-80 years | daily dose of dabigatran etexilate of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and the risk of bleeding |
| Patients with moderate renal impairment (CrCL 30-50 mL/min) | |
| Patients with gastritis, esophagitis or gastroesophageal reflux | |
| Other patients at increased risk of bleeding | |
For DVT/PE the recommendation for the use of dabigatran 220 mg taken as one 110 mg capsule twice daily is based on pharmacokinetic and pharmacodynamic analyses and has not been studied in this clinical setting.
In case of intolerability to dabigatran, patients should be instructed to immediately consult their treating physician in order to be switched to alternate acceptable treatment options for DVT/PE. Assessment of renal function prior to and during dabigatran treatment
In all patients and especially in the elderly (>75 years), as renal impairment may be frequent in this age group:
Additional requirements in patients with mild to moderate renal impairment and in patients aged over 75 years:
The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.
Duration of use for DVT/PE:
| Indication | Duration of use |
|---|---|
| DVT/PE | The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding. |
| Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE. |
A forgotten dabigatran dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.
No double dose should be taken to make up for missed individual doses.
dabigatran treatment should not be discontinued without medical advice. Patients should be instructed to contact the treating physician if they develop gastrointestinal symptoms such as dyspepsia.
dabigatran treatment to parenteral anticoagulant:
It is recommended to wait 12 hours after the last dose before switching from dabigatran to a parenteral anticoagulant.
Parenteral anticoagulants to dabigatran:
The parenteral anticoagulant should be discontinued and dabigatran should be started 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)).
dabigatran treatment to Vitamin K antagonists (VKA):
The starting time of the VKA should be adjusted based on CrCL as follows:
Because dabigatran can impact the International Normalized Ratio (INR), the INR will better reflect VKA’s effect only after dabigatran has been stopped for at least 2 days. Until then, INR values should be interpreted with caution.
VKA to dabigatran:
The VKA should be stopped. dabigatran can be given as soon as the INR is <2.0.
It can be taken with or without food.
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