New Oral Anticoagulants – Pradaxa®(dabigatran)

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What You Need to know About Pradaxa® (dabigatran)

In the prior two editions of this newsletter we discussed Xarelto® and Eliquis®, including indications, dosing guidelines, and administration pearls.  This month, we will discuss Pradaxa® (dabigatran), which has a slightly different mechanism of action.  Pradaxa® is a direct thrombin inhibitor which disrupts the coagulation cascade preventing the development of clots in the blood.  Remember Xarelto and Eliquis are Factor Xa inhibitors.  Pradaxa® is dosed twice daily, has more complex dosing recommendations than other agents, and also needs to be adjusted for renal function.  Pradaxa has all of the advantages of the other new oral anticoagulants compared to that of warfarin and also has a FDA approved reversal agent idarucizumab (reversal agents may be available soon for the other medications in this class).

Pradaxa® (dabigatran) Approved Indications and Dosages:

Non-valvular A.Fib. – Stroke and embolism prevention:  150mg PO twice daily.

DVT or PE Treatment (in patients treated with parental anticoagulant for 5-10 days):  150 mg PO twice daily.

DVT or PE Prevention:  150mg PO BID.

DVT prevention post hip replacement surgery:  110mg PO on the first day 1-4 hours after surgery, then 220mg PO daily for 28-35 days.

DVT prevention post knee replacement surgery:  150 or 220mg PO once daily with a half dose 1-4 hours after surgery.  Guidelines suggest continuing for 10-35 days.


May be taken without regard to food. Capsules should not be opened or crushed.  Capsules need to be stored in the manufacturer’s container and used within four months of opening.   Do not repackage or store capsules in any other container due to potential product break down.

Dose adjustment for elderly:

The Beers Criteria lists Pradaxa® as a potentially inappropriate medication in patients 75 years of age and older.  Caution is recommended given the lack of evidence for efficacy and safety in patients with a creatinine clearance (CrCl) less than 30 mL/min and a greater risk of bleeding than with other oral anticoagulants including warfarin.  According to the manufacturer, the risk-benefit profile is favorable among all age groups.

Dosage adjustments for patients with A.Fib.

CrCl 15 to 30 mL/min: 75 mg PO twice daily.
CrCl less than 15 mL/min: Dosing recommendations not provided
With concomitant use of P-glycoprotein (P-gp) inhibitors*:
CrCl 30 to 50 mL/min: Dose reduction to 75 mg PO twice daily should be considered when coadministered with the P-gp inhibitors dronedarone or ketoconazole.

CrCl less than 30 mL/min: Avoid coadministration.

Dosage adjustments for patients post hip or knee replacement:

CrCl more than 30 mL/min: No dosage adjustment needed.
CrCl 30 mL/min or less: Dosing recommendations not provided
With concomitant use of P-glycoprotein (P-gp) inhibitors*:
CrCl less than 50 mL/min: Avoid coadministration.

*Common P-gp inhibitors include ketoconazole, itraconazole, dronedarone, verapamil, quinidine, amiodarone, clarithromycin, and erythromycin.  Your AlixaRx Pharmacists screen for drug interactions prior to dispensing all medications.


Challenge yourself to know the names and dosages of these new oral anticoagulants.  Ensure an accurate indication (diagnosis) is entered into your electronic health record.  Utilize drug information resources to double check that the dose and duration are appropriate.  Ask your AlixaRx Clinical Pharmacist for additional guidance on the use of these agents.

Don’t miss a review of Savaysa® (edoxaban) in the next addition of From the Front Lines.


References: Clinical Pharmacology accessed 6/28/16.  Available at:

This article was originally published in our monthly issue of From the Front Lines – a monthly publication that shares best practices and medication-related challenges faced by “front line” staff in long-term care and post-acute (LTCPAC) facilities.

>>> From the Front Lines – August 2016 <<<