How to initiate Dabigatran (Pradaxa) therapy?

From the Guidelines

Dabigatran initiation should be done with careful consideration of the patient's condition and renal function, starting with 150 mg twice daily if creatinine clearance (CrCl) is >30 mL/min, as recommended by the most recent guidelines 1. When initiating dabigatran therapy, it is essential to evaluate the patient's renal function, as it plays a crucial role in determining the appropriate dose.

• For patients with CrCl >30 mL/min, the recommended dose is 150 mg twice daily.
• For patients with CrCl 15-30 mL/min, the dose should be reduced to 75 mg twice daily.
• Elderly patients (>80 years) or those with high bleeding risk may benefit from the lower dose of 110 mg twice daily. Before starting dabigatran, it is recommended to obtain baseline renal function, complete blood count, and liver function tests.
• Unlike warfarin, dabigatran does not require routine INR monitoring.
• When transitioning from warfarin to dabigatran, discontinue warfarin and start dabigatran when the INR is <2.0.
• For patients on parenteral anticoagulants, start dabigatran 0-2 hours before the next scheduled dose of the parenteral drug or at the time of discontinuation for continuously administered parenteral drugs. It is also important to advise patients to take dabigatran with food to reduce gastrointestinal side effects, swallow the capsules whole, and not to crush or chew them as this increases absorption. Dabigatran works by directly inhibiting thrombin, providing rapid anticoagulation within 1-2 hours of administration with a half-life of 12-17 hours, making twice-daily dosing necessary for consistent anticoagulation 1.

From the FDA Drug Label

2.5 Administration Dabigatran etexilate capsules should be swallowed whole. Dabigatran etexilate capsules should be taken with a full glass of water. Breaking, chewing, or emptying the contents of the capsule can result in increased exposure If a dose of dabigatran etexilate capsules is not taken at the scheduled time, the dose should be taken as soon as possible on the same day; the missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose.

To initiate Dabigatran (Pradaxa) therapy, the capsules should be swallowed whole with a full glass of water. If a dose is missed, it should be taken as soon as possible on the same day, but not within 6 hours of the next scheduled dose. The dose should not be doubled to make up for a missed dose 2.

From the Research

Initiating Dabigatran Therapy

To initiate dabigatran (Pradaxa) therapy, the following points should be considered:

• Dabigatran is indicated for patients with atrial fibrillation and a moderate or high risk of thrombosis, without associated valvular abnormalities 3.
• The standard dose of dabigatran is 150 mg twice daily, which has been shown to be more effective in preventing cerebrovascular events and systemic embolization than well-controlled warfarin 4.
• A lower dose of 110 mg twice daily may be considered for patients with a higher risk of bleeding 3, 4.
• Dabigatran does not require monitoring of haemostasis, but renal function must be monitored as renal impairment increases the risk of bleeding 3, 4.
• Combination with other antithrombotic agents should be avoided, and the effects of dabigatran are potentiated by combination with P-glycoprotein inhibitors and drugs that impair renal function 3.

Patient Selection

When selecting patients for dabigatran therapy, the following factors should be considered:

• Patients with a high risk of embolism (e.g., ischemic stroke on other oral anticoagulants, presence of left atrial appendage thrombus) and a low risk of bleeding may be suitable for dabigatran 150 mg twice daily 5.
• Patients with a moderate risk of thrombosis may be considered for aspirin or warfarin therapy 3.
• Patients with renal impairment should be closely monitored for changes in renal function 3, 4.

Dosing Regimen

The dosing regimen for dabigatran is twice daily, which has been shown to minimize daily fluctuations in plasma concentrations and maintain trough concentrations sufficient to prevent thrombi while minimizing the risk of bleeding 6.

• Twice daily dosing has been shown to be more effective than once daily dosing in maintaining adequate minimum trough concentrations, even in patients who miss or delay taking one scheduled dose 6.