What is the dosing for Pradaxa (dabigatran) for provoked pulmonary embolism (PE)?

From the Guidelines

For provoked pulmonary embolism (PE), Pradaxa (dabigatran) is typically dosed at 150 mg taken orally twice daily after 5-10 days of initial parenteral anticoagulation therapy (such as heparin or low molecular weight heparin). This dosing recommendation is based on the most recent and highest quality study available, which is the 2020 American Society of Hematology guidelines for management of venous thromboembolism 1. For elderly patients (over 80 years), those with moderate renal impairment (CrCl 30-50 mL/min), or patients taking P-glycoprotein inhibitors, the dose should be reduced to 110 mg twice daily, as indicated in the 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism 1.

Key Considerations

• Treatment duration for provoked PE is generally 3-6 months, with the exact duration depending on the nature of the provoking factor and the patient's risk of recurrence versus bleeding 1.
• Pradaxa should be taken with a full glass of water, with or without food, at approximately the same times each day.
• Patients should not stop taking Pradaxa without consulting their healthcare provider due to increased risk of stroke or blood clots.
• Pradaxa works as a direct thrombin inhibitor, preventing the formation of blood clots by blocking the activity of thrombin, a key enzyme in clot formation.
• Regular monitoring of renal function is important as the medication is primarily eliminated by the kidneys.

Important Notes

• The 2020 American Society of Hematology guidelines suggest that the standard dose of dabigatran (150 mg twice daily) may be used for secondary prevention of VTE, but additional research is necessary to identify which subsets of patients can safely use a lower-dose DOAC 1.
• The 2014 ESC guidelines recommend that anticoagulation should cover at least 3 months, and extended anticoagulation beyond the first 3 months, or even indefinitely, may be necessary for secondary prevention, after weighing the individual patient’s risk of recurrence vs. bleeding risk 1.

From the FDA Drug Label

For patients with CrCl >30 mL/min, the recommended dose of dabigatran etexilate capsules is 150 mg taken orally, twice daily, after 5 to 10 days of parenteral anticoagulation Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients For patients with CrCl >30 mL/min, the recommended dose of dabigatran etexilate capsules is 150 mg taken orally, twice daily, after 5 to 10 days of parenteral anticoagulation

The recommended dose of Pradaxa (dabigatran etexilate) for treatment of provoked pulmonary embolism (PE) in adult patients with CrCl >30 mL/min is 150 mg orally, twice daily, after 5 to 10 days of parenteral anticoagulation 2.

• Key considerations:
  • Renal function: Assess renal function prior to initiation of treatment with dabigatran etexilate capsules.
  • Dosing adjustments: Dosing recommendations for patients with CrCl ≤30 mL/min or on dialysis cannot be provided.
  • Concomitant use of P-gp inhibitors: Avoid use of concomitant P-gp inhibitors in patients with CrCl <50 mL/min.
• Administration: Dabigatran etexilate capsules should be swallowed whole with a full glass of water.

From the Research

Pradaxa Dosing for Provoked PE

• The dosing for Pradaxa (dabigatran) in patients with provoked pulmonary embolism (PE) is 150 mg twice a day for 6 months, as shown in the RE-SPIRE trial 3.
• This dosing regimen has been compared to warfarin, with results indicating that dabigatran is comparable in effectiveness to warfarin, but has greater safety in terms of bleeding complications 3.
• The use of direct oral anticoagulants (DOACs) like dabigatran has simplified the initial treatment of PE, and they are becoming the agents of first choice due to their practicability 4.
• However, low molecular weight heparins (LMWHs) will continue to play an important role in initial PE treatment, especially in cases where DOACs are contraindicated 4.

Comparison to Other Anticoagulants

• Dabigatran has been shown to be at least as effective as warfarin in the treatment of PE, with a similar risk of bleeding 3.
• LMWHs have also been shown to be at least as effective as unfractionated heparin (UFH) in the treatment of PE, with a similar risk of bleeding 5.
• The choice of anticoagulant will depend on individual patient factors, such as renal function and bleeding risk, as well as the specific clinical scenario 6.

Clinical Scenarios

• In patients with high and intermediate to high PE risk, dabigatran may be recommended for the treatment and prevention of PE after catheter-directed thrombolysis with reduced-dose thrombolysis (RDT) 3.
• In patients with submassive PE, LMWHs are recommended over UFH due to their more predictable pharmacokinetics and anticoagulant effects 5.
• Outpatient treatment with LMWH has been shown to be feasible in many patients, and offers the potential for cost-savings and improvements in health-related quality of life 5.