Published: 7 June 2019

Publications

Dabigatran – Reduced dose recommendations

Prescriber Update 40(2): 28
June 2019

The dabigatran (Pradaxa) dose recommendations for the treatment/prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) are changing. The new recommendations concern elderly patients, patients with moderate renal impairment (creatinine clearance [CrCl]: 30–50 mL/min), and patients at risk of bleeding with one or more risk factors (Table 1).

Table 1: Summary of new dabigatran dose recommendations in the treatment/prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) indications

Special population New dose recommendation Previous dose recommendation
Patients aged ≥80 years 110 mg twice daily 150 mg twice daily
Patients aged 75–80 years 110 mg twice daily* OR 150 mg twice daily 150 mg twice daily
Patients with moderate renal impairment (CrCl 30–50 mL/min) 110 mg twice daily* OR 150 mg twice daily 150 mg twice daily
Patients at risk of bleeding with one or more risk factors 110 mg twice daily OR 150 mg twice daily 150 mg twice daily

* Use the lower recommended dose for patients with a lower thromboembolic risk and high bleeding risk.

Dabigatran dose recommendations were discussed at the December 2018 Medicines Adverse Reactions Committee meeting. The Committee recommended harmonising the recommendations for reduced dabigatran dose for the DVT and PE indications with those for the SPAF indication (SPAF: prevention of stroke, systemic embolism and reduction of vascular mortality in patients with atrial fibrillation).

Medsafe is working with the sponsor to update the Pradaxa data sheet. Full prescribing information will be available in the Pradaxa data sheet in the coming weeks.

0 1 2 4 5 6 7 9 [ /