US Dabigatran Label Updated With Renal Function Advice


November 09, 2011

November 9, 2011 (Ridgefield, Connecticut)— US physicians are being advised to assess renal function prior to prescribing dabigatran etexilate (Pradaxa, Boehringer Ingelheim) and to assess renal function in clinical situations that might be associated with declines in kidney function, according to the updated drug label.

Revisions to the label also include information on the storage and handling of dabigatran and recommendations on use with other medications, such as dronedarone and systemic ketoconazole.

Similar to a recent European Medicines Agency update, the revised label states that renal function should be assessed prior to starting therapy and tested annually in patients 75 years of age and those with creatinine clearance (CrCl) <50 mL/min. In addition, the label now states that physicians should consider using the 75-mg twice-daily dose in patients with moderate renal impairment who are also taking dronedarone or systemic ketoconazole. The concomitant use of dabigatran and permeability-glycoprotein inhibitors in patients with severe renal impairment (CrCl 15-30 mL/min) should be avoided.

The updated label now states that, once opened, dabigatran can be safely stored for four months, longer than the previous recommendation to use the medication within 30 days of opening the bottle, a recommendation subsequently extended to 60 days. In addition, the label states that INR testing should be avoided, as it is unreliable in patients treated with the anticoagulant.


An earlier version of this story incorrectly stated that dabigatran should not be prescribed in patients with severe renal impairment (CrCl 15-30 mL/min).