April 5, 2012

Updated Labelling for Pradax Regarding Kidney Function and Risk of Bleeding

These notes are taken from the changes to the Canadian product monograph for the anticoagulant Pradax (dabigatran etexilate) which have been updated to include new recommendations regarding renal function.

Given that renal impairment is a risk factor for bleeding with Pradax®:

  • Prior to initiation of treatment, renal function should be assessed in all patients to exclude patients with severe renal impairment.
  • While on treatment, renal function should be assessed routinely in clinical situations when a decline in renal function may be suspected.
  • In elderly patients (older than 75 years) or in patients with moderate renal impairment, renal function should be assessed at least once a year.

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