Arrhythmia

Rivaroxaban gets approval for use in patients with renal impairment


Rivaroxaban (Xarelto) is now approved in Australia for patients with severe renal impairment down to a creatinine clearance of 15 mL/min.

The change brings the DOACs use in Australia into line with other countries including in Europe, the US and Canada.

Associate Professor Martin Gallagher, a nephrologist and program director of Acute Kidney Injury and Trials at the George Institute, told the limbic it was an important change.

“One of the biggest problems is that these drugs haven’t been really well tested in clinical trials with EGFR below 30. And there is a sizeable number of patients that we deal with, for example with AF, who have EGFR between 15 and 30.”

“So it has meaningful clinical implications because it widens our options for treatment.”

A/Professor Gallagher said all the DOACs were slightly different in their hepatic and renal metabolism.

“One of the advantages of rivaroxaban for its use in kidney disease patients is that about two-thirds of the dose is metabolised by the liver and only one-third of the parent drug is excreted renally.”

“So that means that the half life of the drug is not a lot different with reasonably advanced kidney disease which likely makes it safer.”

“We think it’s a good thing because the absolute risk of embolic events with AF goes up as their renal function gets worse so these drugs may have bigger absolute benefits in EGFR 15-30 than they do in EGFR 30-45.”

He said Australian clinicians have been very cautious about their use of DOACs in patients with kidney disease.

Rivaroxaban’s Product Information has been updated to reflect the change which applies to 20 mg, 15 mg and 10 mg dosing for the following indications:

  • Prevention of stroke and systemic embolism in patients with non-valvular AF and at least one additional risk factor for stroke
  • Treatment of DVT and PE and for the prevention of recurrent DVT and PE
  • Prevention of VTE in adults who have undergone major orthopaedic surgery of the lower limbs.

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