August 25, 2016

REVOLADE administration can cause severe hepatotoxicity and potentially fatal liver injury. Cases of severe drug-induced liver injury with REVOLADE have been reported in patients during clinical trials and post-marketing.

To mitigate the risk of severe hepatotoxicity and potentially fatal liver injury, healthcare professionals should: measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin prior to initiation of REVOLADE, every 2 weeks during the dose adjustment phase, and then monthly following establishment of a stable dose. Discontinue REVOLADE if ALT levels: increase greater than or equal to 3x upper limit of normal (ULN) in patients with normal liver function or; increase greater than or equal to 3x baseline or greater than 5x ULN, whichever is the lower, in patients with elevations in transaminases before treatment.

The Canadian Product Monograph for REVOLADE has been updated to reflect this new safety information.