Mipomersen Disease Interactions

Mipomersen is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or active liver disease, including unexplained persistent elevations of serum transaminases. This agent can cause elevations in transaminases and hepatic steatosis, and could induce steatohepatitis, which could progress to cirrhosis. It is recommended to measure a full liver panel to include ALT, AST, total bilirubin, and alkaline phosphatase before initiation of treatment. If transaminase elevations are accompanied by clinical symptoms of liver injury (e.g., nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin >= 2 times ULN, or active liver disease, discontinue treatment and identify the probable cause.

The use of mipomersen is not recommended in patients with severe renal impairment, clinically significant proteinuria or on renal dialysis. The safety and efficacy of this agent has not been established in patients with renal impairment or undergoing renal dialysis. Care should be exercised when using this agent in patients with renal dysfunction.