There is a risk of hepatotoxicity associated with the use of Juxtapid. Juxtapid can cause elevations in transaminases. Juxtapid also increases hepatic fat, with or without concomitant increases in transaminases. Hepatic steatosis associated with Juxtapid treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.
Therefore, in addition to tracking LDL-C levels while your patient is on Juxtapid, regular liver monitoring should also be performed.
Liver-Related Tests (AST and ALT)
Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiation of treatment with Juxtapid. After therapy with Juxtapid has been started, measure liver-related tests (ALT and AST, at a minimum) at the frequency below.
|During First Year:||Prior to each increase in dose or monthly, whichever occurs first.|
|After First Year:||At least every 3 months and before any increase in dose.|
In the event that ALT/AST elevations occur during therapy with Juxtapid, the recommendations below should be followed:
If transaminase elevations are accompanied by clinical symptoms of liver injury, (such a nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin ≥ 2x ULN, or active liver disease, discontinue treatment with JUXTAPID and investigate to identify the probable cause.