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Skeletal Muscles: Fibrate and statin monotherapy increase the risk of myositis or myopathy, and have been associated with rhabdomyolysis. Data from observational studies suggest that the risk for rhabdomyolysis is increased when fibrates are co-administered with a statin. Refer to the respective statin labeling for important drug-drug interactions that increase statin levels and could increase this risk. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal failure or hypothyroidism. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevations of CPK levels. Patients should promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. CPK levels should be assessed in patients reporting these symptoms, and Trilipix and statin therapy should be discontinued if markedly elevated CPK levels (level exceeding 5 times the upper limit of the normal range) occur or myopathy or myositis is diagnosed.
Renal Function: Reversible elevations in serum creatinine have been reported in patients receiving Trilipix as monotherapy or co-administered with statins as well as patients receiving fenofibrate. Elevations in serum creatinine were generally stable over time with no evidence for continued increases in serum creatinine with long-term therapy and tended to return to baseline following discontinuation of treatment. The clinical significance of these observations is unknown. Monitoring renal function in patients with renal impairment taking Trilipix is suggested. Renal monitoring should be considered for patients at risk for renal insufficiency, eg, the elderly and those with diabetes. Treatment should be interrupted in case of an increase in creatinine levels of >50% upper limit of normal. It is recommended that creatinine is measured during the first 3 months after initiation of treatment and thereafter periodically.
Liver Function: Trilipix at a dose of 135 mg once daily administered as monotherapy or co-administered with low to moderate doses of statins has been associated with increases in serum transaminases [aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT)]. Hepatocellular, chronic active and cholestatic hepatitis observed with fenofibrate therapy have been reported after exposures of weeks to several years. In extremely rare cases, cirrhosis has been reported in association with chronic active hepatitis.
Regular monitoring of liver function including serum ALT (SGPT) and AST (SGPT) should be performed periodically for the duration of therapy with Trilipix, and therapy discontinued if enzyme levels persist >3 times the upper limit of normal.
Pancreatitis: Pancreatitis has been reported in patients taking drugs of the fibrate class, including Trilipix. This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.
Use in Pregnancy: There are no adequate data from the use of Trilipix in pregnant women. The potential risk for humans is unknown. Trilipix should not be used during pregnancy unless clearly necessary.
Effects on the Ability to Drive or Operate Machinery: Trilipix has no or negligible influence on the ability to drive and use machines.
Use in Lactation: It is unknown whether fenofibric acid is excreted in human breast milk. The excretion of fenofibric acid in milk has not been studied in animals. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with Trilipix should be made taking into account the benefit of breastfeeding to the child and the benefit of Trilipix therapy to the woman.
Use in Children: Trilipix is not recommended for use in children <18 years due to lack of data on safety and efficacy.
