Fenofibrate is lipid-regulating agent indicated as adjunctive therapy to diet for the treatment of severe hypertriglyceridemia or primary hyperlipidemia in adults.
Fenofibrate is lipid-regulating agent indicated as adjunctive therapy to diet for the treatment of severe hypertriglyceridemia or primary hyperlipidemia in adults.
WARNINGS AND PRECAUTIONS
● Hepatotoxicity: Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrates, including fenofibrate tablets. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist. ( 5.2)
● Myopathy and Rhabdomyolysis: Have been reported in patients taking fenofibrate. Risks are increased during co-administration with a statin, in geriatric patients and in patients with renal impairment, or hypothyroidism. Discontinue fenofibrate tablets if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected.
Temporarily discontinue fenofibrate tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the fenofibrate tablets dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.3)
● Increases in Serum Creatinine: Monitor renal function in patients with renal impairment taking fenofibrate tablets. Consider monitoring renal function in patients at risk for renal impairment. ( 5.4)
● Cholelithiasis: Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated ( 5.5).
● Hypersensitivity Reactions: Acute hypersensitivity reactions, including anaphylaxis and angioedema, and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases were life-threatening and required emergency treatment. Discontinue fenofibrate tablets and treat appropriately if reactions occur ( 5.9).
Adverse reactions (> 2% and greater than 1% in placebo): abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis. ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma, LLC. at 1-888-927- 5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full Safety and Prescribing Information: DailyMed
