페노피브레이트

Fenofibrate capsules, USP are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) (1). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible (1). Limitations of Use: Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined (1). Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus (1). Fenofibrate Capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)] . Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized …

Fenofibrate is contraindicated in patients with: Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology (12.3)]. Active liver disease, including those with unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2)]. Pre-existing gallbladder disease [see Warnings and Precautions (5.5)]. Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate capsules. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate [see Warnings and Precautions (5.9)]. Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis (4) Active liver disease, including those with unexplained persistent liver function abnormalities (4) Pre-existing gallbladder disease (4) Hypersensitivity to fenofibrate fenofibric acid, or any of the excipients in fenofibrate capsules (4)

Hepatotoxicity: Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrates including fenofibrate capsules. 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 fenofibrates. Risks are increased during co-administration with a statin, in geriatric patients and in patients with renal impairment hypothyroidism. Discontinue fenofibrate capsules if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Temporarily discontinue fenofibrate capsules 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 rhabdomyolysis when starting or increasing the fenofibrate 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 capsules. 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 …

8.1 Pregnancy Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or comparable to the maximum recommended clinical dosage of 130 mg of fenofibrate daily, based on body surface area (mg/m 2 ). Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data). Fenofibrate should be used during pregnancy only if the potential …