Fenofibrate

Warnings and Precautions, Heptatotoxicity (5.2)                                  02/2021    

Warnings and Precautions, Myopathy and rhabdomyolysis (5.3)         02/2021        

Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:

• To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
• For treatment of adult patients with severe hypertriglyceridemia (1.2).

Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).

• Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 160 mg once daily (2.2).
• Severe hypertriglyceridemia: Initial dose of 54 to 160 mg once daily. Maximum dose is 160 mg (2.3).
• Renally impaired patients: Initial dose of 54 mg once daily (2.4).
• Geriatric patients: Select the dose on the basis of renal function (2.5).
• Should be given with meals (2.1).

• Fenofibrate tablets USP, 54 mg are yellow to light yellow colored, oval shape, film-coated tablets debossed with ‘L751’ on one side and plain on other side.
• Fenofibrate tablets USP, 160 mg are white to off white, oval shape, film-coated tablets debossed with ‘L752’ on one side and plain on other side.

• Geriatric Use: Determine dose selection based on renal function (8.5).
• Renal Impairment: Avoid use in severe renal impairment patients. Dose reduction is required in mild to moderate renal impairment patients (8.6).