Trilipix is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to:

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

Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of Trilipix did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).

• Hypertriglyceridemia: 45 to 135 mg once daily (2.2).
• Primary hypercholesterolemia or mixed dyslipidemia: 135 mg once daily (2.3).
• Renally impaired patients: 45 mg once daily (2.4).
• Maximum dose: 135 mg once daily (2.1).
• May be taken without regard to food (2.1).

Oral Delayed Release Capsules: 45 mg and 135 mg (3).
CONTRAINDICATIONS

• Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks for myopathy and rhabdomyolysis are increased in elderly patients; patients with diabetes, renal failure, or hypothyroidism; and patients being treated with a statin (5.2).
• Trilipix can increase serum transaminases. Liver tests should be monitored periodically (5.3).
• Trilipix can reversibly increase serum creatinine levels (5.4). Renal function should be monitored periodically in patients with renal insufficiency (8.6).
• Trilipix increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated (5.5).
• Exercise caution in concomitant treatment with oral coumarin anticoagulants. Adjust the dosage of coumarin anticoagulant to maintain the prothrombin time/INR at the desired level to prevent bleeding complications (5.6).

The most common adverse events reported during clinical trials with fenofibrate (≥ 2% and at least 1% greater than placebo) were abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis (6.1).
 

To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

• Coumarin Anticoagulants: (7.1).
• Bile Acid Binding Resins: (7.2).
• Immunosuppressants: (7.3).

• Geriatric Use: Dose selection for the elderly should be made on the basis of renal function (8.5).
• Renal Impairment: Trilipix should be avoided in patients with severe renal impairment. Dose adjustment is required in patients with mild to moderate renal impairment (8.6).