Fenofibrate / Simvastatin

What it is and how it works

Fenofibrate (as fenofibric acid) activates peroxisome proliferator-activated receptor alpha (PPARα), increasing lipoprotein lipase activity and fatty acid oxidation, lowering triglycerides and raising HDL-cholesterol. Simvastatin inhibits HMG-CoA reductase, reducing hepatic cholesterol synthesis and LDL-cholesterol.

Indications

Adjunct to diet and exercise in adults at high cardiovascular risk with mixed dyslipidaemia, to reduce triglycerides and increase HDL-cholesterol when LDL-cholesterol is adequately controlled with the corresponding simvastatin dose alone.

Dosage and administration (summary)

Oral, one tablet (fenofibrate 145 mg with simvastatin 20 mg or 40 mg) once daily, usually in the evening, with or without food.

Contraindications

Hepatic impairment or unexplained persistent transaminase rise, moderate to severe renal impairment, gallbladder disease, chronic or acute pancreatitis (except that due to severe hypertriglyceridaemia), history of myopathy or photoallergy to fibrates or ketoprofen, concomitant strong CYP3A4 inhibitors, gemfibrozil, ciclosporin or danazol, pregnancy and breastfeeding.

Warnings and precautions

Combining a fibrate with a statin increases the risk of myopathy and rhabdomyolysis, particularly in the elderly, in renal impairment, hypothyroidism and with interacting drugs; creatine kinase should be checked if muscle symptoms occur. Liver function and renal function should be monitored, and fenofibrate may increase the risk of cholelithiasis, pancreatitis and venous thromboembolism.

Pregnancy

Contraindicated in pregnancy.

Storage and supply

Store below 30 °C in the original package.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.