Interaksi Fenofibrat dan Fluvastatin

Risks are increased during co-administration with a statin, in geriatric patients and in patients with renal impairment, or hypothyroidism.

Pemafibrate did not reduce cardiovascular disease morbidity or mortality in a large, randomized, placebo - controlled trial of patients with type 2 diabetes mellitus on background statin therapy [see Clinical Studies (14.4) ].

Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Data from observational studies indicate that the risk for rhabdomyolysis is increased when fibrates, including fenofibrates, are co-administered with a statin.

The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins.

Intervention: Consider if the benefit of using fenofibrate concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis.

When used concomitantly with fluvastatin sodium extended-release tablets, lipid modifying doses (≥ 1 g/day) of niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions ( 7.1 )] .

• Fibrates, Lipid-modifying doses (≥ 1 g/day) of Niacin, and Colchicine : Consider if the benefit of concomitant use with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis.

The risk of myopathy and rhabdomyolysis may be increased with concomitant use of fibrates with fluvastatin sodium extended-release tablets.

Intervention Consider if the benefit of using fibrates concomitantly with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis.

Fibrates Clinical impact Fibrates may cause myopathy when given alone.