Interação entre Fenofibrato e Lovastatina

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.

Other lipid-lowering drugs (other fibrates or ≥ 1 g/day of niacin): Caution should be used when prescribing other fibrates or lipid-lowering doses (≥ 1 g/day) of niacin with lovastatin, as these agents can cause myopathy when given alone.

The benefit of further alterations in lipid levels by the combined use of lovastatin with other fibrates or niacin should be carefully weighed against the potential risks of these combinations.

Gemfibrozil Other fibrates Niacin (nicotinic acid) (≥ 1 g/day) Other Drug Interactions Cyclosporine The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine (see WARNINGS , Myopathy/Rhabdomyolysis ).