Wechselwirkung zwischen Ezetimib und Simvastatin und Fenofibrat

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.

Fenofibrates: Combination increases exposure of ezetimibe.

If cholelithiasis is suspected in a patient receiving ezetimibe and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.

Fenofibrates Clinical Impact: Both ezetimibe and fenofibrates may increase cholesterol excretion into the bile, leading to cholelithiasis.

Intervention: If cholelithiasis is suspected in a patient receiving VYTORIN and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered [see the product labeling for fenofibrate and fenofibric acid] .

However, rhabdomyolysis has been reported with ezetimibe monotherapy and with the addition of ezetimibe to agents known to be associated with increased risk of rhabdomyolysis, such as fibric acid derivatives.