Interação entre Ezetimiba + sinvastatina e Ácido fenofíbrico

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.

Lipid modifying doses (≥1 gram/day) of niacin, fibrates, colchicine, and grapefruit juice may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1) ] .

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

Intervention: Consider if the benefit of using fibrates concomitantly with VYTORIN outweighs the increased risk of myopathy and rhabdomyolysis.

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 fenofibric acid delayed-release capsules concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis.