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ZETIA, administered alone or in combination with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, and Apo B in patients with primary (heterozygous familial and nonfamilial) hypercholesterolemia when diet alone is not enough.

Contraindications: hypersensitivity to any component of this medication. Contraindications when used with a statin: active liver disease; unexplained persistent elevations of serum transaminases. Statins are contraindicated in pregnant and nursing women; refer to the statin label for details.

When ZETIA was coadministered with a statin, consecutive elevations in serum transaminases (>3 × ULN) were slightly higher (1.3%) than those of statins alone (0.4%). Liver function tests should be performed when ZETIA is added to statin therapy and according to statin recommendations.

In postmarketing experience with ZETIA, cases of myopathy and rhabdomyolysis have been reported regardless of causality. Most patients who developed rhabdomyolysis were taking a statin before initiating ZETIA. However, rhabdomyolysis has been reported very rarely with ZETIA monotherapy or with the addition of ZETIA to agents associated with increased risk of rhabdomyolysis, such as fibrates. Tell patients to promptly report muscle pain, tenderness, or weakness. Discontinue ZETIA and any statin or fibrate if myopathy is diagnosed or suspected.

ZETIA is not recommended in patients with moderate or severe hepatic insufficiency.

ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.

The safety and effectiveness of ZETIA with fibrates have not been established; therefore, coadministration with fibrates is not recommended until use in patients is studied.

The effects of ZETIA, either alone or in addition to a statin, on the risk of cardiovascular morbidity and mortality have not been established.

The independent effect of raising HDL-C or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.

When using ZETIA with a statin, also follow the label recommendations for that specific statin.

In clinical trials, most frequent side effects for ZETIA alone vs placebo included: back pain (4.1% vs 3.9%) and arthralgia (3.8% vs 3.4%); for ZETIA + statin vs statin or placebo alone: back pain (4.3% vs 3.7% vs 3.5%) and abdominal pain (3.5% vs 3.1% vs 2.3%).

Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.