Dosing and Administration

Dosing and administration

• • The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.
• • 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, Apo B, and non–HDL-C in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia when diet alone is not enough.
• • Contraindications: hypersensitivity to any component of this medication.
• • Statin contraindications apply when used with a statin: active liver disease; unexplained persistent elevations in hepatic transaminase levels. Statins are contraindicated in pregnant and nursing women. Refer to the statin label for details.

See additional important information

Dosage is available in a convenient once-daily tablet

Easy to take

• • Can be taken with or without food
• • May be taken at the same time as any statin

Selected dosage information

• • No dosage adjustments necessary for
• — Mild hepatic insufficiency
• — Renal insufficiency
• — Elderly patients

• IMPORTANT INFORMATION ABOUT GERIATRIC PATIENTS
• • Of the patients who received ZETIA in clinical studies, 4,256 were 65 and older (this included 1,035 who were 75 and older). No overall differences in safety and effectiveness were observed between these patients and younger patients. Greater sensitivity of some older individuals cannot be ruled out.
• • No dosage adjustment is needed in geriatric patients.

• SELECTED CAUTIONARY INFORMATION
• • When using ZETIA with a statin, also follow the label recommendations for that specific statin.
• • When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (>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. Should an increase in ALT or AST >3 × ULN persist, consider withdrawal of ZETIA and/or the statin.
• • Patients should be advised to promptly report muscle pain, tenderness, or weakness. Risk for skeletal muscle toxicity increases with higher statin doses, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Discontinue drug if myopathy is diagnosed or suspected.
• • Because renal impairment is a risk factor for statin-associated myopathy, doses of simvastatin exceeding 20 mg should be used with caution and close monitoring when administered concomitantly with ZETIA in patients with moderate to severe renal impairment (eGFR <60 mL/min/1.73 m²).

Additional Important Safety Information

Before prescribing ZETIA, please read the Prescribing Information. The Patient Information also is available.