ZIENT TABLET 10MG

III. INDICATIONS

Primary Hypercholesterolemia

ZIENT, administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.

ZIENT, administered in combination with fenofibrate, 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 mixed hyperlipidemia.

Homozygous Familial Hypercholesterolemia (HoFH)

ZIENT, administered with atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Homozygous Sitosterolemia (Phytosterolemia)

ZIENT is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

VI. CONTRAINDICATIONS

Hypersensitivity to any component of this medication.

When ZIENT is to be administered with a statin or with fenofibrate, please refer to the Package Insert for that particular medication.

The combination of ZIENT with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.

All statins and fenofibrate are contraindicated in pregnant and nursing women. When ZIENT is administered with a statin or with fenofibrate in a woman with childbearing potential, refer to the product labeling for that medication.

V. DOSAGE AND ADMINISTRATION

The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ZIENT.

The recommended dose of ZIENT is 10 mg once daily, used alone, with a statin, or with fenofibrate. ZIENT can be administered at any time of the day, with or without food.

Patients with Renal Impairment

Monotherapy

In patients with renal impairment, no dosage adjustment of ZIENT is necessary (see IVb-5. Characteristics in Patients (Special Populations) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Combination Therapy with Simvastatin

In patients with mild renal impairment (estimated GFR ≥60 mL/min/1.73 m2), no dosage adjustment of ZIENT or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m2, the dose of ZIENT is 10 mg and the dose of simvastatin is 20 mg once a day in the evening. In such patients, the use of higher doses of simvastatin should be closely monitored (see VII. PRECAUTIONS, IVb-5. Characteristics in Patients (Special Populations) and IVc. CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in the Elderly

No dosage adjustment is required for elderly patients (see IVb-5. Characteristics in Patients (Special Populations) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Pediatric Patients

Children and adolescents ≥10 years: No dosage adjustment is required (see IVb-5. Characteristics in Patients (Special Populations) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children <10 years: Treatment with ZIENT is not recommended.

Use in Hepatic Impairment

No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6). Treatment with ezetimibe is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction (see VII. PRECAUTIONS and IVb-5. Characteristics in Patients (Special Populations) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Co-administration with bile acid sequestrants

Dosing of ZIENT should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.