EZOLETA TABLETS 10MG [SIN16422P]

Product Info

EZOLETA TABLETS 10MG

[SIN16422P]

4.1 Therapeutic indications

Primary hypercholesterolemia
Ezoleta, 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 nonfamilial) hypercholesterolemia.

Ezoleta, 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 Hypercholesterolaemia (HoFH)
Ezoleta, 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 (eg. LDL apheresis) or if such treatments are unavailable.

Homozygous Sitosterolemia (Phytosterolemia)
Ezoleta is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

4.2 Posology and method of administration

Posology

The patient should be on an appropriate lipid lowering diet and should continue on this diet during treatment with Ezoleta.
The recommended dose is one Ezoleta 10 mg tablet daily. Ezoleta can be administered at any time of the day, with or without food.
When Ezoleta is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued. In this setting, the dosage instructions for that particular statin should be consulted.

Patients with Renal Impairment
Monotherapy
In patients with renal impairment, no dosage adjustment of Ezoleta is necessary (see section 5.2, 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 Ezoleta or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m², the dose of Ezoleta 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 section 5.2, Special populations and section 5.1 – 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 section 5.2, 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 section 5.2, Special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children <10 years: Treatment with Ezoleta 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 sections 4.4 and 5.2, 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 Ezoleta should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

4.3 Contraindications

Hypersensitivity to any component of this medication.

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

The combination of Ezoleta 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 Ezoleta is administered with a statin or with fenofibrate in a woman with childbearing potential, refer to the product labeling for that medication.