Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2021 Publisher: Organon Pharma Pty Limited, Building A, 26 Talavera Road, Macquarie Park NSW 2113
ZIENT administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.
ZIENT, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
ZIENT is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.
ZIENT, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
(pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche)
ZIENT co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:
ZIENT co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).
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 or with a statin. ZIENT can be administered at any time of the day, with or without food.
ZIENT may be administered with a statin for incremental effect. For convenience, the daily dose of ZIENT may be taken at the same time as the statin, according to the dosing recommendations for the statin.
For incremental cardiovascular event reduction in patients with coronary heart disease, ZIENT 10 mg may be administered with a statin with proven cardiovascular benefit.
In patients with renal impairment, no dosage adjustment of ZIENT is necessary (see Section 5.2 Pharmacokinetic Properties, Characteristics in patients (special populations).
In patients with mild renal insufficiency (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. Efficacy and safety at higher doses has not been evaluated in this CKD population (see Section 4.4 Special Warnings and Precautions for Use, Characteristics in Patients [Special Populations], and Section 5.1 Pharmacodynamic Properties, Clinical trials, Prevention of Major Vascular Events in Chronic Kidney Disease (CKD)).
No dosage adjustment is required for elderly patients (see Section 5.2 Pharmacokinetic Properties, Characteristics in patients (special populations).
Initiation of treatment must be performed under review of a specialist.
The use of ZIENT co-administered with simvastatin in children and adolescent patients (10-17 years old) is recommended only for patients with Heterozygous Familial Hypercholesterolaemia (HeFH) or Homozygous Familial Hypercholesterolaemia (HoFH).
There are no clinical safety and efficacy data on the use of ZIENT co-administered with simvastatin in children and adolescent patients (10-17 years old) with non-familial hypercholesterolaemia, or mixed hyperlipidaemia.
Adolescents 10 to 17 years old (pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche): No dosage adjustment is required (see Section 5.2 Pharmacokinetic Properties, Characteristics in patients (special populations). The clinical experience in paediatric and adolescents patient (aged 10-17 years old) is however limited and mostly includes children and adolescents (10-17 years old) with Heterozygous Familial Hypercholesterolaemia. There are also no long-term (>1 year) safety data in this population.
ZIENT co-administered with simvastatin has not been studied in pre-menarchal girls or in prepubertal boys and is not recommended.
When ZIENT is administered with a statin, the dosage instructions for the statin in children should be followed.
Children <10 years: ZIENT is not recommended for use in children below 10 years of age. There are limited data on safety and efficacy in children 6-10 years of age. See Section 5.1 Pharmacodynamic Properties, Clinical trials, Clinical studies in paediatric (6 to 17 years of age) patients; Section 4.4 Special Warnings and Precautions for Use, Paediatric (6 to 17 years of age) patients, Section 4.8 Adverse Effects (Undesirable Effects), Paediatric (6 to 17 years of age) patients. There is no available data on use of ZIENT in children <6 years (see Section 5.2 Pharmacokinetic Properties, Characteristics in patients (special populations)). The use of ZIENT in combination with statins has not been studied in children <10 years of age.
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 Section 4.3 Contraindications, Section 4.4 Special Warnings and Precautions for Use and see Section 5.2 Pharmacokinetic Properties, Characteristics in patients (special populations)).
In clinical studies, administration of ezetimibe, 50 mg/day to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolemia for up to 56 days, was generally well tolerated.
A few cases of overdosage with ZIENT have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious. In the event of an overdose, symptomatic and supportive measures should be employed.
For information on the management of overdose of ZIENT, contact the Poison Information Centre on 131126 (Australia).
The expiry date can be found on the packaging. In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).
Store below 30°C. Store in the original package.
Supplied in blister packs of 5, 10 and 30.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
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