Ezetast

What it is

Ezetast is a film-coated tablet containing ezetimibe 10 mg and atorvastatin 10, 20, 40 or 80 mg. Four strengths are available: 10/10 mg, 10/20 mg, 10/40 mg, and 10/80 mg.

Approved indications

— Prevention of cardiovascular disease in patients with coronary heart disease and a history of acute coronary syndrome taking their maximum tolerated dose of atorvastatin and in need of additional lowering of LDL-C. — Primary hypercholesterolaemia as adjunctive therapy to diet in patients with heterozygous familial and non-familial hypercholesterolaemia not appropriately controlled with atorvastatin or ezetimibe alone, or already treated with atorvastatin and ezetimibe. — Homozygous familial hypercholesterolaemia.

Dosing overview

This combination product is not indicated for first-line use. Patients should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetast. Ezetast can be administered at any time of the day, with or without food. After initiation and/or upon titration of Ezetast, lipid levels should be re-analysed within 2 or more weeks and dosage adjusted according to the patient's response.

Key safety warnings

Moderate elevations of serum transaminases have been reported following therapy with atorvastatin, with persistent increases in serum transaminases greater than 3 times the upper limit of normal occurring in 0.7% of patients in clinical trials, with incidence varying by dose from 0.2% at 10 mg to 2.3% at 80 mg. Liver function tests should be performed before the initiation of treatment and periodically thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin, and a history of renal impairment may be a risk factor for the development of rhabdomyolysis, with such patients meriting closer monitoring for skeletal muscle effects. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of creatine kinase, and patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Ezetimibe/Atorvastatin.

Contraindications

Hypersensitivity to any component of this medication. Myopathy secondary to other lipid lowering agents. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy and lactation, and women of childbearing potential unless on an effective contraceptive and highly unlikely to conceive. Concomitant use with fusidic acid.

Regulatory history

Ezetast 10/10 mg, 10/20 mg, 10/40 mg, and 10/80 mg tablets were first listed on the ARTG on 1 November 2019 under licence category RE.