ROSUZET Composite Pack

What it is

ROSUZET Composite Pack is a composite pack containing ezetimibe 10 mg tablets and rosuvastatin calcium tablets. Ezetimibe is a lipid-modifying compound that inhibits the intestinal absorption of cholesterol and related plant sterols by targeting the sterol transporter Niemann-Pick C1-Like 1, which leads to a decrease in the delivery of intestinal cholesterol to the liver.

Approved indications

— As adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate (not controlled with monotherapy or already treated with both). — For patients with Homozygous Familial Hypercholesterolaemia.

Dosing overview

ROSUZET Composite Pack is available in four strength combinations: ezetimibe 10 mg with rosuvastatin calcium 5 mg, 10 mg, 20 mg, or 40 mg. Patients should be on an appropriate lipid-lowering diet and should continue on this diet during treatment.

Key safety warnings

There is sufficient evidence of a causal association between ezetimibe and drug-induced liver injury, and consecutive transaminase elevations (≥3 times the upper limit of normal) have been observed in controlled trials with ezetimibe and a statin. Liver function tests should be performed at initiation of therapy and as indicated or according to the recommendations of the statin. All patients starting therapy with ezetimibe should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, and ezetimibe and any statin should be immediately discontinued if myopathy is diagnosed or suspected. Myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs, and cases of myopathy and rhabdomyolysis have been reported in post-marketing experience with ezetimibe. Caution should be exercised when initiating ezetimibe in the setting of ciclosporin, and ciclosporin concentrations should be monitored in patients receiving both drugs.

Contraindications

Ezetimibe is contraindicated in patients with hypersensitivity to any component of this medication. Therapy with ezetimibe in combination with a statin is contraindicated during pregnancy and lactation. The combination of ezetimibe with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.

PBS listing

No PBS listing information is available in the provided source documents.

Regulatory history

ROSUZET Composite Pack was first listed on the ARTG on 2013-11-26 in four strength variants (ezetimibe 10 mg with rosuvastatin calcium 5 mg, 10 mg, 20 mg, and 40 mg) under licence category RE. The TGA approved the registration of the ezetimibe and rosuvastatin composite pack. The TGA found that all quality issues were satisfactorily resolved, there were no nonclinical objections to registration, and minor pharmacokinetic changes with co-administration were deemed clinically insignificant.