CRESTABS

What it is

CRESTABS contains rosuvastatin calcium in film-coated tablets of 10 mg, 20 mg and 40 mg strength. Rosuvastatin calcium is an HMG-CoA reductase inhibitor for the treatment of dyslipidaemia and is a fully synthetic competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.

Approved indications —

Prevention of major cardiovascular events in men aged 50 years or older and women aged 60 years or older with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL cholesterol, smoking, or a family history of premature coronary heart disease) — Reduction of the risk of nonfatal myocardial infarction — Reduction of the risk of nonfatal stroke — Reduction of the risk of coronary artery revascularisation procedures — Treatment of hypercholesterolaemia (including familial hypercholesterolaemia)

Dosing overview

CRESTABS may be given at any time of the day, with or without food. **Hypercholesterolaemia.** The recommended starting dose is 5 mg or 10 mg once per day in both statin naïve patients and in those switched from another HMG-CoA reductase inhibitor. A dose adjustment can be made after 4 weeks of therapy where necessary. The usual maximum dose of rosuvastatin is 20 mg once per day. A dose of 40 mg once per day should only be considered in patients who are still at high cardiovascular risk after their response to a dose of 20 mg once per day is assessed, which may particularly apply to patients with familial hypercholesterolaemia. **Prevention of cardiovascular events.** A dose of 20 mg once daily has been found to reduce the risk of major cardiovascular events. **Special populations.** In patients taking ciclosporin, rosuvastatin dosage should be limited to 5 mg once daily. If CRESTABS is used in combination with gemfibrozil, the dose of CRESTABS should be limited to 10 mg once daily. For patients with severe renal impairment (creatinine clearance less than 30 mL/min/1.73 m²) not on dialysis, the dose of rosuvastatin should be started at 5 mg once daily and not exceed 10 mg once daily.

Key safety warnings

**Myopathy and rhabdomyolysis.** Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with rosuvastatin and with other drugs in this class. Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age and hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and rosuvastatin therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. The risk of myopathy during treatment with rosuvastatin may be increased with concurrent administration of other lipid-lowering therapies, protease inhibitors, or ciclosporin, and the benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination, with combination therapy with rosuvastatin and gemfibrozil generally being avoided. Fusidic acid must not be co-administered with statins, as there have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. **Liver effects.** Liver function tests should be performed before initiation of treatment and periodically thereafter, and patients who develop increased transaminase levels should be monitored until the abnormalities have resolved. Should an increase in alanine aminotransferase or aspartate aminotransferase of more than 3 times the upper limit of normal persist, reduction of dose or withdrawal of rosuvastatin is recommended. **Diabetes.** Increases in HbA1c and serum glucose levels have been observed in patients treated with rosuvastatin, including increases that exceeded the threshold for the diagnosis of diabetes mellitus in some cases. **Interstitial lung disease.** Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy, with presenting features including dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever).

Contraindications

Known hypersensitivity to any of the ingredients. Patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal. During pregnancy, in nursing mothers and in women of childbearing potential, unless they are taking adequate contraceptive precautions. Concomitant use of fusidic acid. Rosuvastatin 40 mg is contraindicated in patients with predisposing factors for myopathy or rhabdomyolysis, including hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in rosuvastatin plasma levels may occur, severe renal impairment (creatinine clearance less than 30 mL/min), Asian patients, and concomitant use of fibrates.

PBS listing

No information regarding PBS listing status, item number, restriction type, or ex-manufacturer price is available in the provided sources.

Regulatory history

CRESTABS was first registered on the Australian Register of Therapeutic Goods on 23 May 2022, with registrations for 10 mg, 20 mg and 40 mg film-coated tablets in both blister pack and bottle pack configurations (ARTG entries 363431, 363425, 363418, 363413, 363416 and 363430).