APO-ROSUVASTATIN

What it is

APO-ROSUVASTATIN tablets contain 5 mg, 10 mg, 20 mg and 40 mg of rosuvastatin (as calcium). Rosuvastatin calcium is a HMG-CoA reductase inhibitor and 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

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

Dosing overview

The recommended starting dose is 5 mg or 10 mg once per day both in 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. This may particularly apply to patients with familial hypercholesterolaemia. For prevention of cardiovascular events, a dose of 20 mg once daily has been found to reduce the risk of major cardiovascular events. Initiation of therapy with 5 mg once daily should be considered for Asian patients.

Key safety warnings

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. Fusidic acid must not be co-administered with statins. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. Liver function tests should be performed before initiation of treatment and periodically thereafter. Should an increase in ALT or AST of greater than 3 times upper limit of normal persist, reduction of dose or withdrawal of rosuvastatin is recommended. Increases in HbA1c and fasting serum glucose levels have been reported with rosuvastatin. An increased frequency of diabetes mellitus has been reported with rosuvastatin in patients with risk factors for diabetes mellitus. Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy. Presenting features can include 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. APO-ROSUVASTATIN 40 mg is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis. Such factors include: 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 (CrCl less than 30 mL/min), Asian patients, and concomitant use of fibrates.

PBS listing

PBS listing information for APO-ROSUVASTATIN is not contained in the provided source documents.

Regulatory history

APO-ROSUVASTATIN 5 mg, 10 mg, 20 mg and 40 mg tablets were first listed on the ARTG on 3 March 2022.