ROSUVASTATIN-WGR

What it is

ROSUVASTATIN-WGR contains rosuvastatin calcium in tablet strengths of 5 mg, 10 mg, 20 mg and 40 mg.

Approved indications

— Reduction of the risk of nonfatal myocardial infarction in men ≥50 years old and women ≥60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease. — Reduction of the risk of nonfatal stroke in men ≥50 years old and women ≥60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease. — Reduction of the risk of coronary artery revascularisation procedures in men ≥50 years old and women ≥60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease. — Treatment of hypercholesterolaemia, including familial hypercholesterolaemia.

Dosing overview

For hypercholesterolaemia, the recommended starting dose is 5 mg or 10 mg once per day in both statin naïve patients and those switched from another HMG-CoA reductase inhibitor. 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. 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 ROSUVASTATIN-WGR therapy with 5 mg once daily should be considered for Asian patients.

Key safety warnings

HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function, with the incidence of persistent elevations exceeding 3 times the upper limit of normal occurring on 2 or more consecutive occasions being 0.4%, 0%, 0%, and 0.1% in patients who received rosuvastatin 5, 10, 20, and 40 mg, respectively. Liver function tests should be performed before initiation of treatment and periodically thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with rosuvastatin and with other drugs in this class. Factors that may predispose patients to myopathy with HMG-CoA reductase inhibitors include advanced age (≥65 years), hypothyroidism, and renal insufficiency. 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 CK levels occur or myopathy is diagnosed or suspected. Fusidic acid must not be co-administered with statins, as there have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. Increases in HbA1c and serum glucose levels have been observed in patients treated with rosuvastatin, and an increased frequency of diabetes mellitus has been reported in patients with risk factors for diabetes mellitus.

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-WGR 40 mg is contraindicated in patients with pre-disposing 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, severe renal impairment, Asian patients, and concomitant use of fibrates.

Regulatory history

ROSUVASTATIN-WGR was first registered on the ARTG on 15 May 2020 in eight presentations: 5 mg tablets in bottles and blister packs, 10 mg tablets in bottles and blister packs, 20 mg tablets in bottles and blister packs, and 40 mg tablets in bottles and blister packs.