ROSUVACOR

What it is

ROSUVACOR contains rosuvastatin calcium in strengths of 5 mg, 10 mg, 20 mg and 40 mg. Rosuvastatin calcium is a HMG-CoA reductase inhibitor, 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 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

The recommended starting dose is 5 mg or 10 mg once per day in both statin naive 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, particularly in patients with familial hypercholesterolaemia. Initiation of ROSUVACOR therapy with 5 mg once daily should be considered for Asian patients, as the potential for increased systemic exposures relative to Caucasians is relevant when considering escalation of dose.

Key safety warnings

HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function. The incidence of persistent elevations exceeding 3 times the upper limit of normal in serum transaminases was low across all doses studied, and in most cases, elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy. 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. Reports of rhabdomyolysis with rosuvastatin are rare, but higher at the highest marketed dose of 40 mg. Factors that may predispose patients to myopathy with HMG-CoA reductase inhibitors include advanced age of 65 years or older, hypothyroidism, and renal insufficiency. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Rosuvastatin therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. Increases in HbA1c and serum glucose levels have been observed in patients treated 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, with presenting features including dyspnoea, non-productive cough and deterioration in general health. If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.

Contraindications

ROSUVACOR is contraindicated in patients with known hypersensitivity to any of the ingredients. ROSUVACOR is contraindicated in 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. ROSUVACOR is contraindicated during pregnancy, in nursing mothers and in women of childbearing potential, unless they are taking adequate contraceptive precautions. Concomitant use of fusidic acid is contraindicated. ROSUVACOR 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 with creatinine clearance less than 30 mL/min, Asian patients, and concomitant use of fibrates.

PBS listing

Information regarding PBS listing for ROSUVACOR is not available in the provided source documents.

Regulatory history

ROSUVACOR was first listed on the ARTG on 23 May 2022, with registrations for 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets in both blister pack and bottle pack presentations.