LIPITOR

What it is

LIPITOR contains atorvastatin as calcium trihydrate, available in 10 mg, 20 mg, 40 mg and 80 mg tablet strengths. LIPITOR is supplied as white, round, film-coated tablets. Atorvastatin is a synthetic lipid-lowering agent and an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of sterols including cholesterol.

Approved indications

— Treatment of patients with hypercholesterolaemia, as an adjunct to diet. — In hypertensive patients with multiple risk factors for coronary heart disease (which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic coronary heart disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.

Dosing overview

LIPITOR can be administered within the dosage range of 10 mg to 80 mg per day as a single daily dose. Therapy should be individualised according to the target lipid levels, the recommended goal of therapy and the patient's response. The majority of patients are controlled with 10 mg LIPITOR once daily, with a therapeutic response evident within 2 weeks and the maximum response usually achieved within 4 weeks. LIPITOR is for oral administration and can be taken at any time of the day, with or without food.

Key safety warnings

Moderate elevations of serum transaminases have been reported following therapy with atorvastatin, with persistent increases greater than 3 times upper limit of normal occurring in 0.7% of patients in clinical trials, with incidence of 0.2%, 0.2%, 0.6% and 2.3% for the 10 mg, 20 mg, 40 mg and 80 mg doses respectively. Liver function tests should be performed before initiation of treatment and periodically thereafter, with patients who develop increased transaminase levels monitored until abnormalities resolve, and reduction of dose or withdrawal recommended if an increase in ALT or AST greater than 3 times upper limit of normal persists. Uncomplicated myalgia has been reported in atorvastatin-treated patients, and myopathy (defined as muscle ache or muscle weakness in conjunction with increases in creatine kinase greater than 10 times upper limit of normal) should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and marked elevation of creatine kinase, with patients advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. LIPITOR therapy should be discontinued if markedly elevated creatine kinase levels occur or if myopathy is diagnosed or suspected, with the risk of myopathy and rhabdomyolysis increased with concurrent administration of drugs that increase the systemic concentration of atorvastatin. A post-hoc analysis of a clinical study in patients without known coronary heart disease who had a recent stroke or transient ischaemic attack showed a higher incidence of haemorrhagic stroke in patients on atorvastatin 80 mg compared to placebo, and the potential risk of haemorrhagic stroke should be carefully considered before initiating treatment with atorvastatin in patients with recent stroke or transient ischaemic attack.

Contraindications

Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy and lactation, and women of childbearing potential unless on an effective contraceptive and highly unlikely to conceive. Concomitant use with fusidic acid hemihydrate. Treatment with the Hepatitis C antivirals, glecaprevir/pibrentasvir.

PBS listing

LIPITOR is listed on the PBS in 10 mg, 20 mg, 40 mg and 80 mg tablet strengths with multiple restriction types (restricted and unrestricted), with ex-manufacturer prices of A$2.50 (10 mg), A$2.60 (20 mg), A$3.45 (40 mg) and A$4.00 (80 mg) respectively.

Regulatory history

LIPITOR was first approved on 25 September 1997. ARTG registration records show LIPITOR atorvastatin tablets in 10 mg, 20 mg, 40 mg and 80 mg strengths as calcium trihydrate tablet blister packs were first listed on 2 March 2011 with licence category RE.