TROVAS

What it is

TROVAS contains atorvastatin calcium trihydrate and is available in 10 mg, 20 mg, 40 mg and 80 mg tablet strengths. 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 hypercholesterolaemia as an adjunct to diet. — Reduction of the risk of non-fatal myocardial infarction and non-fatal stroke 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.

Dosing overview

TROVAS 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. After initiation and/or upon titration of atorvastatin, lipid levels should be re-analysed within 4 weeks and dosage adjusted according to the patient's response. The majority of patients with primary hypercholesterolaemia and mixed dyslipidaemia are controlled with 10 mg atorvastatin once a day, with a therapeutic response evident within two weeks and maximum response usually achieved within four weeks. TROVAS is for oral administration and atorvastatin can be taken at any time of the day, with or without food.

Key safety warnings

Moderate elevations of serum transaminases have been reported with atorvastatin, with persistent increases >3 times the upper limit of normal occurring in 0.7% of patients in clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6% and 2.3% for 10 mg, 20 mg, 40 mg and 80 mg doses respectively. Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. Should an increase in ALT or AST of >3 times the upper limit of normal persist, reduction of dose or withdrawal of atorvastatin is recommended. Myalgia has been reported in atorvastatin-treated patients. Myopathy, defined as muscle ache or muscle weakness in conjunction with increases in creatine kinase values >10 times the upper limit of normal, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevation of creatine kinase. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Atorvastatin must not be co-administered with fusidic acid. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving concomitant fusidic acid and statins. A post-hoc analysis of a clinical study (SPARCL) 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 (2.3%) compared to placebo (1.4%). The increased risk of haemorrhagic stroke was observed in patients who entered the study with prior haemorrhagic stroke or prior lacunar infarct. The potential risk of haemorrhagic stroke should be carefully considered before initiating treatment with atorvastatin in patients with recent (1–6 months) stroke or transient ischaemic attack. 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. If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.

Contraindications

TROVAS is contraindicated in patients with hypersensitivity to any component of the medication, active liver disease or unexplained persistent elevations of serum transaminases, and pregnancy and lactation. TROVAS is contraindicated in women of childbearing potential, unless on an effective contraceptive and highly unlikely to conceive. TROVAS is contraindicated with concomitant use of fusidic acid hemihydrate. TROVAS is contraindicated with treatment with the hepatitis C antivirals, glecaprevir/pibrentasvir.

Regulatory history

TROVAS was first approved on 13 September 2011. TROVAS atorvastatin tablets in strengths of 10 mg, 20 mg, 40 mg and 80 mg were first listed on the ARTG on 23 September 2011 in both blister pack and bottle presentations.