Not to be started & discontinue treatment if creatine kinase (CK) levels are significantly elevated at baseline (>5x ULN). Discontinue treatment if myopathy is suspected; throughout duration of fusidic acid treatment in patients where use of this is essential; transaminase levels rise to 3x ULN & are persistent; patient develops ILD. Consider treatment discontinuation if muscular symptoms are severe & cause daily discomfort, even if CK levels are <5x ULN. Temporarily discontinue few days prior to elective major surgery & any major medical or surgical condition. Promptly interrupt therapy if serious liver injury &/or hyperbilirubinemia or jaundice occurs. Myopathy & rhabdomyolysis; immune-mediated necrotizing myopathy; hyperglycaemia; ILD; dizziness. Patients w/ history of MI; pre-disposing factors for rhabdomyolysis; previous muscle disorder on fibrate or statin; who consume substantial quantities of alcohol. Patients who are carriers of SLCO1B1 c.521T>C genotype. Measure CK level before starting treatment in patients w/ uncontrolled hypothyroidism, personal or familial history of hereditary muscular disorders, history of muscular toxicity w/ statin or fibrate, alcohol abuse, renal impairment, females & elderly ≥65 yr; if muscle pain, weakness or cramps occur while on treatment. Carefully monitor patients for signs & symptoms of muscle pain, tenderness or weakness during initial mth of therapy when combined w/ niacin (nicotinic acid); patients at risk of DM (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m
2, raised triglycerides, HTN). Monitor INR if used concomitantly w/ warfarin, another coumarin anticoagulant, or fluindione. Perform LFTs before treatment & when clinically indicated thereafter. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ potent CYP3A4 inhibitors; ciclosporin, danazol, gemfibrozil; other fibrates, niacin (≥1 g/day), amiodarone, amlodipine, verapamil or diltiazem; fluconazole; grapefruit juice; fusidic acid; lomitapide; BCRP inhibitors eg, elbasvir & grazoprevir; daptomycin; warfarin. Not recommended in patients w/ moderate (Child-Pugh score 7-9) or severe (Child-Pugh score >9) hepatic impairment. Not recommended in childn <10 yr. Asian patients (Chinese).