Possible effects on skeletal muscle (eg, myalgia, myopathy & rarely rhabdomyolysis) in rosuvastatin-treated patients w/ all doses particularly >20 mg. Immediately discontinue concomitant use of ezetimibe, any statin or agents known to be associated w/ increased risk of rhabdomyolysis if myopathy is suspected based on muscle symptoms or confirmed by creatine kinase (CK) level. Advise patients to promptly report any unexplained muscle pain, tenderness or weakness. Possible myasthenia gravis or ocular myasthenia; discontinue use in case of symptom aggravation. CK should not be measured following strenuous exercise or in presence of plausible alternative cause of CK increase. Carry out confirmatory test w/in 5-7 days if CK levels are significantly elevated at baseline (>10x ULN); treatment should not be started if the repeat test confirms baseline CK >10x ULN. Treat underlying disease in patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome prior to initiating therapy. Carry out LFTs 3 mth following rosuvastatin treatment initiation, any increase of dose & periodically (semi-annually) thereafter; discontinue rosuvastatin or reduce its dose if serum transaminase level is >3x ULN. Possible proteinuria in higher doses of rosuvastatin particularly 40 mg; consider renal function assessment at least every 3 mth during routine follow-up of patients treated w/ 40 mg. Consider risk of treatment in relation to possible benefit & clinical monitoring in patients w/ pre-disposing factors for myopathy/rhabdomyolysis (eg, renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, history of muscular toxicity w/ another HMG-CoA reductase inhibitor, fibrate or niacin, alcohol abuse, >65 yr, situations where increased plasma levels may occur, concomitant use of fibrates or niacin). Not recommended in combination w/ gemfibrozil; certain PIs (eg, ritonavir). Temporarily w/hold in any patient w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, or uncontrolled seizures). Avoid co-administration w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment; advise patient to immediately seek medical advice if any symptoms of muscle weakness, pain or tenderness occur. Increased exposure in Asian subjects including Japanese, Chinese, Malay & Indian ancestry. Discontinue use if patient has developed ILD. May raise blood glucose; monitor patients at risk of DM (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m
2, raised triglycerides, HTN). Gallbladder investigations are indicated & discontinue use if cholelithiasis is suspected in patient receiving RoZevon & fenofibrate. Monitor INR if RoZevon is added to warfarin, another coumarin anticoagulant or fluindione. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Contains lactose; not to be used in patients w/ rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. Not suitable for initial therapy. Possible increased rosuvastatin exposure in genotypes of SLCO1B1 (OATP1B1) c.521CC & ABCG2 (BCRP) c.421AA. Not suitable for initial therapy in patients w/ renal insufficiency. Not recommended in patients w/ moderate or severe hepatic insufficiency. Dizziness may occur during treatment. Not recommended in childn <18 yr.
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