Immediately discontinue use if signs & symptoms of severe skin reactions appear. Not suitable for initial therapy. Possible skeletal muscle effects (eg, myalgia, myopathy & rarely rhabdomyolysis) in rosuvastatin-treated patients. Possible
de novo or aggravated pre-existing myasthenia gravis or ocular myasthenia; discontinue use in case of symptom aggravation. Immediately discontinue use if myopathy is suspected based on muscle symptoms or confirmed by creatine kinase (CK) level, ezetimibe, statin or any agents known to be associated w/ increased risk of rhabdomyolysis. Carry out confirmatory test w/in 5-7 days if CK levels are significantly elevated at baseline (>10x ULN); do not start treatment if repeat test confirms baseline CK >10x ULN. Patients w/ pre-disposing factors for myopathy/rhabdomyolysis (eg, renal impairment, hypothyroidism, personal/family history of hereditary muscular disorders, history of muscular toxicity w/ another HMG-CoA reductase inhibitor, fibrate or niacin, alcohol abuse, age ≥65 yr, situations where increased plasma levels may occur, concomitant use of fibrates or niacin). Treat underlying disease in patients w/ secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome prior to initiating therapy. Advise patients to immediately report inexplicable muscle pain, weakness or cramps particularly if associated w/ malaise or fever; measure CK levels. Discontinue therapy if CK levels are markedly elevated (>10x ULN) or if muscular symptoms are severe & cause daily discomfort (even if CK levels are ≤10x ULN). Not recommended to use concomitantly w/ gemfibrozil. Carefully weigh benefit of further alterations in lipid levels against potential risks when combined w/ fibrates. Not to be used 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). Recommended to carry out LFTs 3 mth following initiation of rosuvastatin, any dose increase & periodically (semi-annually) thereafter. Discontinue or reduce dose of rosuvastatin if serum transaminase levels is >3x ULN. Recommended to assess renal function during routine follow-up of patients treated w/ rosuvastatin 40 mg. Possible severe cutaneous AR including SJS & DRESS. Discontinue statin if patient developed ILD. Clinically & biochemically monitor patients at risk (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m
2, raised triglycerides, HTN). Lypstaplus should be taken ≥2 hr before or ≥4 hr after a bile acid sequestrant. Temporarily discontinue therapy when used concomitantly w/ ciclosporin & certain PIs including combinations of ritonavir w/ atazanavir, lopinavir &/or tipranavir. Not to be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid. Discontinue when used in combination w/ fenofibrate if cholelithiasis is suspected. Monitor INR if Lypstaplus is added to warfarin, another coumarin anticoagulant or fluindione. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Increased systemic exposure of rosuvastatin in Asian subjects including Japanese, Chinese, Malay & Indian ancestry. Dizziness may occur; may affect ability to drive or use machines. Not recommended in patients w/ moderate (Child Pugh score 7-9) or severe (Child Pugh score >9) liver dysfunction. Childn <18 yr. Elderly >65 yr (recommended start dose: rosuvastatin 5 mg); combination is not suitable for initial therapy.
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