EEXATOVAS 20

INDICATIONS:
Primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb): as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Primary dysbeta lipoproteinemia (type III hyperlipoproteinemia): Rosuvastatin is indicated as an adjunct to diet in the treatment of patients with primary dysbeta lipoproteinemia (type III hyperlipoproteinemia).
Rosuvastatin is indicated as an adjunct to diet in adult patients with hypertriglyceridemia.
Pediatric patients 7 to 17 years of age and adults with homozygous familial hypercholesterolemia: as an adjunct to diet and other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are not appropriate.
Pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH): As an adjunct to diet to reduce total-C, LDL-C, and ApoB in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia if the following persist after treatment with diet: LDL-C > 190 mg/dL or > 160 mg/dL and a family history of premature cardiovascular disease or two or more cardiovascular risk factors.
Rosuvastatin is indicated as adjunctive therapy to diet to slow the progression of atherosclerotic disease in adult patients as part of a treatment strategy to reduce total-C and LDL-C to target levels.
Primary prevention of cardiovascular disease: In individuals without clinical evidence of coronary heart disease but with an increased risk of cardiovascular disease, such as age ≥ 50 years in men, ≥ 60 years in women, hsCRP ≥ 2 mg/L, and at least 1 additional cardiovascular risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, rosuvastatin is indicated to:
Reduce the risk of stroke
Reduce the risk of myocardial infarction
Reduce the risk of coronary revascularization procedures.
Limitations of treatment: Rosuvastatin has not been studied in patients with Fredrickson type I and type V dyslipidemias.

DOSAGE AND ADMINISTRATION:

Administration:
Prior to initiation of treatment, the patient should be placed on a standard cholesterol-lowering diet and should continue on this diet throughout treatment. Use current Consensus Guidelines for the treatment of lipid disorders to adjust the dose of rosuvastatin for each patient according to the treatment goals and patient response.

Rosuvastatin can be taken at any time of the day, with or without food.

Dosage:
Treatment of hypercholesterolemia: The recommended starting dose is 5 mg or 10 mg, taken once daily in both statin-naive patients and patients transferred from another HMG-CoA reductase inhibitor to rosuvastatin. The selection of the starting dose should take into account the individual patient's cholesterol level, future cardiovascular risk, and the potential for adverse effects. Dose adjustments to the next dose may be made after 4 weeks if necessary. Because of the increased incidence of adverse reactions with the 40 mg dose compared with lower doses, a final titration to 40 mg should only be considered in patients with severe hypercholesterolemia at high cardiovascular risk (particularly those with familial hypercholesterolemia) who do not achieve their treatment goal on 20 mg and who require regular monitoring. Close specialist supervision is required when initiating 40 mg.

Prevention of cardiovascular events: In cardiovascular risk reduction studies, the dose was 20 mg daily.

Children:
Heterozygous familial hypercholesterolemia: The recommended dose range is 5-10 mg/day orally in patients 8 to <10 years of age, 5-20 mg/day in patients 10 to 17 years of age.
Homozygous familial hypercholesterolemia: The recommended dose is 20 mg/day orally in children aged 7 to 17 years.
Elderly: Treatment should be initiated at 5 mg once daily in patients over 70 years of age. No dosage adjustment is necessary due to age.
Renal impairment:
No dosage adjustment is necessary in patients with mild to moderate renal impairment. The recommended starting dose in patients with moderate renal impairment (creatinine clearance < 60 mL/min) is 5 mg. A dose of 40 mg is contraindicated in patients with moderate renal impairment.
Rosuvastatin is contraindicated in patients with severe renal impairment.
Patients with hepatic impairment: There was no increase in systemic exposure to rosuvastatin in patients with Child-Pugh scores ≤ 7. However, increased exposure was observed in patients with Child-Pugh scores 8 and 9. In these patients, assessment of renal function should be considered. There is no experience in patients with Child-Pugh scores above 9. Rosuvastatin is contraindicated in patients with active liver disease.
Asian patients: In Asian patients, consider starting with rosuvastatin 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider increased exposure in Asian patients when inadequately controlled with doses above 20 mg daily.
Use in combination therapy:
In combination with gemfibrozil: Start with rosuvastatin 5 mg once daily. The dose of rosuvastatin should not exceed 10 mg once daily.
In combination with atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir: Initiate rosuvastatin 5 mg once daily. The dose of rosuvastatin should not exceed 10 mg once daily.
In patients requiring 5 mg rosuvastatin, consider an alternative product.

CONTRAINDICATIONS:
Patients with hypersensitivity to rosuvastatin or to any of the excipients.
Patients with active liver disease including unexplained persistent elevations of serum transaminases, and when serum transaminase levels are greater than 3 times the upper limit of normal (ULN).
Patients with severe renal impairment (creatinine clearance < 30 mL/min).
Patients with myopathy.
Patients taking cyclosporine.
Pregnant and lactating women, women of childbearing potential not using adequate contraception.
The 40 mg dose is contraindicated in patients with risk factors for myopathy/rhabdomyolysis. These risk factors include:
Moderate renal impairment (creatinine clearance < 60 mL/min)
Hypothyroidism
Personal or family history of hereditary myopathy.
Previous history of muscle damage caused by another HMG-CoA reductase inhibitor or fibrate.