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Crestor

COMPOSITION

Each tablet contains 5 mg, 10mg or 20mg of rosuvastatin as rosuvastatin calcium.

PHARMACEUTICAL FORM

Film-coated tablet. Round, yellow coloured (5mg); Round, pink coloured (10mg and 20mg).

THERAPEUTIC INDICATIONS

CRESTOR (rosuvastatin calcium) is indicated as an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of elevated total cholesterol, LDL-cholesterol, ApoB, the total cholesterol: HDL-cholesterol ratio and triglycerides and for increasing HDL-C, in hyperlipidemic and dyslipidemic conditions, when response to diet and exercise alone has been inadequate including :

Primary hypercholesterolaemia (Type IIa including heterozygous familial hypercholesterolaemia and severe non-familial hypercholesterolaemia)

Combined (mixed) dyslipidemia (Type IIb)

Homozygous familial hypercholesterolaemia where CRESTOR is used either alone or as an adjunct to diet and other lipid lowering treatment such as apheresis.

CRESTOR is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.

POSOLOGY AND METHOD OF ADMINISTRATION

Patients should be placed on a standard cholesterol-lowering diet (at least equivalent to the Adult Treatment Panel III (ATP III TLC diet)) before receiving CRESTOR (rosuvastatin calcium), and should continue on this diet during treatment with CRESTOR. If appropriate, a program of weight control and physical exercise should be implemented.

Prior to initiating therapy with CRESTOR, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed.

The usual recommended starting dose of CRESTOR is 10 mg once daily. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions. The choice of starting dose should take into account the individual patients' cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. CRESTOR may be taken in the morning or evening, with or without food. The majority of patients are controlled at the 10mg dose. However, if necessary, dose adjustments to the next dose level can be made after 4-week intervals. The maximum response is usually achieved within 2-4 weeks and is maintained during chronic therapy. Increasing the dose to 40 mg should be reserved for patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg and should only be initiated under specialist supervision (see Special Warnings and Precautions for Use). The physician who elects to use CRESTOR at a dose higher than 20 mg should periodically re-evaluate the long term risk/benefit of CRESTOR for the individual patient. CRESTOR should be prescribed with caution in patients with pre-disposing factors for myopathy / rhabdomyolysis (see Special Warnings and Precautions for Use).

The dosage of CRESTOR should be individualised according to baseline LDL-C, total-C/HDL-C ratio and/or TG levels, the recommended target lipid values (see Recommendations for the Management and Treatment of Dyslipidemia [Canada] summarised below in Table 1) and/or the Third Report of the U.S. National Cholesterol Education Program [NCEP Adult Treatment Panel III]) and the patient response. The majority (80%) of patients treated with rosuvastatin 10 mg achieved their NCEP ATP III treatment target for LDL-C levels; fewer subjects (68%) achieved target on the 5 mg dose. The difference between rosuvastatin 5 mg and 10 mg was greatest for high risk subjects (40 versus 61%, respectively), i.e. for subjects who have a lower LDL-C target.

Lipid levels should be monitored periodically and, if necessary, the dose of CRESTOR adjusted based on target lipid levels recommended by guidelines.

Table 1: Canadian Recommendations for Target Lipid Values Based on Level of Risk

* Start medication and lifestyle changes concomitantly if values are above target values

** Start medication if target values are not achieved after 3 months of lifestyle modification

*** Start medication if target values are not achieved after 6 months of lifestyle modification

The following reductions in total cholesterol, LDL-C, TG, Total-C/HDL and increases in HDL-C have been observed in a dose-response study, and may serve as a guide to treatment of patients with mild to moderate hypercholesterolaemia:

Table 2: Dose-Response in Patients with Mild to Moderate Hypercholesterolaemia (Mean Percent change from Baseline)

Dosage in patients with renal insufficiency

The usual dose range applies in patients with mild to moderate renal impairment.

The use of CRESTOR in patients with severe renal impairment is contraindicated.

Dosage in patients with hepatic insufficiency

There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below. However, increased systemic exposure has been observed in subjects with Child-Pugh scores of 8 and 9. In these patients an assessment of renal function should be considered. There is no experience in subjects with Child-Pugh scores above 9. CRESTOR is contraindicated in patients with active liver disease.

Use in the elderly

Of the 10,275 patients in clinical studies with rosuvastatin, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. The overall frequency of adverse events and types of adverse events were similar in patients above and below 65 years of age. The efficacy of rosuvastatin in the geriatric population (≥ 65 years of age) was comparable to the efficacy observed in the non-elderly.

Use in children

The safety and effectiveness in children have not been established. Treatment experience with rosuvastatin in a children population is limited to 8 patients with homozygous FH. None of these patients was below 8 years of age.

Dosage on Asian Patients

Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients. The potential for increased systemic exposures relative to Caucasians is relevant when considering escalation of dose in cases where hypercholesterolaemia is not adequately controlled at doses of 5, 10 or 20 mg once daily (see Special warnings and special precautions for use and Pharmacokinetic properties).

Concomitant therapy

The effect of CRESTOR on LDL-C and total-C may be enhanced when used in combination with a bile acid binding resin. If CRESTOR is used in combination with gemfibrozil, the dose of CRESTOR should be limited to 10mg once daily.

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