ROSUVASTATIN SANDOZ FILM COATED TABLET 20MG [SIN14953P]

Product Info

ROSUVASTATIN SANDOZ FILM COATED TABLET 20MG

[SIN14953P]

4.1 Therapeutic indications
Primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type IIa, IIb; and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate.

Primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate.

Reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. Rosuvastatin also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I.

Homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g., LDL apheresis).

Primary prevention of cardiovascular disease. Rosuvastatin is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease 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 arterial revascularization procedures

Indicated in children and adolescents 10 to 17 years of age as an adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year postmenarche, 10–17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Paediatric studies were conducted mainly in the non-Asian population and data on Asian children/adolescents is limited.

4.2 Posology and method of administration
The dosage of rosuvastatin should be individualized according to the goal of therapy and patient response. The recommended start dose is 5 or 10 mg once daily in both statin naïve patients or patients switched from another HMG CoA reductase inhibitor. The choice of starting dose should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. A dose adjustment to the next dose level can be made after 4–6 weeks, if necessary (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 close specialist supervision (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The physician who elects to use rosuvastatin at doses higher at doses higher than 20 mg should periodically re-evaluate the long-term risk/benefit of rosuvastatin for the individual patient. Rosuvastatin should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Rosuvastatin may be given at any time of day, with or without food.

Use in the elderly
No dose adjustment is necessary.

Dosage in patients with renal insufficiency
No dose adjustment is necessary in patients with mild to moderate renal impairment.
For patients with severe renal impairment the use of rosuvastatin is contraindicated (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage in patients with hepatic insufficiency
The usual dose range applies in patients with mild hepatic impairment [Child-Pugh scores ≤ 7 ]. Increased systemic exposure to rosuvastatin has been observed in patients with moderate hepatic impairment [Child-Pugh scores of 8 and 9]. There is no experience in patients with severe hepatic impairment. Rosuvastatin is contraindicated in patients with active liver disease (see section 4.3).

Use in Asian population
Increased plasma concentration of rosuvastatin has been seen in Asian subjects including subjects of Japanese, Chinese, Malay and Indian ancestry (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Increased systemic exposure, which is considered a pre-disposing factor for myopathy, should be taken into consideration when making dose decisions for Asian patients. Initiation of rosuvastatin therapy with 5 mg once daily should be considered for Asian patients. This should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. Doses exceeding 20 mg are not generally recommended and should only be considered for patients with high cardiovascular risk whose hypercholesterolaemia is not controlled with doses up to 20 mg. In rare cases where rosuvastatin at doses higher than 20 mg is indicated, initiation of therapy should be under close specialist supervision. The physician who elects to use rosuvastatin at doses higher than 20 mg should periodically re-evaluate the long-term risk/benefit of rosuvastatin for the individual patient.

Use in children
In paediatric patients with heterozygous familial hypercholesterolemia the recommended starting dose of rosuvastatin is 5 mg taken orally once daily. The rosuvastatin dose should be individualized according to baseline LDL-C levels and the recommended goal of therapy. The maximum daily dose in this patient population is 10 mg. Adjustments should be made at intervals of 4 weeks or more.
The safety and efficacy of rosuvastatin doses greater than 20 mg have not been studied in this population. Treatment experience in paediatric patients with heterozygous familial hypercholesterolaemia is limited to 52 weeks.

Genetic polymorphisms
Genotypes of SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA have been shown to be associated with an increase in rosuvastatin exposure (AUC) compared to SLCO1B1 c.521TT and ABCG2 c.421CC. For patients known to have the c.521CC or c.421AA genotype, a maximum once daily dose of 20 mg of rosuvastatin is recommended (see section 4.4, 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Concomitant therapy
Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when rosuvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir; see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rosuvastatin. Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Rosuvastatin therapy. In situations where co-administration of these medicinal products with Rosuvastatin is unavoidable, the benefit and the risk of concurrent treatment and Rosuvastatin dosing adjustments should be carefully considered (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
Rosuvastatin is contraindicated:

• in patients with hypersensitivity to any component of this product.

• in patients with active liver disease including unexplained, persistent elevations of serum transaminases.

• in patients with severe renal impairment (creatinine clearance <30 ml/min).

• in patients receiving concomitant ciclosporin.