Rosuvastatin

Visa No.: VD-23856-15

Product: Rostor 10

API: Rosuvastatin

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 277/QĐ-QLD_23/05/2022_175.1

INDICATIONS

Primary hypercholesterolemia (Type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (Type IIb):
Rosuvastatin is indicated as an adjunct to diet in patients who do not respond adequately to diet and other non-pharmacological measures (e.g., exercise, weight reduction)

Primary dysbetalipoproteinemia (Type III hyperlipoproteinemia): Rosuvastatin is indicated as adjunctive therapy to diet in patients with primary dysbetalipoproteinemia.
Rosuvastatin is indicated as adjunctive therapy to diet in adult patients with elevated triglycerides.

Homozygous familial hypercholesterolemia: Used as an adjunct to diet and other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not appropriate.

Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia (HeFH): Adjunct to diet to reduce total cholesterol, LDL-cholesterol, and ApoB levels in adolescents (females at least one year post-menarche) when, after adequate dietary therapy: LDL-C > 190 mg/dL or > 160 mg/dL with a family history of premature cardiovascular disease or at least two additional cardiovascular risk factors.
Rosuvastatin is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to achieve target total cholesterol and LDL-C levels. 

Primary Prevention of Cardiovascular Disease: 
In inpiduals without clinically evident coronary heart disease but at increased cardiovascular risk, such as: Men ≥50 years of age,   Women ≥60 years of age, hsCRP ≥2 mg/L, With at least one additional cardiovascular risk factor (e.g., hypertension, low HDL-C, smoking, or 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
Limitation of Use: Rosuvastatin has not been studied in patients with Fredrickson Type I and Type V dyslipidemia.
 

DOSAGE AND ADMINISTRATION

Before initiating treatment, patients should be placed on a standard cholesterol-lowering diet and should continue this diet throughout treatment. Current consensus guidelines for the management of dyslipidemia should be used to inpidualize the rosuvastatin dose according to treatment goals and patient response. 
Rosuvastatin may be taken at any time of the day, with or without food.

Treatment of Hypercholesterolemia: 
The recommended starting dose is 5 mg or 10 mg once daily for both statin-naïve patients and those switching from another HMG-CoA reductase inhibitor. The choice of initial dose should take into account the patient’s cholesterol level, future cardiovascular risk, and the potential risk of adverse reactions. Treatment should begin with the lowest effective dose, and if necessary, the dose may be adjusted based on inpidual response at intervals of no less than 4 weeks, with careful monitoring for adverse effects, particularly muscle-related effects.. Because the frequency of adverse reactions is higher with the 40 mg dose compared with lower doses, titration to 40 mg should only be considered in patients with severe hypercholesterolemia at high cardiovascular risk (especially those with familial hypercholesterolemia) who fail to achieve treatment goals at 20 mg, and these patients should be closely monitored. Specialist supervision is recommended when initiating the 40 mg dose.

Prevention of Cardiovascular Events: In studies evaluating reduction of cardiovascular events, the dose used was 20 mg once daily. 

Children: 
Heterozygous familial hypercholesterolemia in children 10–17 years of age: 
The usual dose range is 5–20 mg once daily. The maximum recommended dose is 20 mg/day (higher doses have not been studied in this population). Dose adjustments should be inpidualized according to treatment goals and made at intervals of at least 4 weeks.
Homozygous familial hypercholesterolemia: Experience is limited to a small number of children aged ≥8 years.

Elderly: In patients over 70 years of age, a starting dose of 5 mg once daily is recommended. No other dose adjustment is required based solely on age.

Patients with Renal Impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Rosuvastatin is contraindicated in patients with severe renal impairment.

Patients with Hepatic Impairment: No increase in systemic exposure to rosuvastatin has been observed in patients with Child-Pugh scores ≤7. However, increased exposure has been observed in patients with Child-Pugh scores of 8 and 9; assessment of renal function should be considered in these patients. There is no experience in patients with Child-Pugh scores >9. 
Rosuvastatin is contraindicated in patients with active liver disease.

Asian Patients
In Asian patients, consideration should be given to a starting dose of 5 mg once daily due to increased plasma concentrations of rosuvastatin. Increased systemic exposure should be taken into account when patients are not adequately controlled at doses above 20 mg/day.

Concomitant Use with Other Medicines
Combination with Gemfibrozil:
When co-administered, the starting dose of Rosuvastatin should be 5 mg once daily. The rosuvastatin dose should not exceed 10 mg once daily.
Combination with Atazanavir, Ritonavir and Lopinavir:
When rosuvastatin is used concomitantly with atazanavir, atazanavir/ritonavir, or lopinavir/ritonavir, the starting dose should be 5 mg once daily. The rosuvastatin dose should not exceed 10 mg once daily.

CONTRAINDICATIONS

• Hypersensitivity to Rosuvastatin or any component of the product.
• Active liver disease, including unexplained persistent elevations of serum transaminases and any serum transaminase level exceeding 3 times the upper limit of normal (ULN).
• Severe renal impairment (creatinine clearance <30 mL/min).
• Patients with myopathy.
• Concomitant use with Sofosbuvir/Velpatasvir/Voxilaprevir.
• Concomitant use with Ciclosporin.
• Pregnancy and breastfeeding, and women of childbearing potential not using appropriate contraception.

The 40 mg dose is contraindicated in patients with predisposing factors for myopathy/rhabdomyolysis. These factors include:
+ Moderate renal impairment (creatinine clearance <60 mL/min)
+ Hypothyroidism
+ Personal or family history of hereditary muscle disorders
+ Previous history of muscle toxicity with another HMG-CoA reductase inhibitor or fibrate
+ Alcohol abuse
+ Conditions that may increase plasma drug concentrations
+ Asian ethnicity
+ Concomitant use of fibrates
 

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.