Indicated for the treatment of:

Hyperlipidemia and Mixed Dyslipidemia: (Adults)

• As adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

Pediatric Patients with Familial Hypercholesterolemia: (Children and Adolescents 7-17 years of age)

• As an adjunct to diet to: reduce Total-C, LDL-C and ApoB levels in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C >190 mg/dL, or >160 mg/dL along with a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. 

• To reduce LDL-C, Total-C, nonHDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis).

Hypertriglyceridemia: (Adults)

• As adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia): (Adults)

• As an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).

Adult Patients with Homozygous Familial Hypercholesterolemia:

• As adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

Slowing of the Progression of Atherosclerosis: (Adults)

• 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.

Primary Prevention of Cardiovascular Disease: (Adults)

• 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, CRESTOR is indicated to

• reduce the risk of stroke
• reduce the risk of myocardial infarction
• reduce the risk of arterial revascularization procedures

CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias. 

In Asian patients, consider initiation of CRESTOR therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations.

For patients with severe renal impairment (CLcr <30 mL/min/1.73  m² ) not on hemodialysis, dosing of CRESTOR should be started at 5 mg once daily and not exceed 10 mg once daily.

CRESTOR is contraindicated in the following conditions:

• Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels 
• Pregnancy 
• Lactation

Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg).

CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age ≥65 years, inadequately treated hypothyroidism, renal impairment).

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.

CRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease.

There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin.

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including CRESTOR.

In patients taking cyclosporine and darolutamide dose of CRESTOR should not exceed 5 mg once daily.

Concomitant use of CRESTOR and regorafenib, the dose of CRESTOR should not exceed 10 mg once daily.

Avoid concomitant use of CRESTOR with gemfibrozil. If concomitant use cannot be avoided, initiate CRESTOR at 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily.

In patients taking atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily.

Caution should be exercised when anticoagulants are given in conjunction with CRESTOR because of its potentiation of the effect of coumarin-type anticoagulants in prolonging the prothrombin time/INR.

The risk of skeletal muscle effects may be enhanced when CRESTOR is used in combination with lipid-modifying doses (≥1 g/day) of niacin; caution should be used when prescribing with CRESTOR.

The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir.

Co-administration of rosuvastatin with certain protease inhibitors has differing effects on rosuvastatin exposure and may increase risk of myopathy. Simeprevir, which is a hepatitis C virus (HCV) protease inhibitor, or combinations of atazanavir/ritonavir or lopinavir/ritonavir, which are HIV-1 protease inhibitors, increase rosuvastatin exposure.

Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concomitant use of fenofibrates, caution should be used when prescribing fenofibrates with CRESTOR.

Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors, including rosuvastatin, coadministered with colchicine, and caution should be exercised when prescribing CRESTOR with colchicine.

CRESTOR is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with CRESTOR during pregnancy. CRESTOR may cause fetal harm when administered to pregnant women.

Rosuvastatin use is contraindicated during breastfeeding. Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with CRESTOR.

GoToSource

• Use in patients under the age of 7. GoToSource

• Use in pediatric patients 8-17 years of age for treatment other than heterozygous familial hypercholesterolemia. GoToSource

• Use in pediatric patients 7-17 years of age for treatment other than homozygous familial hypercholesterolemia. GoToSource

• Venous thromboembolism. GoToSource

• Prevention of stroke recurrence. GoToSource

• Prevention of contrast-induced nephropathy in patients undergoing primary percutaneous coronary intervention. GoToSource

• Prevention of ischemic stroke, rare congenital neurometabolic storage diseases, treatment of acute brain injury and chronic central nervous system inflammation. GoToSource

• Multiple sclerosis and rheumatoid arthritis. GoToSource

⚠️  Patients with SLCO1B1 gene results in higher systemic concentrations of this medication. 

Myopathy (disease of muscle tissue) and rhabdomyolysis (breakdown of muscle tissue). GoToSource

Kidney failure. GoToSource

New-onset diabetes. GoToSource

Proteinuria (large amounts of protein in urine). GoToSource

Increased risk of lung cancer in female patients. GoToSource

Severe bladder hypotonia. GoToSource

Pemphigoid (autoimmune blistering skin diseases). GoToSource

Ischaemic colitis. GoToSource

Bilateral quadriceps tendon rupture. GoToSource

Hepatitis (inflammation of the liver) and thrombocytopenia (low blood platelet count). GoToSource

Erectile dysfunction. GoToSource

Gynecomastia (enlarged male breast tissue). GoToSource

Liver toxicity. GoToSource

Memory loss and cognitive impairment. GoToSource

Myasthenia gravis. GoToSource

Pancreatitis. GoToSource

Lawsuits filed for rhabdomyolysis, kidney failure, liver failure, chronic bleeding and type 2 diabetes.