Dosing and Administration

CRESTOR® (rosuvastatin) is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, and 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.[1a]

CRESTOR is indicated to reduce the risk of myocardial infarction, stroke, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.[1b]

Start Dose Information

5 mg once daily

A round pale-yellow colour tablet imprinted with Z04522 5

  • 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
  • Concomitant use is not recommended with the combination of sofbuvir/velpatasvir/voxlaprevir or ledipasvir/sofosbuvir
  • In patients taking concomitant ticagrelor, especially those with additional risk factors for myopathy and rhabdomyolysis, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of CRESTOR
  • Administer CRESTOR at least 2 hours before aluminum and magnesium hydroxide combination antacids
  • Consider for patients taking atazanavir and ritonavir, lopinavir and ritonavir, simeprevir or combination of dasabuvir/ombitasvir/ paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir: the dose of CRESTOR should not exceed 10 mg once daily
  • Patients taking regorafenib, teriflunomide, enasidenib, or capmatinib: For concomitant use of CRESTOR and regorafenib or teriflunomide: the dose of CRESTOR should not exceed 10 mg once daily
  • For patients taking tafamidis: Avoid concomitant use with CRESTOR. If used concomitantly, initiate at 5 mg once daily and do not exceed 20 mg once daily
  • For patients taking cyclosporine and darolutamide: The dose of CRESTOR should not exceed 5 mg once daily
  • For patients taking fostamatinib and febuxostat: The dose of CRESTOR should not exceed 20 mg once daily
  • Asian patients, and patients with severe renal impairment not on hemodialysis

10 mg once daily

A round pink colour tablet imprinted with Z04022 10

Usual recommended start dose

20 mg once daily

A light pink round tablet imprinted with Z04522 20

Usual recommended start dose

Titration Dose

40 mg once daily

A light pink oval tablet imprinted with 40

Reserve only for patients not achieving LDL-C goal with 20 mg

(Tablets shown are not actual size)

  • In patients taking cyclosporine and darolutamide, the dose of CRESTOR should not exceed 5 mg once daily[1c]
  • In patients taking a combination of atazanavir and ritonavir, lopinavir and ritonavir, simeprevir or combination of dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir, initiate CRESTOR therapy with 5 mg once daily. The dose of CRESTOR should not exceed 10 mg once daily[1d]
  • For patients taking regorafenib, teriflunomide, enasidenib, or capmatinib, the dose of CRESTOR should not exceed 10 mg once daily
  • For patients taking fostamatinib and febuxostat, the dose of CRESTOR should not exceed 20 mg once daily
  • For patients taking tafamidis, avoid concomitant use with CRESTOR. If used concomitantly, initiate at 5 mg once daily and do not exceed 20 mg once daily
  • Combination therapy with CRESTOR and gemfibrozil should be avoided. If used together, initiate at 5 mg once daily and do not exceed CRESTOR 10 mg once daily[1e]
  • Concomitant use is not recommended with the combination of sofbuvir/velpatasvir/voxlaprevir or ledipasvir/sofosbuvir
  • 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[1f]
  • When initiating CRESTOR therapy or switching from another statin, the appropriate CRESTOR starting dose should first be used and only then titrated according to the patient's response and individualized goal of therapy[1g]
  • After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly[1h]

In patients with hyperlipidemia,

Significant LDL-C reductions at each dose[*], [1i]

  • 5 mg

    45%[†a]

    Reductions (n=17)

  • 10 mg

    52%[†b]

    Reductions (n=17)

  • 20 mg

    55%[†c]

    Reductions (n=17)

  • 40 mg

    63%[†d]

    Reductions (n=18)

  • * ^ A multicenter, double-blind, placebo-controlled, dose-ranging study in patients with hyperlipidemia given CRESTOR as a single daily dose for 6 weeks.
  • †a †b †c †d P<.001 vs -7% with placebo (n=13).

CRESTOR 40 mg should only be used for those patients not achieving their LDL-C goal with 20 mg.

Next: Pharmacokinetics

SAVINGS ELIGIBILITY

Eligible patients MAY pay as low as $3 for a 30-, 60-, or 90-day supply.[*]

* ^ Subject to eligibility. Restrictions apply.

Learn About Savings Eligibility

HELP YOUR PATIENTS REACH LDL-C GOAL WITH CRESTOR

In the STELLAR trial, in patients with hyperlipidemia or mixed dyslipidemia, nearly 9 out of 10 met their LDL-C goal with CRESTOR 20 mg.

Learn about patients reaching LDL-C goal

Important Safety Information for CRESTOR® (rosuvastatin) Tablets

  • CRESTOR is contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels or a known hypersensitivity to any component of this product
  • Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with statins, 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 (eg, age ≥65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased in Asian patients and with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), cyclosporine, teriflunomide, enasidenib, capmatinib, fostamatinib, febuxostat, gemfibrozil, tafamidis, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of sofosbuvir/velpatasvir/voxilaprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, all combinations with ledipasvir (including ledipasvir/sofosbuvir), colchicine or ticagrelor
  • Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing CRESTOR
  • There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Treatment with immunosuppressive agents may be required. Discontinue CRESTOR if IMNM is suspected
  • Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue CRESTOR
  • CRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease
  • CRESTOR significantly increased INR in patients receiving coumarin anticoagulants (eg, warfarin). In patients taking coumarin anticoagulants and CRESTOR concomitantly, INR should be determined before starting CRESTOR and frequently enough during early therapy to ensure that no significant alteration of INR occurs
  • Dipstick-positive proteinuria and microscopic hematuria were observed among patients treated with CRESTOR. These findings were more frequent in patients taking CRESTOR 40 mg, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, dose reduction should be considered for patients on CRESTOR therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing
  • Increases in HbA1c and fasting serum glucose levels have been reported with statins, including CRESTOR. Based on clinical trial data with CRESTOR, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus
  • In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%)
  • Rare post-marketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) have been associated with statin use, including CRESTOR. These reports are generally nonserious and reversible upon statin discontinuation
  • Discontinue CRESTOR when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient
  • CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg
  • Administer CRESTOR at least 2 hours before aluminum and magnesium hydroxide combination antacids

INDICATIONS

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor
  • Adjunct to diet to:
    • reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia
    • reduce LDL-C and slow the progression of atherosclerosis in adults
    • reduce LDL-C in patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)
  • Adjunct to other LDL-C lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)
  • Adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia or hypertriglyceridemia

Read full Prescribing Information.

You may report side effects related to AstraZeneca products.

References:

1a 1b 1c 1d 1e 1f 1g 1h 1i CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

  • 1a 1b 1c 1c 1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
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  • ^ Lipitor® (atorvastatin) [package insert]. New York, New York: Pfizer, 2021
  • ^ Livalo® (pitavastatin) [package insert]. Montgomery, AL: Kowa group of companies, 2020.
  • ^ Zocor® (simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022
  • ^ Vytorin® (ezetimibe/simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022.
  • ^ Lexcol® (fluvastatin sodium) [package insert]. East Hanover, New Jersey: Novartis; 2020
  • ^ Mevacor® (lovastatin) [package insert]. Whitehouse Station, New Jersey: Merck & Company, Inc. 2012
  • ^ Pravachol® (pravastatin) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company, 2020.
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  • ^ Zocor® (simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022
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  • ^ Faergeman O, Hill L, Windler E, et al; ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia: results from the ECLIPSE study. Cardiology. 2008;111(4):219-228.
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1a 1b 1c 1d 1e 1f 1g 1h 1i 1j 1k 1l 1m 1n 1o 1p 1q 1r CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

1a 1b 1c 1d1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

  • 1a CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • 2a Lipitor® (atorvastatin calcium) [prescribing information]. Morgantown, WV: Viatris Specialty LLC, 2024.
  • 3a Faergeman O, Hill L, Windler E, et al; on behalf of the ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Cardiology. 2008;111(4):219-228.
  • 4a Jones PH, Davidson MH, Stein EA, et al; for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152-160.
  • 5a Crouse JR 3rd, Raichlen JS, Riley WA, et al; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007;297(12):1344-1353.

Lipitor is a registered trademark of Upjohn Manufacturing Ireland Unlimited Company, a Viatris Company.

1a 1b 1c 1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

This product information is intended for US Health Care Professionals only.

IMPORTANT SAFETY INFORMATION FOR CRESTOR® (ROSUVASTATIN) TABLETS

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