CRESTOR® (rosuvastatin calcium)

Time 2022-08-18 13:17:57

Web Name: CRESTOR® (rosuvastatin calcium)

WebSite: http://www.crestorhcp.com

ID:285579

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CRESTOR,rosuvastatin,calcium

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Prescribing CRESTOR

Important Safety Information Approved Uses Prescribing Information About CRESTORSafety and TolerabilityDosing and AdministrationPharmacokineticsClinical ExperienceLDL-C Goal Attainment and LDL-C ReductionsSlowing Atherosclerosis ProgressionAdditional Clinical DataPatient Savings Card

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As an adjunct to diet for your adult patients with hyperlipidemia

Address plaque head-on CRESTOR is indicated to slow the progression of atherosclerosis at any stage of the disease1

Lipitor® is not indicated to slow the progression of atherosclerosis2

CRESTOR is indicated as an adjunct 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.1

For illustration only: Represents potential long-term plaque buildup in the artery.

View 2-year study results 1 2 1 Prev Next

Are your hyperlipidemic patients at increased risk at goal?

In high-risk patients in the ECLIPSE trial, CRESTOR helped more patients achieve LDL-C goal than Lipitor®3

Hypothetical patient profiles.

View study description

CRESTOR 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.1

View head-to-head data 3 1Prev Next

In the STELLAR trial in patients with hyperlipidemia nearly 9 out of 10 patients met their LDL-C goal with CRESTOR 20 mg*,†,4

*Percentage of patients on CRESTOR 20 mg (n=160) achieving NCEP ATP III LDL-C goal by risk category5: High-risk–77.3%; Medium-risk–93.8%; Low-risk–94.0%. Mean baseline LDL-C: 187 mg/dL.

CRESTOR 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.1 1

View study description Explore the dataPrev Next

Study Description X

Adapted from the ECLIPSE trial.3 ECLIPSE was a 24-week, open-label, randomized, multicenter, forced-titration, parallel-group trial comparing the efficacy and safety of CRESTOR and atorvastatin in 1036 patients with hypercholesterolemia and CHD, 10-year CHD risk score >20% (CHD risk equivalent), or clinical evidence of atherosclerosis. Following a 6-week dietary lead-in period, patients were randomized to receive CRESTOR 10 mg or atorvastatin 10 mg for 6 weeks. Doses were force-titrated at 6-week intervals until maximum doses were achieved. Statistical comparisons were not made across the dose range, only across the same time period. The primary end point was percentage of patients achieving NCEP ATP III LDL-C goal of <100 mg/dL at Week 24.

Study Description X

Adapted from the STELLAR trial.4 STELLAR was a 6-week, multicenter, open-label, randomized, 15-arm trial comparing the efficacy and safety of CRESTOR with atorvastatin, simvastatin, and pravastatin in 2240 patients with hyperlipidemia or mixed dyslipidemia. The primary end point was percentage change from baseline in LDL-C at Week 6. Secondary end points included achievement of NCEP ATP III goal.

Help your eligible patients stay with CRESTOR! Select Dispense as Written [DAW] on your patient's prescription to help them keep the brand name.

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Eligible patients can pay as low as $3‡ for each prescription of CRESTOR‡

‡Subject to eligibility. Restrictions apply.Click here for eligibility information.

Learn more > 1976103-3214100 Last Updated 2/16

Important Safety Information for CRESTOR® (rosuvastatin calcium) Tablets

CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothersCases 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 with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, 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) or colchicineTherapy 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 CRESTORThere 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. Consider risk of recurrent IMNM carefully prior to initiation of a different statin, and monitor for signs and symptoms of IMNM if a different statin is reinitiated.It is recommended that liver enzyme tests be performed before the initiation of CRESTOR and if signs or symptoms of liver injury occur. All patients treated with CRESTOR should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. There have been rare post-marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including CRESTOR. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with CRESTOR, promptly interrupt therapy. If an alternate etiology is not found, do not restart CRESTORCRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver diseaseCRESTOR significantly increased INR in patients receiving coumarin anticoagulants. 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 occursDipstick-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 testingIncreases 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 mellitusIn 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%)1,2Rare 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 discontinuationCRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg

Indications

CRESTOR 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 levelsCRESTOR 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 the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease

Read full Prescribing Information (PDF - 152k)

References:

Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington,DE.Data on File, 268255. AstraZeneca Pharmaceuticals LP.

Lipitor is a registered trademark of Pfizer Inc.

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

CRESTOR is licensed from SHIONOGI & CO, LTD, Osaka, Japan. CRESTOR is a registered trademark of the AstraZeneca group of companies.

©2018 AstraZeneca. All rights reserved. 1976103-3214100 Last Updated 2/16

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