Important Safety Information
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Patient Support ProgramsPatient Support Programs
Helping you encourage at-risk patients with high cholesterol to treat their condition continues to be a priority for AstraZeneca. To assist you in helping your patients achieve their treatment goals, we’ve created a program for patients who are taking CRESTOR® (rosuvastatin calcium), as well as a Take Action Kit to help raise awareness of atherosclerosis.
CRESTOR 360°™ Patient Support Program
The CRESTOR 360° program was designed to encourage at-risk patients to overcome logistical and/or behavioral barriers to adherence. The program offers information — online and through the mail — that can be customized to fit each patient’s interests.
At-risk patients who enroll in the free program will receive
- Information about cholesterol and atherosclerosis
- Patient-selected content about topics such as diet, fitness, and managing stress as part of living a healthy lifestyle
- Optional weekly tip e-mails
- Links to Web sites and online tools
- Eligible patients may save on CRESTOR prescriptions with the CRESTOR Savings Card.* Patients can learn more about the card at www.crestor.com
To get your at-risk patients enrolled in the CRESTOR 360° program, simply ask your CRESTOR representative for CRESTOR 360° program Starter Kits. You can also enroll individual patients in the CRESTOR 360° program by visiting our consumer site.
*Certain restrictions apply.
Take Action Kit
As part of AstraZeneca’s initiative to raise understanding of atherosclerosis, we’ve created the Take Action Kit. The program aims to prepare at-risk patients to have a productive discussion about atherosclerosis during their next office visit. The Kit includes
- A series of informative brochures about atherosclerosis and risk factors patients may need to be concerned about
- Information about CRESTOR
- Questions to discuss during their office visit
- A 30-day free trial offer for CRESTOR
Let your patients know they can sign up to receive a Take Action Kit by visiting our consumer site.
At times, financial help is what patients need most. For those times, please consider these money-saving offers.
Important Safety Information for CRESTOR 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 mothers
- 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 with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, lopinavir/ritonavir, or atazanavir/ritonavir
- 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
- 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 postmarketing 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 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. 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
- 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 postmarketing 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
- The dose range for CRESTOR is 5 mg to 40 mg orally once daily. The usual starting dose is 10 mg to 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose. After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. CRESTOR 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 levels
- 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 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
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CRESTOR is licensed from SHIONOGI & CO, LTD, Osaka, Japan.
CRESTOR is a registered trademark, and CRESTOR 360˚ is a trademark of the AstraZeneca group of companies.
©2012 AstraZeneca. All rights reserved. 1569505 3
This product information is intended for US health care professionals only.
