Patient Web Site | Site Map | Contact Us

Safety profile

Safety profile in line with other leading statins

• Safety profile in line with other leading statins demonstrated by preapproval clinical trials in 10,275 patients and postmarketing experience^1,6,17

Supported by 2 completed studies of real-world use by nearly 100,000 patients*

• There was no evidence of a difference between patients on CRESTOR and patients on other statins in the incidence of hospitalizations associated with rhabdomyolysis, myopathy, renal dysfunction, or hepatic dysfunction in actual clinical practice^19,20
• Part of an ongoing 9-study pharmacoepidemiologic program

^* CRESTOR (n=21,396), other statins (n=74,678).

Long-term treatment and renal function from pooled data

• Glomerular filtration rate increases were seen after median of 8 weeks of treatment with CRESTOR 5 mg to 40 mg — and following long-term treatment^†21
• Mean serum creatinine levels decreased with all doses of CRESTOR over long-term treatment^†22
• CRESTOR was not associated with worsening of renal function — even among patients with preexisting kidney disease²¹

^† CRESTOR 5 mg (n=263), 10 mg (n=893), 20 mg (n=119), 40 mg (n=109) for ≥96 weeks.

CRESTOR is indicated

¹
As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non–HDL-C, and triglyceride levels and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

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.

CRESTOR is contraindicated

¹
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 or may become pregnant, and in nursing mothers.

Important safety information about CRESTOR

¹
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 (eg, age ≥ 65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/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 function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (eg, semiannually) thereafter. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended.

CRESTOR 40 mg should only be used for those patients not achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose.

Patients with severe renal impairment (CL_cr <30 mL/min/1.73 m²) not on hemodialysis have demonstrated a 3-fold increase in plasma concentrations and should be started at 5 mg once daily and not exceed 10 mg once daily.

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%).^1,13

The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined; long-term outcome studies are currently under way.

Please see full Prescribing Information for CRESTOR.

CRESTOR was licensed from SHIONOGI & CO. LTD, Osaka, Japan.