Label Changes for:
Crestor (rosuvastatin calcium) Tablets
February 2012
Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - January and November 2010, and February 2012
February 2012
WARNINGS AND PRECAUTIONS
Liver Enzyme Abnormalities
- It is recommended that liver enzyme tests be performed before the initiation of Crestor and if signs or symptoms of liver injury occur.
- There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. 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.
ADVERSE REACTIONS
Postmarketing Experience
- The following adverse reactions have been identified during postapproval use of Crestor: fatal and non-fatal hepatic failure
- There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
DRUG INTERACTIONS
Niacin
- 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. Fenofibrate
- 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.
PATIENT COUNSELING INFORMATION
Liver Enzymes
- It is recommended that liver enzymes 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.
PATIENT INFORMATION
What are the Possible Side Effects of Crestor?
Serious side effects may include:
- Liver problems: Your health care professional should do blood tests to check your liver before you start taking Crestor and if you have symptoms of liver problems while you take Crestor. Call your doctor right away if you have any of the following symptoms of liver problems: feel unusually tired or weak...
- The following additional side effects have been reported with Crestor: Memory loss and confusion
November 2010
ADVERSE REACTIONS
Postmarketing Experience
- Depression and sleep disorders (including insomnia and nightmares)
January 2010
WARNINGS AND PRECAUTIONS
Skeletal Muscle Effects
- 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).
DRUG INTERACTIONS
- Cyclosporine: Combination increases rosuvastatin exposure. Limit Crestor dose to 5 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases rosuvastatin exposure. Limit Crestor dose to 10 mg once daily
