Safety

Crestor (rosuvastatin calcium) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

May 2016

Summary View

CONTRAINDICATIONS

  • Replace bullets 3 and 4 with the following:
  • Pregnancy
  • Lactation. Limited data indicate that CRESTOR is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require CRESTOR treatment should not breastfeed their infants.

ADVERSE REACTIONS

Clinical Studies Experience
  • In the CRESTOR controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were:
    • myalgia
    • abdominal pain
    • nausea
  • The most commonly reported adverse reactions (incidence ≥2%) in the CRESTOR controlled clinical trial database of 5394 patients were:
    • headache
    • myalgia
    • abdominal pain
    • asthenia
    • nausea
  • Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 1. These studies had a treatment duration of up to 12 weeks.

PATIENT COUNSELING INFORMATION

Embryofetal Toxicity (add new section)
  • Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy.
Lactation (add new section)
  • Advise women not to breastfeed during treatment with CRESTOR.

MEDICATION GUIDE

What is CRESTOR?

CRESTOR is used to treat:

  • adults who cannot control their cholesterol levels by diet and exercise alone
  • children 8 to 17 years of age with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL)
  • children 7 to 17 years of age with homozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL).

CRESTOR is not approved for use in children with heterozygous familial hypercholesterolemia younger than 8 years of age or for use in children with homozygous familial hypercholesterolemia younger than 7 years of age.
 

 

June 2015

Summary View

DRUG INTERACTIONS

  • Protease Inhibitors… Simeprevir, which is a hepatitis C virus (HCV) protease inhibitor, or combinations of atazanavir/ritonavir or lopinavir/ritonavir, which are HIV-1 protease inhibitors, increase rosuvastatin exposure (AUC) up to threefold.

 

July 2014

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse reactions have been identified… peripheral neuropathy 

 

August 2013

Summary View

WARNINGS AND PRECAUTIONS

Endocrine Effects
  • Based on clinical trial data with Crestor, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus…
 

ADVERSE REACTIONS

Clinical Studies Experience
Table 3 - Adverse Reactions* Reported in ≥ 2% of Patients Treated with Crestor and > Placebo in the
Jupiter Trial
  • Diabetes mellitus
Postmarketing Experience
  • thrombocytopenia

 

February 2012

Summary View

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

Summary View 

ADVERSE REACTIONS

Postmarketing Experience
  • Depression and sleep disorders (including insomnia and nightmares)

 

January 2010 

Summary View 

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

 

Page Last Updated: 06/10/2016
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