LIPITOR safety information
IMPORTANT SAFETY INFORMATION

LIPITOR® (atorvastatin calcium) tablets are contraindicated in patients with a known hypersensitivity to any component of this product; in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are breastfeeding. 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.

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LIPITOR® (atorvastatin calcium) tablets and other statins. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.

The concomitant use of higher doses of LIPITOR® (atorvastatin calcium) tablets with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Lower doses of LIPITOR should be considered. Physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating the dose of either drug.

It is recommended that liver function tests be performed prior to the initiation of therapy and repeated as clinically indicated thereafter.

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR® (atorvastatin calcium) tablets.

In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the LIPITOR® 80 mg (atorvastatin calcium) tablets group compared with placebo (2.3% vs 1.4%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the LIPITOR group.

The most commonly reported adverse reactions with LIPITOR® (atorvastatin calcium) tablets in placebo-controlled trials were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.

INDICATIONS

LIPITOR® (atorvastatin calcium) tablets are indicated as an adjunct to diet to:

  • Reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients with multiple risk factors but without clinically evident coronary heart disease (CHD); to reduce the risk of MI and stroke in adult patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adult patients with clinically evident CHD

  • Reduce elevated total-C, LDL-C, apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia

  • Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia

  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH)

  • Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy

Limitations of Use: LIPITOR has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Please see Full Prescribing Information and Patient Information.

Safety

Highlights of Prescribing Information

These highlights do not include all the information needed to use LIPITOR safely and effectively. See Full Prescribing Information for LIPITOR.

Contraindications

  • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels.
  • Women who are pregnant or may become pregnant.
  • Nursing mothers.
  • Hypersensitivity to any component of this medication.

Warnings and Precautions

Skeletal muscle effects (eg, myopathy and rhabdomyolysis): Risks increase when higher doses are used concomitantly with cyclosporine and strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician any unexplained and/or persistent muscle pain, tenderness, or weakness. LIPITOR therapy should be discontinued if myopathy is diagnosed or suspected.

Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.

A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the 6 months previous to therapy in the LIPITOR 80 mg group versus placebo.

Adverse Reactions

The most commonly reported adverse reactions (incidence ≥2%) in patients treated with LIPITOR in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 and www.pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Drug Interactions Associated With Increased Risk of Myopathy/Rhabdomyolysis

Drug interactions associated with increased risk of myopathy/rhabdomyolysis
  • Other Lipid-Lowering Medications: Use of LIPITOR with fibrate products or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with LIPITOR.
  • Digoxin: Patients should be monitored appropriately.
  • Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased.
  • Rifampin should be simultaneously co-administered with LIPITOR.