IMPORTANT SAFETY INFORMATION AND INDICATIONS
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, and 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.
LIPITOR may cause myopathy and rhabdomyolysis with or without acute renal failure secondary to myoglobinuria. Rare fatalities have occurred as a result of rhabdomyolysis with statin use, including LIPITOR. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. LIPITOR should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. LIPITOR should be temporarily discontinued in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.
The concomitant use of higher doses of LIPITOR tablets with certain drugs such as cyclosporine, letermovir, strong CYP3A4 inhibitors and/or transport inhibitors (eg, clarithromycin, itraconazole, human immunodeficiency virus (HIV) or hepatitis C virus (HCV) protease inhibitors), and gemfibrozil may increase the risk of myopathy/ rhabdomyolysis. Lower doses of LIPITOR should be considered and, in some cases, avoided. Large quantities of grapefruit juice is not recommended. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing LIPITOR dosage.
There have been rare reports of immune-mediated necrotizing myopathy (IMNM) with statin use. Treatment with immunosuppressive agents may be required. Consider the risk of IMNM prior to initiation of a different statin.
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 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 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 tablets in placebo-controlled trials were nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.
LIPITOR 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); reduce the risk of MI and stroke in adult patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; 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 increase HDL-C in patients with primary hyperlipidemia (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).