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LIPITOR®Highlights (atorvastatin calcium)

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.

LIPITOR® (atorvastatin calcium) tablets, for oral use
Initial U.S. Approval: 1996

RECENT MAJOR CHANGES

Warnings and Precautions, Myopathy and Rhabdomyolysis (5.1)11/2020
Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (5.2)9/2020

INDICATIONS AND USAGE

LIPITOR is an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to:

  • Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors (1.1).
  • Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors (1.1).
  • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD (1.1).
  • Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (1.2).
  • Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia (1.2).
  • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) (1.2).
  • 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 (1.2).

Limitations of Use:

LIPITOR has not been studied in Fredrickson Types I and V dyslipidemias (1.3).

DOSAGE AND ADMINISTRATION

  • Dose range: 10 to 80 mg once daily (2.1).
  • Recommended start dose: 10 or 20 mg once daily (2.1).
  • Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily (2.1).
  • Pediatric patients with HeFH: starting dose: 10 mg once daily; dose range: 10 to 20 mg/day for patients 10 years to 17 years of age (2.2).

DOSAGE FORMS AND STRENGTHS

Tablets: 10, 20, 40, and 80 mg of atorvastatin (3).

CONTRAINDICATIONS

  • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4).
  • Hypersensitivity to any component of this medication (4).
  • Pregnancy (4, 8.1, 8.3).
  • Lactation (4, 8.2).

WARNINGS AND PRECAUTIONS

  • Myopathy and Rhabdomyolysis: Risks increase when higher doses are used concomitantly with cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, human immunodeficiency virus (HIV) or hepatitis C virus (HCV) 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 unexplained and/or persistent muscle pain, tenderness, or weakness. LIPITOR therapy should be discontinued if myopathy is diagnosed or suspected (2.6, 5.1, 8.5).
  • Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents (5.2).
  • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter (5.3).
  • A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the previous 6 months in the LIPITOR 80 mg group vs. placebo (5.6).

ADVERSE REACTIONS

Most common 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 (6.1).


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. 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 that may Increase the Risk of Myopathy and Rhabdomyolysis with LIPITOR (2.6, 5.1, 7.1, 12.3)
Interacting AgentsPrescribing Recommendations
Cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvirAvoid atorvastatin
Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovirDo not exceed 20 mg atorvastatin daily
NelfinavirDo not exceed 40 mg atorvastatin daily
Lopinavir plus ritonavir, simeprevir, fibric acid derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, colchicineConsider the risk/benefit of concomitant use with atorvastatin
  • Other Lipid-Lowering Medications: Use 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 (7).
  • Rifampin should be simultaneously co-administered with LIPITOR (7.2).
  • Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased (7.3).
  • Digoxin: Patients should be monitored appropriately (7.3).

USE IN SPECIFIC POPULATIONS

  • Hepatic impairment: Plasma concentrations markedly increased in patients with chronic alcoholic liver disease (8.6, 12.3).
  • Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with LIPITOR (8.3).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2021

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