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
|Dosage and Administration, Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, Letermovir, or Certain Protease Inhibitors (2.6)||11/2019|
|Warnings and Precautions, Skeletal Muscle (5.1)||11/2019|
|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).
- 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
- Skeletal muscle effects (e.g., 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).
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 (6.1).
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 Associated with Increased Risk of Myopathy/Rhabdomyolysis (2.6, 5.1, 7, 12.3)
|Interacting Agents||Prescribing Recommendations|
|Cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir, letermovir when co-administered with cyclosporine||Avoid atorvastatin|
|Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir||Do not exceed 20 mg atorvastatin daily|
|Nelfinavir||Do not exceed 40 mg atorvastatin daily|
|Lopinavir plus ritonavir, simeprevir, fibric acid derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, colchicine||Use with caution and lowest dose necessary|
- 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).
- Digoxin: Patients should be monitored appropriately (7.10).
- Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased (7.11).
- Rifampin should be simultaneously co-administered with LIPITOR (7.9).
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.