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LIPITOR® (Atorvastatin Calcium) Tablets for Oral Administration Hypothyroidism, and Renal Impairment

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LIPITOR® (Atorvastatin Calcium) Tablets for Oral Administration Hypothyroidism, and Renal Impairment HIGHLIGHTS OF PRESCRIBING INFORMATION ----------------------WARNINGS AND PRECAUTIONS-----------------------­ These highlights do not include all the information needed to use Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase LIPITOR safely and effectively. See full prescribing information for when higher doses are used concomitantly with cyclosporine, fibrates, and LIPITOR. strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (> 65), uncontrolled LIPITOR® (atorvastatin calcium) Tablets for oral administration hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with Initial U.S. Approval: 1996 acute renal failure secondary to myoglobinuria have been reported. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued (5.1). ----------------------------INDICATIONS AND USAGE--------------------------- LIPITOR is an inhibitor of HMG-CoA reductase (statin) indicated as an Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic adjunct therapy to diet to: transaminases can occur. Monitor liver enzymes before and during treatment • Reduce the risk of MI, stroke, revascularization procedures, and angina (5.2). in patients without CHD, but with multiple risk factors (1.1). • Reduce the risk of MI and stroke in patients with type 2 diabetes without A higher incidence of hemorrhagic stroke was seen in patients without CHD CHD, but with multiple risk factors (1.1). but with stroke or TIA within the previous 6 months in the LIPITOR 80 mg • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, group vs. placebo (5.5). revascularization procedures, hospitalization for CHF, and angina in patients with CHD (1.1). ------------------------------ADVERSE REACTIONS------------------------------- • Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous The most commonly reported adverse reactions (incidence ≥ 2%) in patients familial and nonfamilial) and mixed dyslipidemia (1.2). treated with LIPITOR in placebo-controlled trials regardless of causality • Reduce elevated TG in patients with hypertriglyceridemia and primary were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract dysbetalipoproteinemia (1.2). infection (6.1). • Reduce total-C and LDL-C in patients with homozygous familial To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at hypercholesterolemia (HoFH) (1.2). (1-800-438-1985 and www.pfizer.com) or FDA at 1-800-FDA-1088 or • Reduce elevated total-C, LDL-C, and apo B levels in boys and www.fda.gov/medwatch. postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.2). ------------------------------DRUG INTERACTIONS------------------------------- Drug Interactions Associated with Increased Limitations of Use Risk of Myopathy/Rhabdomyolysis (2.6, 5.1, 7, 12.3) LIPITOR has not been studied in Fredrickson Types I and V dyslipidemias. Interacting Agents Prescribing Recommendations ----------------------DOSAGE AND ADMINISTRATION----------------------- Cyclosporine Do not exceed 10 mg atorvastatin Dose range: 10 to 80 mg once daily (2.1). daily Recommended start dose: 10 or 20 mg once daily (2.1). Clarithromycin, itraconazole, Patients requiring large LDL-C reduction (>45%) may start at 40 mg once HIV protease inhibitors (ritonavir Caution when exceeding doses > 20 daily (2.1). plus saquinavir or lopinavir plus mg atorvastatin daily. The lowest Pediatric starting dose: 10 mg once daily; maximum recommended dose: 20 ritonavir) dose necessary should be used. mg once daily (2.2). • Digoxin: Patients should be monitored appropriately (7.5). ---------------------DOSAGE FORMS AND STRENGTHS---------------------- • Oral Contraceptives: Values for norethindrone and ethinyl estradiol may 10, 20, 40, and 80 mg tablets (3). be increased (7.6). • Rifampin should be simultaneously co-administered with LIPITOR -------------------------------CONTRAINDICATIONS----------------------------- (7.4). Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4.1). -----------------------USE IN SPECIFIC POPULATIONS------------------------ Women who are pregnant or may become pregnant (4.3). • Hepatic impairment: Plasma concentrations markedly increased in Nursing mothers (4.4). patients with chronic alcoholic liver disease (12.3). Hypersensitivity to any component of this medication (4.2). See 17 for PATIENT COUNSELING INFORMATION Revised: [6/2009] _______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Prevention of Cardiovascular Disease 1.2 Hyperlipidemia 1.3 Limitations of Use 2 DOSAGE AND ADMINISTRATION 2.1 Hyperlipidemia 2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients 2.3 Homozygous Familial Hypercholesterolemia 2.4 Concomitant Lipid-Lowering Therapy 2.5 Dosage in Patients With Renal Impairment 2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or a Combination of Ritonavir plus Saquinavir or Lopinavir plus Ritonavir 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1 Active Liver Disease which may include Unexplained Persistent Elevations of Hepatic Transaminase Levels 4.2 Hypersensitivity to any Component of this Medication 4.3 Pregnancy 4.4 Nursing Mothers 5 WARNINGS AND PRECAUTIONS 5.1 Skeletal Muscle 5.2 Liver Dysfunction 5.3 Endocrine Function 5.4 CNS Toxicity 5.5 Use in Patients with Recent Stroke or TIA 6 ADVERSE REACTIONS 6.1 Clinical Trial Adverse Experiences 6.2 Postintroduction Reports 6.3 Pediatric Patients (ages 10-17 years) 7 DRUG INTERACTIONS 7.1 Strong Inhibitors of Cytochrome P450 3A4: Clarithromycin Combination of Protease Inhibitors Itraconazole 7.2 Grapefruit Juice 7.3 Cyclosporine 7.4 Rifampin or other Inducers of Cytochrome P450 3A4 7.5 Digoxin 7.6 Oral Contraceptives 7.7 Warfarin 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Prevention of Cardiovascular Disease 14.2 Hyperlipidemia and Mixed Dyslipidemia 14.3 Hypertriglyceridemia 14.4 Dysbetalipoproteinemia 14.5 Homozygous Familial Hypercholesterolemia 14.6 Heterozygous Familial Hypercholesterolemia in Pediatric Patients 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Muscle Pain 17.2 Liver Enzymes 17.3 Pregnancy 17.4 Breastfeeding *Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, LIPITOR can be started simultaneously with diet. 1.1 Prevention of Cardiovascular Disease In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, LIPITOR is indicated to: • Reduce the risk of myocardial infarction • Reduce the risk of stroke • Reduce the risk for revascularization procedures and angina In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to: • Reduce the risk of myocardial infarction • Reduce the risk of stroke In patients with clinically evident coronary heart disease, LIPITOR is indicated to: • Reduce the risk of non-fatal myocardial infarction • Reduce the risk of fatal and non-fatal stroke • Reduce the risk for revascularization procedures • Reduce the risk of hospitalization for CHF • Reduce the risk of angina 1.2 Hyperlipidemia LIPITOR is indicated: As an adjunct to diet to 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 (Fredrickson Types IIa and IIb); As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV); For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet; To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid- lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable; As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a. LDL-C
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