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Lipofen® (Fenofibrate Capsules USP) for Oral Use 50 Mg and 150 Mg

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Lipofen® (Fenofibrate Capsules USP) for Oral Use 50 Mg and 150 Mg Lipofen® (fenofibrate capsules USP) for oral use 50 mg and 150 mg January 2013 This document contains the labeling text which may be accessed on the NIH DailyMed page http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9a883573-aa2a-4376-bb0f-3b88246d2169 LIP-RA-0020 Kowa Pharmaceuticals America, Inc. LIPOFEN (fenofibrate capsules, USP) Version of January 2013 HIGHLIGHTS OF PRESCRIBING INFORMATION WARNINGS AND PRECAUTIONS • Fibrates increase the risk of myopathy, and rhabdomyolysis has been These highlights do not include all the information needed to use reported in patients taking fibrates (with a significantly higher rate observed LIPOFEN® safely and effectively. See full prescribing information for with gemfibrozil); rhabdomyolysis risk is increased in the elderly, patients ® with diabetes, renal insufficiency or hypothyroidism (5.2) LIPOFEN . • Fenofibrate can increase serum transaminases. Monitor liver tests, including LIPOFEN® (fenofibrate capsules, USP) for oral use ALT, periodically during therapy (5.3) Initial U.S. Approval: 1993 • Fenofibrate can reversibly increase serum creatinine levels (5.4). Monitor renal function periodically in patients with renal impairment (8.6) INDICATIONS AND USAGE • Fenofibrate may increase cholesterol excretion into the bile, leading to LIPOFEN is a peroxisome proliferator receptor alpha (PPARα) activator cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated indicated as an adjunct to diet: (5.5) • To reduce elevated LDL-C, total-c, TG and Apo B, and to increase HDL-C • Exercise caution in concomitant treatment with coumarin-type in adult patients with primary hypercholesterolemia or mixed dyslipidemia anticoagulants. Adjust dosage of these anticoagulants to maintain the (1.1) Prothrombin Time/International Normalized Ratio (PT/INR) at the desired • To reduce triglycerides in adult patients with severe hypertriglyceridemia level to prevent bleeding complications (5.6 , 7.1) (1.2) ADVERSE REACTIONS Important Limitations of Use: The most common adverse reactions (incidence of > 2% and at least 1% • Fenofibrate at a dose equivalent to 150 mg of LIPOFEN was not shown greater than placebo) are abnormal liver tests, increased AST, increased ALT, to reduce coronary heart disease morbidity and mortality in a large, increased CPK, and rhinitis (6). randomized controlled trial of patients with type 2 diabetes mellitus (5.1) To report SUSPECTED ADVERSE REACTIONS, contact Kowa Pharmaceuticals America, Inc. at 1 (877) 334-3464 or FDA at 1-800- DOSAGE AND ADMINISTRATION FDA-1088 or via the web at www.fda.gov/medwatch/index.html for • Primary hypercholesterolemia or mixed dyslipidemia: 150 mg per day (2.2) voluntary reporting of adverse reactions. • Severe Hypertriglyceridemia: 50 to 150 mg per day; adjust the dose according to patient response (2.3) To report SUSPECTED ADVERSE REACTIONS, contact at or FDA at • Renally impaired patients: 50 mg per day; increase the dose according to 1-800-FDA-1088 or www.fda.gov/medwatch the effect on renal function and lipid levels (2.4) • Geriatric patients: select the dose based on renal function (2.5) DRUG INTERACTIONS • The maximum daily dose is 150 mg per day (2.3) • Coumarin-type anticoagulants (7.1) • Immunosuppressants (7.2) DOSAGE FORMS AND STRENGTHS • Bile acid binding resins (7.3) • Oral capsules: 50 mg and 150 mg (3) • Colchicine (7.4) CONTRAINDICATIONS USE IN SPECIFIC POPULATIONS • Severe renal impairment, including patients receiving dialysis (4, 8.6, 12.3) • Geriatric Use: Determine dose selection based on renal function (8.5) • Active liver disease (4, 12.3) • Renal Impairment: Avoid use in patients with severe renal impairment. • Gallbladder disease (4, 5.5) Dose reduction is required in patients with mild to moderate renal • Known hypersensitivity to fenofibrate or fenofibric acid (4, 5.9) impairment (8.6, 12.3) • Nursing Mothers (4,8.3) See 17 for PATIENT COUNSELING INFORMATION Revised: 01/2013 LIP-RA-0020 Kowa Pharmaceuticals America, Inc. LIPOFEN (fenofibrate capsules, USP) Version of January 2013 FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS 1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia 7.1 Coumarin Anticoagulants 1.2 Severe Hypertriglyceridemia 7.2 Immunosuppressants 1.3 Important Limitations of Use 7.3 Bile-Acid Binding Resins 2 DOSAGE AND ADMINISTRATION 7.4 Colchicine 2.1 General Considerations 8 USE IN SPECIFIC POPULATIONS 2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia: 8.1 Pregnancy 2.3 Severe Hypertriglyceridemia: 8.3 Nursing Mothers 2.4 Impaired Renal Function 8.4 Pediatric Use 2.5 Geriatric Patients 8.5 Geriatric Use 3 DOSAGE FORMS AND STRENGTHS 8.6 Renal Impairment 4 CONTRAINDICATIONS 8.7 Hepatic Impairment 5 WARNINGS AND PRECAUTIONS 10 OVERDOSAGE 5.1 Coronary Heart Disease Morbidity and Mortality 11 DESCRIPTION 5.2 Skeletal Muscle 12 CLINICAL PHARMACOLOGY 5.3 Liver Function 12.1 Mechanism of Action 5.4 Serum Creatinine 12.2 Pharmacodynamics 5.5 Cholelithiasis 12.3 Pharmacokinetics 5.6 Coumarin Anticoagulants 13 NON-CLINICAL TOXICOLOGY 5.7 Pancreatitis 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.8 Hematologic Changes 14 CLINICAL STUDIES 5.9 Hypersensitivity Reactions 14.1 Primary Hypercholesterolemia (Heterozygous Familial and 5.10 Venothromboembolic Disease Nonfamilial) and Mixed Dyslipidemia 5.11 Paradoxical Decreases in HDL Cholesterol Levels 14.2 Severe Hypertriglyceridemia 6 ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 6.1 Clinical Trials Experience 17 PATIENT COUNSELING INFORMATION 6.2 Postmarketing Experience * Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia LIPOFEN is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. 1.2 Severe Hypertriglyceridemia LIPOFEN is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. 1.3 Important Limitations of Use Fenofibrate at a dose equivalent to 150 mg of LIPOFEN was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions(5.1)]. 2 DOSAGE AND ADMINISTRATION 2.1 General Considerations LIPOFEN capsules should be given with meals thereby optimizing the absorption of the medication. Patients should be advised to swallow LIPOFEN capsules whole. Do not open, crush, dissolve or chew capsules. Patients should be placed on an appropriate lipid-lowering diet before receiving LIPOFEN, and should continue this diet during treatment with LIPOFEN. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. LIP-RA-0020 Kowa Pharmaceuticals America, Inc. page 2 of 13 LIPOFEN (fenofibrate capsules, USP) Version of January 2013 Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of LIPOFEN. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 150 mg per day. Consideration should be given to reducing the dosage of LIPOFEN if lipid levels fall significantly below the targeted range. 2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia: The dose of LIPOFEN is 150 mg once daily. 2.3 Severe Hypertriglyceridemia: The initial dose is 50 to 150 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determination at 4 to 8 week intervals. The maximum dose of LIPOFEN is 150 mg once daily. 2.4 Impaired Renal Function In patients with mild-to-moderate renal impairment, treatment with LIPOFEN should be initiated at a dose of 50 mg per day, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of LIPOFEN should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 2.5 Geriatric Patients Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5) and Clinical Pharmacology
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