Fenofibrate

Brand names: ANTARA, Antara, Fenofibric Acid, Fenofibric acid, Fenoglide, LIPOFEN, Lofibra, TRICOR, TRIGLIDE, Tricor, Triglide, Fenofibrate, FENOFIBRATE, fenofibrate, Lipofen

Warnings

No boxed warning. Contraindicated in "severe renal impairment, including those with end-stage renal disease," "active liver disease," "pre-existing gallbladder disease," and known hypersensitivity to fenofibrate or fenofibric acid. Major warnings include risk of "serious drug-induced liver injury, including liver transplantation and death"; "myopathy and rhabdomyolysis," particularly with concomitant statin use or renal impairment; increased serum creatinine; cholelithiasis; pancreatitis; venous thromboembolism; and potentiated anticoagulant effect with coumarin-type drugs requiring dose adjustment and monitoring.

Contraindications

4 CONTRAINDICATIONS Fenofibrate is contraindicated in patients with: • Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology ( 12.3 )] . • Active liver disease, including those with unexplained persistent liver function abnormalities [see Warnings and Precautions ( 5.2 )] . • Pre-existing gallbladder disease [see Warnings and Precautions ( 5.5 )] . • Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate tablets. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate [see Warnings and Precautions ( 5.9 )] . • Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis ( 4 ). • Active liver disease including those with unexplained persistent liver function abnormalities ( 4 ). • Pre-existing gallbladder disease ( 4 ). • Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate ( 4 ).

Overdose

10 OVERDOSAGE In the event of an overdose of fenofibrate, consider contacting the Poison Help line (1-800- 222-1222) or a medical toxicologist for additional overdosage management recommendations. There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.

Drug interactions

7 DRUG INTERACTIONS Table 2 presents clinically important drug interactions with Fenofibrate. Table 2: Clinically Important Drug Interactions with Fenofibrate Statins Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins. Intervention: Consider if the benefit of using fenofibrate concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of statin therapy. Colchicine Clinical Impact : Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fenofibrates. Intervention: Consider if the benefit of using colchicine concomitantly with fenofibrate outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of colchicine. Coumarin Anticoagulants Clinical Impact : Fibrates may cause potentiation of coumarin-type anticoagulant effects with prolongation of the PT/INR. Intervention: Caution should be exercised when coumarin anticoagulants are given in conjunction with fenofibrate. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized Immunosuppressants Clinical Impact : Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibrate, there is a risk that an interaction will lead to deterioration of renal function. Intervention: The benefits and risks of using fenofibrate with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dosage employed and renal function monitored. Bile-Acid Binding Resins Clinical Impact : Bile-acid binding resins may bind other drugs given concurrently. Intervention: In patients taking a bile acid resin, administer fenofibrate at least 1 hour before or 4 to 6 hours after the bile acid resin to avoid impeding its absorption. • Consider if the benefit of concomitant use of statins or colchicine outweighs the increased risk of myopathy and rhabdomyolysis. Monitor patients for signs and symptoms of myopathy ( 7 ). • Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the PT/INR at the desired level to prevent bleeding complications ( 7 ). • Consider the benefits and risks of concomitant use with immunosuppressants and other potentially nephrotoxic agents. Use the lowest effective dosage and monitor renal function ( 7 ). • Administer fenofibrate at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption ( 7 ).

Uses

Fenofibrate is indicated as adjunctive therapy to diet to reduce "triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL)" and to reduce elevated "low-density lipoprotein cholesterol (LDL-C)" in adults with primary hyperlipidemia when statin therapy is not appropriate. The label includes an important limitation of use: "Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus."

Dosage forms & strengths

Capsule Capsule, Delayed Release Tablet Tablet, Coated Tablet, Film Coated TABLET, FILM COATED TABLET CAPSULE POWDER TABLET, COATED

CHOLINE FENOFIBRATE 135 mg CHOLINE FENOFIBRATE 45 mg FENOFIBRATE 120 mg FENOFIBRATE 130 mg FENOFIBRATE 134 mg FENOFIBRATE 145 mg FENOFIBRATE 150 mg FENOFIBRATE 160 mg FENOFIBRATE 200 mg FENOFIBRATE 30 mg FENOFIBRATE 40 mg FENOFIBRATE 43 mg FENOFIBRATE 48 mg FENOFIBRATE 50 mg FENOFIBRATE 54 mg FENOFIBRATE 67 mg FENOFIBRATE 90 mg Fenofibrate 120 mg Fenofibrate 130 mg Fenofibrate 160 mg Fenofibrate 40 mg Fenofibrate 43 mg Fenofibrate 54 mg fenofibrate 120 mg fenofibrate 160 mg fenofibrate 40 mg FENOFIBRATE 160 mg/1 FENOFIBRATE 40 mg/1 FENOFIBRATE 54 mg/1 FENOFIBRATE 134 mg/1 FENOFIBRATE 200 mg/1 FENOFIBRATE 67 mg/1 FENOFIBRATE 145 mg/1 FENOFIBRATE 48 mg/1 FENOFIBRATE 1 kg/kg FENOFIBRATE 25 kg/25kg FENOFIBRATE 43 mg/1 FENOFIBRATE 50 mg/1 FENOFIBRATE 130 mg/1 FENOFIBRATE 120 mg/1 FENOFIBRATE 90 mg/1 FENOFIBRATE 30 mg/1 FENOFIBRATE 150 mg/1

2 DOSAGE AND ADMINISTRATION • Severe hypertriglyceridemia: 48 to 145 mg orally once daily; the dosage should be adjusted according to patient response ( 2.2 ). • Primary hyperlipidemia:145 mg orally once daily ( 2.2 ). • Administer as a single dose, at any time of day, with or without food ( 2.2 ). • Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibrate. Discontinue fenofibrate in patients who do not have an adequate response after 2 months of treatment ( 2.2 ). • Renal impairment: Initial dosage of 48 mg orally once daily ( 2.3 ). • Geriatric patients: Select the dosage on the basis of renal function ( 2.4 ) 2.1 Prior to Initiation of Fenofibrate • Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high TG levels and manage as appropriate. • Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate, and should continue this diet during treatment with fenofibrate tablets. • In patients with diabetes and fasting chylomicronemia, improve glycemic control prior to considering starting fenofibrate tablets. 2.2 Recommended Dosage and Administration • Severe hypertriglyceridemia: o The recommended dosage of fenofibrate tablets is 48 mg or 145 mg orally once daily. o Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. • Primary hyperlipidemia: o The recommended dosage of fenofibrate tablets is 145 mg orally once daily. • Administer fenofibrate tablets as a single dose at any time of day, with or without food. • Advise patients to swallow fenofibrate tablets whole. Do not crush, break, dissolve, or chew tablets. • Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibrate tablets. Discontinue fenofibrate tablets in patients who do not have an adequate response after 2 months of treatment. • If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose. • Advise patients to take fenofibrate tablets at least 1 hour before or 4 hours to 6 hours after a bile acid binding resin to avoid impeding its absorption. 2.3 Recommended Dosage in Patients with Renal Impairment • Assess renal function prior to initiation of fenofibrate and periodically thereafter [see Warnings and Precautions ( 5.4 )] . • Treatment with fenofibrate tablets should be initiated at a dosage of 48 mg orally once daily in patients with mild to moderately impaired renal function (eGFR 30 to <60 mL/min/1.73m 2 ), and increased only after evaluation of the effects on renal function and TG levels at this dosage. • Fenofibrate tablets are contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73m 2 ), including those with end-stage renal disease (ESRD) and those receiving dialysis [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] . 2.4 Recommended Dosage in Geriatric Patients Dosage selection for geriatric patients should be made on the basis of renal function [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .

All identified pills

MYLAN 6088

ORANGE;PINK CAPSULE · Fenofibrate