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Fenofibrate and Derivatives

Pronunciation

Pronunciation

(fen oh FYE brate & dah RIV ah tives)

Index Terms

  • ABT-335
  • Choline Fenofibrate
  • Fenofibric Acid
  • Procetofene
  • Proctofene

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as fenofibrate:

Antara: 30 mg, 43 mg [DSC] [contains fd&c blue #2 (indigotine), fd&c yellow #10 (quinoline yellow)]

Antara: 90 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Antara: 130 mg [DSC] [contains fd&c blue #2 (indigotine), fd&c yellow #10 (quinoline yellow)]

Lipofen: 50 mg [contains brilliant blue fcf (fd&c blue #1), fd&c blue #2 (indigotine), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Lipofen: 150 mg

Lofibra: 67 mg, 134 mg, 200 mg

Generic: 43 mg, 50 mg, 67 mg, 130 mg, 134 mg, 150 mg, 200 mg

Capsule Delayed Release, Oral, as choline fenofibrate:

Trilipix: 45 mg

Trilipix: 135 mg [contains fd&c blue #2 (indigotine)]

Generic: 45 mg, 135 mg

Tablet, Oral, as fenofibrate:

Fenoglide: 40 mg, 120 mg

Lofibra: 54 mg [contains fd&c yellow #10 aluminum lake]

Lofibra: 160 mg

Tricor: 48 mg [contains fd&c blue #2 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, soybean lecithin]

Tricor: 145 mg [contains soybean lecithin]

Triglide: 50 mg [DSC], 160 mg

Generic: 40 mg, 48 mg, 54 mg, 120 mg, 145 mg, 160 mg

Tablet, Oral, as fenofibric acid:

Fibricor: 35 mg, 105 mg

Generic: 35 mg, 105 mg

Brand Names: U.S.

  • Antara
  • Fenoglide
  • Fibricor
  • Lipofen
  • Lofibra
  • Tricor
  • Triglide
  • Trilipix

Pharmacologic Category

  • Antilipemic Agent, Fibric Acid

Pharmacology

Fenofibric acid, an agonist for the nuclear transcription factor peroxisome proliferator-activated receptor-alpha (PPAR-alpha), downregulates apoprotein C-III (an inhibitor of lipoprotein lipase) and upregulates the synthesis of apolipoprotein A-I, fatty acid transport protein, and lipoprotein lipase resulting in an increase in VLDL catabolism, fatty acid oxidation, and elimination of triglyceride-rich particles; as a result of a decrease in VLDL levels, total plasma triglycerides are reduced by 30% to 60%; modest increase in HDL occurs in some hypertriglyceridemic patients.

Absorption

Increased when taken with meals

Distribution

Widely to most tissues

Metabolism

Fenofibrate is metabolized in the tissue and plasma via esterases to the active form, fenofibric acid; undergoes inactivation by glucuronidation hepatically or renally

Excretion

Urine (~60% as metabolites); feces (25%); hemodialysis has no effect on removal of fenofibric acid from plasma

Time to Peak

2 to 8 hours

Half-Life Elimination

Half-life elimination: Fenofibric acid: Mean: 20 hours (range: 10 to 35 hours); half-life prolonged in patients with renal impairment

Protein Binding

~99%

Special Populations: Renal Function Impairment

In patients with severe renal impairment (CrCl ≤30 mL/minute), clearance of fenofibrate is greatly reduced. Clearance is reduced to a lesser degree in patients with mild to moderate renal impairment (CrCl 30 to 80 mL/minute).

Use: Labeled Indications

Hypercholesterolemia or mixed dyslipidemia: Adjunctive therapy to diet for the reduction of low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-C), triglycerides, and apolipoprotein B (apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adults with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb). Use lipid-altering agents in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

Hypertriglyceridemia: Adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia).

Contraindications

Hypersensitivity to fenofibrate or fenofibric acid or any component of the formulation; active liver disease, including primary biliary cirrhosis and unexplained, persistent liver function abnormality; severe renal impairment or end-stage renal disease (ESRD), including those receiving dialysis; preexisting gallbladder disease; breast-feeding

Documentation of allergenic cross-reactivity for fibrates is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Pregnancy; known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen

Lipidil EZ, Lipidil Micro, Lipidil Supra: Additional contraindications: Allergy to soya lecithin or peanut or arachis oil; chronic or acute pancreatitis; patients <18 years of age; coadministration with HMG-CoA reductase inhibitors in patients with a predisposition for myopathy.

Dosing: Adult

Note: At least 2 to 3 months of therapy is required to determine efficacy.

Hypertriglyceridemia: Oral: Initial:

Antara (micronized): 30 to 90 mg once daily; maximum dose: 90 mg/day

Fenofibrate (micronized): 43 to 130 mg once daily; maximum dose: 130 mg/day

Fenoglide: 40 to 120 mg once daily; maximum dose: 120 mg/day

Fibricor: 35 to 105 mg once daily; maximum dose: 105 mg/day

Lipidil EZ [Canadian product]: 145 mg once daily; maximum dose: 145 mg/day

Lipidil Micro [Canadian product]: 200 mg once daily; maximum dose: 200 mg/day

Lipidil Supra [Canadian product]: 160 mg once daily; maximum dose: 200 mg/day

Lipofen: 50 to 150 mg once daily; maximum dose: 150 mg/day

Lofibra (micronized): 67 to 200 mg once daily; maximum dose: 200 mg/day

Lofibra (tablets): 54 to 160 mg once daily; maximum dose: 160 mg/day

TriCor: 48 to 145 mg once daily; maximum dose: 145 mg/day

Triglide: 160 mg once daily

Trilipix: 45 to 135 mg once daily; maximum dose: 135 mg/day

Hypercholesterolemia or mixed hyperlipidemia: Oral: Initial:

Antara (micronized): 90 mg once daily; maximum dose: 90 mg/day

Fenofibrate (micronized): 130 mg once daily; maximum dose: 130 mg/day

Fenoglide: 120 mg once daily

Fibricor: 105 mg once daily

Lipidil EZ [Canadian product]: 145 mg once daily; maximum dose: 145 mg/day

Lipidil Micro [Canadian product]: 200 mg once daily; maximum dose: 200 mg/day

Lipidil Supra [Canadian product]: 160 mg once daily; maximum dose: 200 mg/day

Lipofen: 150 mg once daily

Lofibra (micronized): 200 mg once daily

Lofibra (tablets): 160 mg once daily

TriCor: 145 mg once daily

Triglide: 160 mg once daily

Trilipix: 135 mg once daily

Dosing: Geriatric

Oral: Initial: Adjust dosage based on renal function; additional product-specific recommendations for initial dose:

Lipidil EZ [Canadian product]: 48 mg once daily

Lofibra (micronized): 67 mg once daily

Lofibra (tablets): 54 mg once daily

Dosing: Renal Impairment

Monitor renal function and lipid panel before adjusting.

Antara (micronized):

CrCl >80 mL/minute or eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl >30 to 80 mL/minute or eGFR 30 to 59 mL/minute/1.73 m2: Initiate at 30 mg once daily

CrCl ≤30 mL/minute or eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dialysis: Use is contraindicated.

Fenofibrate (micronized):

CrCl >80 mL/minute or eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl >30 to 80 mL/minute or eGFR 30 to 59 mL/minute/1.73 m2: Initiate at 43 mg once daily

CrCl ≤30 mL/minute or eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dialysis: Use is contraindicated.

Fenoglide:

CrCl >80 mL/minute or eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl >30 to 80 mL/minute or eGFR 30 to 59 mL/minute/1.73 m2: Initiate at 40 mg once daily

CrCl ≤30 mL/minute or eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dialysis: Use is contraindicated.

Fibricor:

CrCl >80 mL/minute: No dosage adjustment necessary.

CrCl >30 to 80 mL/minute: Initiate at 35 mg once daily

CrCl ≤30 mL/minute: Use is contraindicated.

Dialysis: Use is contraindicated.

Lipidil EZ [Canadian product]: Note: Interrupt treatment in patients with an increase in creatinine concentrations >50% the upper limit of normal (ULN).

CrCl >50 mL/minute: No dosage adjustment necessary.

CrCl 20 to 50 mL/minute: Initiate at 48 mg once daily

CrCl <20 mL/minute: Use is contraindicated.

Dialysis: Use is contraindicated.

Lipidil Micro [Canadian product]: Note: Interrupt treatment in patients with an increase in creatinine concentrations >50% the upper limit of normal (ULN).

CrCl >85 mL/minute (women) or >95 mL/minute (men): No dosage adjustment necessary.

CrCl 20 to 85 mL/minute (women) or 20 to 95 mL/minute (men): Initiate therapy with Lipidil EZ formulation with a dose of 48 mg once daily.

CrCl <20 mL/minute: Use is contraindicated.

Dialysis: Use is contraindicated.

Lipidil Supra [Canadian product]: Note: Interrupt treatment in patients with an increase in creatinine concentrations >50% the upper limit of normal (ULN).

CrCl >100 mL/minute: No dosage adjustment necessary.

CrCl 20 to 100 mL/minute: Initiate at 100 mg once daily

CrCl <20 mL/minute: Use is contraindicated.

Dialysis: Use is contraindicated.

Lipofen:

eGFR ≥90 mL/minute/1.73 m2: No dosage adjustment necessary.

eGFR 30 to 89 mL/minute/1.73 m2: Initiate at 50 mg once daily

eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dialysis: Use is contraindicated.

Lofibra (micronized):

CrCl >80 mL/minute: No dosage adjustment necessary.

CrCl >30 to 80 mL/minute: Initiate at 67 mg once daily

CrCl ≤30 mL/minute: Use is contraindicated.

Dialysis: Use is contraindicated.

Lofibra (tablets):

eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

eGFR 30 to 59 mL/minute/1.73 m2: Initiate at 54 mg once daily

eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dialysis: Use is contraindicated.

TriCor:

eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

eGFR 30 to 59 mL/minute/1.73 m2: Initiate at 48 mg once daily

eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dialysis: Use is contraindicated.

Triglide:

CrCl >80 mL/minute or eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl >30 to 80 mL/minute or eGFR 30 to 59 mL/minute/1.73 m2: Avoid use.

CrCl ≤30 mL/minute or eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dialysis: Use is contraindicated.

Trilipix:

eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

eGFR 30 to 59 mL/minute/1.73 m2: Initiate at 45 mg once daily.

eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dialysis: Use is contraindicated.

Dosing: Hepatic Impairment

Use is contraindicated. Regular monitoring of liver function tests is required; discontinue therapy in patients whose enzyme levels persist above 3 times the upper limit of normal.

Dosing: Adjustment for Toxicity

Cholelithiasis: Discontinue if gallstones are found upon gallbladder studies.

CPK elevation, myopathy, and/or myositis: Discontinue therapy if the patient develops markedly elevated CPK concentrations or if myopathy/myositis is suspected or diagnosed.

HDL-C reductions: Permanently discontinue therapy if HDL-C becomes severely depressed; monitor HDL-C concentrations until returned to baseline.

Administration

Antara, fenofibrate (micronized), Fibricor, Lipidil EZ [Canadian product], Lofibra tablets, TriCor, Triglide, Trilipix: Administer with or without food. Swallow whole; do not open (capsules), crush, dissolve, or chew.

Lipidil Micro [Canadian product]; Lofibra (micronized) capsules: Administer with meals.

Fenoglide, Lipofen, Lipidil Supra [Canadian product]: Administer with meals. Swallow whole; do not open (capsules), crush, dissolve, or chew.

Dietary Considerations

Antara, Fibricor, Lipidil EZ [Canadian product], Lofibra tablets, TriCor, Triglide, Trilipix: May be taken with or without food.

Fenoglide, Lipidil Micro [Canadian product], Lipidil Supra [Canadian product], Lipofen, Lofibra (micronized capsules): Take with meals.

Storage

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect Fibricor, Lipofen, Lofibra, TriCor, Triglide, and Trilipix from moisture. Protect Fibricor, Lofibra tablets, Lipofen, and Triglide from light.

Canadian products: Lipidil EZ, Lipidil Micro, Lipidil Supra: Store at 15°C to 25°C (59°F to 77°F). Protect Lipidil EZ, Lipidil Micro, and Lipidil Supra from moisture. Protect Lipidil EZ and Lipidil Supra from light.

Drug Interactions

Acipimox: May enhance the myopathic (rhabdomyolysis) effect of Fibric Acid Derivatives. Monitor therapy

Amodiaquine: CYP2C8 Inhibitors may increase the serum concentration of Amodiaquine. Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Fibric Acid Derivatives. Management: Separate doses by at least 2 hours to minimize this interaction; fenofibric acid labeling recommends administration one hour prior to or 4-6 hours after a bile acid sequestrant. Exceptions: Colesevelam. Consider therapy modification

Chenodiol: Fibric Acid Derivatives may diminish the therapeutic effect of Chenodiol. Management: Monitor clinical response to chenodiol closely when used together with any fibric acid derivative. Monitor therapy

Ciprofibrate: May enhance the adverse/toxic effect of Fibric Acid Derivatives. Avoid combination

Colchicine: Fibric Acid Derivatives may enhance the myopathic (rhabdomyolysis) effect of Colchicine. Monitor therapy

CycloSPORINE (Systemic): May enhance the nephrotoxic effect of Fibric Acid Derivatives. Fibric Acid Derivatives may decrease the serum concentration of CycloSPORINE (Systemic). Management: Careful consideration of the risks and benefits should be undertaken prior to use of this combination; extra monitoring of renal function and cyclosporine concentrations will likely be required. Adjustment of cyclosporine dose may be necessary. Consider therapy modification

Ezetimibe: Fenofibrate and Derivatives may enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Monitor therapy

HMG-CoA Reductase Inhibitors: Fenofibrate and Derivatives may enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. Monitor therapy

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of Fibric Acid Derivatives. Monitor therapy

Sulfonylureas: Fibric Acid Derivatives may enhance the hypoglycemic effect of Sulfonylureas. Monitor therapy

Tacrolimus (Systemic): May enhance the nephrotoxic effect of Fenofibrate and Derivatives. Monitor therapy

Ursodiol: Fibric Acid Derivatives may diminish the therapeutic effect of Ursodiol. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Fibric Acid Derivatives may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification

Warfarin: Fenofibrate and Derivatives may enhance the anticoagulant effect of Warfarin. Fenofibrate and Derivatives may increase the serum concentration of Warfarin. Consider therapy modification

Adverse Reactions

Frequency not always defined.

Cardiovascular: Pulmonary embolism (≤5%), thrombophlebitis (≤5%)

Central nervous system: Pain (1% to 4%), dizziness (≥3%), insomnia (≥3%), fatigue (2% to 3%)

Dermatologic: Skin rash (1%), urticaria (1%), Stevens-Johnson syndrome, toxic epidermal necrolysis

Gastrointestinal: Abdominal pain (5%), diarrhea (≥3%), dyspepsia (≥3%), cholecystitis (requiring surgery: 2%), constipation (2%)

Hematologic & oncologic: Agranulocytosis, decreased hematocrit (acute; levels stabilize with chronic therapy), decreased hemoglobin (acute; levels stabilize with chronic therapy), decreased white blood cell count (acute; levels stabilize with chronic therapy), thrombocytopenia

Hepatic: Increased serum ALT (≤13%; >3 x ULN; dose dependent), increased serum AST (≤13%; >3 x ULN; dose dependent), abnormal hepatic function tests (8%), cholestatic hepatitis, chronic active hepatitis, hepatocellular hepatitis

Neuromuscular & skeletal: Arthralgia (≥3%), limb pain (≥3%), myalgia (≥3%), increased creatine phosphokinase (3%), myopathy, toxic myopathy

Respiratory: Nasopharyngitis (≥3%), sinusitis (≥3%), upper respiratory tract infection (≥3%), rhinitis (2%)

<1% (Limited to important or life-threatening): Acute renal failure, anemia, decreased HDL cholesterol, hepatic cirrhosis, hepatitis, muscle spasm, myalgia, pancreatitis, renal failure, rhabdomyolysis

Warnings/Precautions

Concerns related to adverse effects:

• Cholelithiasis: May cause cholelithiasis; discontinue if gallstones are found upon gallbladder studies.

• HDL cholesterol (HDL-C): A paradoxical, severe, and reversible decrease in HDL-C (as low as 2 mg/dL) with a simultaneous decrease in apolipoprotein A1 has been reported within 2 weeks to years after initiation of fibrate therapy; clinical significance unknown. Monitor HDL-C within a few months of initiation of therapy and discontinue if HDL-C becomes severely depressed; do not restart therapy.

• Hematologic effects: May cause mild-to-moderate decreases in hemoglobin, hematocrit and WBC upon initiation of therapy which usually stabilizes with long-term therapy. Agranulocytosis and thrombocytopenia have been reported. Periodic monitoring of blood counts is recommended during the first year of therapy.

• Hepatic effects: Hepatic transaminases can become significantly elevated (dose-related); hepatocellular, chronic active, and cholestatic hepatitis have been reported after weeks to several years of therapy. Baseline and regular monitoring of liver function tests is required; discontinue therapy in patients whose enzyme levels persist above 3 times the upper limit of normal.

• Hypersensitivity reactions: Acute hypersensitivity reactions (eg, severe skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported.

• Myopathy/rhabdomyolysis: Has been associated with rare myositis, myopathy, or rhabdomyolysis; monitor patients closely. Risk increased in the elderly, those receiving concomitant HMG-CoA reductase inhibitors or colchicine, and patients with diabetes mellitus, renal insufficiency, or hypothyroidism. Instruct patients to report unexplained muscle pain, tenderness, weakness, especially if accompanied with malaise or fever; or brown urine. Discontinue therapy in patients who develop markedly elevated CPK concentrations or if myopathy/myositis is suspected or diagnosed.

• Renal effects: Increases in serum creatinine (>2 mg/dL) have been observed with use; clinical significance unknown. These elevations tend to return to baseline following discontinuation of fenofibrate. Fenofibrate has been shown to increase creatinine production (unknown mechanism) resulting in an equal increase of creatinuria thereby demonstrating that the increase does not reflect a reduction in creatinine clearance (Hottelart 2002). Monitor renal function in patients with renal impairment; consider monitoring renal function in patients with increased risk for developing renal impairment (eg, elderly and patients with diabetes).

• Venous thromboembolism (VTE): Use has been associated with pulmonary embolism (PE) and deep vein thrombosis (DVT). Use with caution in patients with risk factors for VTE.

Disease-related concerns:

• Cardiovascular disease: Fibric acid derivatives have not demonstrated significant efficacy in altering cardiovascular disease mortality in major clinical studies. In two large randomized controlled clinical trials, neither fenofibrate monotherapy (Keech 2005) nor the addition of fenofibrate to simvastatin (ACCORD Study Group 2010) compared to placebo were shown to reduce cardiovascular disease morbidity and mortality in patients with type 2 diabetes.

• Hepatic impairment: Contraindicated in patients with active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities.

• Renal impairment: Use with caution in patients with mild to moderate renal impairment; dosage adjustment required. Contraindicated in patients with severe renal impairment including those receiving dialysis. Avoid use of Triglide in patients with mild or moderate renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• HMG-CoA reductase inhibitors: Use caution with HMG-CoA reductase inhibitors; may lead to myopathy, rhabdomyolysis. No incremental benefit of combination therapy on cardiovascular morbidity and mortality over statin monotherapy has been established. In combination with HMG-CoA reductase inhibitors, fenofibrate is generally regarded as safer than gemfibrozil due to limited pharmacokinetic interaction with statins. According to the 2013 ACC/AHA Blood Cholesterol Guidelines, fenofibrate may be considered in patients on low- or moderate-intensity statin therapy (ie, statin therapy intended to lower LDL-C by <30% or ~30% to 50%, respectively) only if the benefits from atherosclerotic cardiovascular disease (ASCVD) risk reduction or triglyceride lowering when triglycerides are >500 mg/dL, outweigh the potential risk for adverse effects (Stone 2013).

Special populations:

• Elderly: Use with caution in the elderly; dosage adjustment may be required.

Dosage form specific issues:

• Peanut or arachis oil: Some products may contain peanut or arachis oil; use is contraindicated in patients with a peanut or arachis allergy for applicable formulations.

• Soya lecithin: Some products may contain soya lecithin; use is contraindicated in patients with a soya lecithin allergy for applicable formulations.

Other warnings/precautions:

• Hyperlipidemia: Secondary causes of hyperlipidemia should be ruled out prior to therapy.

• Optimal response: Therapy should be withdrawn if an adequate response is not obtained after 2 to 3 months of therapy at the maximal daily dose. In patients with severe hypertriglyceridemia, the occurrence of pancreatitis may represent a failure of efficacy, a direct effect of the drug, or obstruction of the common bile duct due to biliary tract stone or sludge formation.

Monitoring Parameters

Periodic blood counts during first year of therapy. Monitor lipid profile periodically. Monitor LFTs regularly and discontinue therapy if levels remain >3 times normal limits. Monitor renal function in patients with renal impairment or in those at increased risk for developing renal impairment.

2013 ACC/AHA Blood Cholesterol Guideline recommendations (Stone, 2013): Evaluate renal status at baseline, within 3 months after initiation, and every 6 months thereafter.

Pregnancy Risk Factor

C

Pregnancy Considerations

Maternal toxicity was observed in pregnant rats at doses approximately equivalent to the human dose; adverse events have not been observed in animal reproduction studies done in rabbits. Reports of using fenofibrate during pregnancy are limited (Goldberg, 2012; Sunman, 2012; Whitten, 2011). Other agents are generally preferred if treatment for hypertriglyceridemia during pregnancy (Berglund, 2012) or treatment of lipid disorders in women of reproductive age (NCEP, 2001) is required. Use during pregnancy is specifically contraindicated in Canadian product labeling; some products recommend using effective birth control when treating women of reproductive age and discontinuing therapy several months prior to conception if planning a pregnancy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, back pain, or abdominal pain. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of gallstones (pain in the upper right abdominal area, right shoulder area, or between the shoulder blades; yellow skin or eyes; or fever with chills), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), muscle pain, muscle weakness, severe loss of strength and energy, severe joint pain, severe joint edema, angina, chills, shortness of breath, coughing up blood, urinary retention, change in amount of urine passed, bruising, bleeding, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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