TriCor
fenofibrate
Pharmacologic class: Fibric acid derivative
Therapeutic class: Antihyperlipidemic
Pregnancy risk category C
Action
Inhibits triglyceride synthesis in liver, reducing levels of low- and very-low-density lipoproteins. Also increases uric acid secretion.
Availability
Capsules: 50 mg, 150 mg
Capsules (micronized): 43 mg, 67 mg, 130 mg, 134 mg, 200 mg
Tablets: 48 mg, 50 mg, 54 mg, 145 mg, 160 mg
Indications and dosages
➣ Adjunct to dietary therapy to reduce elevated low-density lipoproteins (LDL)-C, total cholesterol, triglycerides, and apolipoprotein B; to increase high-density lipoprotein-C level in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb)
Adults: 1 tablet (145 or 160 mg), 1 capsule (150 mg), or 1 micronized capsule (130 or 200 mg) P.O. daily
➣ Hypertriglyceridemia
Adults: Initially, 50 to 150 mg P.O. daily (capsule); 43 to 200 mg P.O. daily (micronized capsule); 48 to 160 mg P.O. daily (tablet)
Dosage adjustment
• Renal impairment
• Elderly patients
Off-label uses
• Polymetabolic syndrome X
Contraindications
• Hypersensitivity to drug
• Hepatic disease or unexplained, persistent liver function test abnormalities
• Severe renal impairment
• Gallbladder disease
• Breastfeeding
Precautions
Use cautiously in:
• pancreatitis, cholelithiasis
• patients receiving warfarin concurrently
• pregnant patients
• children.
Administration
See Before giving, be aware of potentially serious interactions, such as with nephrotoxic drugs.
• Administer with meals.
• Give bile acid sequestrants at least 1 hour before or 4 to 6 hours after fenofibrate.
Adverse reactions
CNS: drowsiness, dizziness, fatigue, headache, migraine, insomnia, depression, vertigo, nervousness, anxiety, paresthesia, hypotonia, neuralgia
CV: tachycardia, varicose veins, phlebitis, angina, hypertension, hypotension, peripheral vascular disease, vasodilation, ECG abnormalities, coronary artery disease, arrhythmias, ventricular extrasystoles, myocardial infarction, atrial fibrillation
EENT: conjunctivitis, abnormal vision, cataracts, refraction disorder, otitis media, rhinitis, sinusitis, pharyngitis, laryngitis
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, dyspepsia, gastritis, gastroenteritis, esophagitis, duodenal or peptic ulcer, colitis, cholelithiasis, cholecystitis, rectal disorder, rectal hemorrhage
GU: urinary frequency, dysuria, cystitis, urolithiasis, prostatic disorder, gynecomastia, vaginal candidiasis, decreased libido, renal dysfunction
Hematologic: eosinophilia, anemia, lymphadenopathy, thrombocytopenia, leukopenia
Hepatic: fatty liver deposits
Metabolic: hyperuricemia, gout, hypoglycemia
Musculoskeletal: back, muscle, or joint pain; myositis; arthritis; tenosynovitis; arthrosis; bursitis
Respiratory: respiratory disorders, bronchitis, increased cough, dyspnea, pneumonia, asthma
Skin: rash, pruritus, urticaria, bruising, acne, eczema, diaphoresis, dermatitis, herpes simplex, herpes zoster, alopecia, nail disorder
Other: weight loss or gain, edema, fever, flulike symptoms, hypersensitivity reactions
Interactions
Drug-drug. Bile acid sequestrants (resins): decreased absorption and efficacy of fenofibrate
Immunosuppressants, other nephrotoxic drugs: increased risk of renal toxicity
Oral anticoagulants: increased risk of bleeding
Statins (such as simvastatin): rhabdomyolysis, acute renal failure
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, creatinine, gamma-glutamyltransferase, uric acid: increased values
Granulocytes, hemoglobin, neutrophils, platelets, white blood cells (WBCs): decreased values
Liver function tests: abnormal results
Drug-food. Any food: increased drug absorption
Drug-behaviors. Alcohol use: elevated triglyceride level
Patient monitoring
• Assess creatine kinase and lipid levels and liver function test results.
• Monitor CBC and WBC count. Expect these to decrease at start of therapy, then stabilize.
Patient teaching
• Instruct patient to take with meals for best effect.
• Remind patient that he still needs to follow a triglyceride-lowering diet.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Advise patient to minimize GI upset by eating frequent, small servings of food and drinking plenty of fluids.
• Tell patient that drug may take up to 2 months to alter lipid values.
• Inform breastfeeding patient that she must choose between taking fenofibrate and breastfeeding.
• Tell female patient to inform prescriber if she is pregnant.
• Inform patient that he'll undergo regular blood testing.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.
fenofibrate
(fen-o-fi-brate) fenofibrate,Antara
(trade name),Fenoglide
(trade name),Fenomax
(trade name),Lipidil EZ
(trade name),Lipidil Micro
(trade name),Lipidil Supra
(trade name),Lipofen
(trade name),Lofibra
(trade name),Tricor
(trade name),Triglide
(trade name)Classification
Therapeutic: lipid lowering agentsPharmacologic: fibric acid derivatives
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (lowering of triglycerides)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | unknown | 2 wk | unknown |
Contraindications/Precautions
Adverse Reactions/Side Effects
Central nervous system
- fatigue/weakness (most frequent)
- headache
Cardiovascular
- pulmonary embolism (life-threatening)
- arrhythmias
- deep vein thrombosis
Gastrointestinal
- cholelithiasis
- pancreatitis
Dermatologic
- rash (most frequent)
- urticaria
Metabolic
- ↓ HDL levels
Musculoskeletal
- rhabdomyolysis
Miscellaneous
- hypersensitivity reactions
Interactions
Drug-Drug interaction
↑ anticoagulant effects of warfarin.HMG-CoA reductase inhibitors ↑ risk of rhabdomyolysis (concurrent use should be avoided).Absorption is ↓ by bile acid sequestrants (fenofibrate should be given 1 hr before or 4–6 hr after).↑ risk of nephrotoxicity with cyclosporine.Concurrent use with colchicine may ↑ risk of rhabdomyolysisRoute/Dosage
Primary hypercholesterolemia/mixed dyslipidemia
Hypertriglyceridemia
Renal impairment/Geriatric patients
Availability (generic available)
Nursing implications
Nursing assessment
- Obtain a diet history, especially with regard to fat consumption. Every attempt should be made to obtain normal serum triglyceride levels with diet, exercise, and weight loss in obese patients before fenofibrate therapy is instituted.
- Assess patient for cholelithiasis. If symptoms occur, gallbladder studies are indicated. Discontinue therapy if gallstones are found.
- Lab Test Considerations: Monitor serum lipids before therapy to determine consistent elevations, then monitor periodically during therapy.
- Monitor serum AST and ALT periodically during therapy. May cause ↑ levels. Therapy should be discontinued if levels rise >3 times the normal limit.
- If patient develops muscle tenderness during therapy, monitor CPK levels. If CPK levels are markedly ↑ or myopathy occurs, discontinue therapy.
- May cause mild to moderate ↓ in hemoglobin, hematocrit, and WBCs. Monitor periodically during first 12 mo of therapy. Levels usually stabilize during long-term therapy.
- Monitor prothrombin levels frequently until levels stabilize in patients taking anticoagulants concurrently.
Potential Nursing Diagnoses
Noncompliance (Patient/Family Teaching)Implementation
- Do not confuse Tricor with Tracleer (bosentan).
- Place patients on a triglyceride-lowering diet before therapy and remain on this diet throughout therapy.
- Dose may be increased after repeated serum triglyceride levels every 4–8 wk.
- Brands are not interchangeable.
- Oral: Administer Antara, Fenoglide, Lipofen, Lipidil Micro, Lipidil Supra, Lofibra, and Tricor products with meals. Triglide formulation may be taken without regard to meals.
Patient/Family Teaching
- Instruct patient to take medication as directed, not to skip doses or double up on missed doses. Medication helps control but does not cure elevated serum triglyceride levels.
- Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
- Instruct patient to notify health care professional if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
- Advise patient to notify health care professional of medication regimen before treatment or surgery.
- Instruct female patients to notify health care professional promptly if pregnancy is planned or suspected.
- Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.
Evaluation/Desired Outcomes
- Decrease in serum triglycerides and cholesterol to normal levels. Therapy should be discontinued in patients who do not have an adequate response in 2 mo of therapy.
TriCor®
Fenofibrate Cardiology An adjunct to diet for managing stratospheric serum TG levels in Pts unresponsive to diet or at risk of pancreatitisPatient discussion about TriCor
Q. Improving High Triglycerides I take Tricor for high triglyceride levels; I have a healthy level of total cholesterol, with low LDL, very good HDL. I am now being treated for hypothyroidism, but my doctor says that it's also genetic (I had almost the exact same level number as my brother). How can I work to get my triglycerides under control?