Pharmacologic class: Fibric acid derivative
Therapeutic class: Antihyperlipidemic
Pregnancy risk category C
Increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of Apo CII (an inhibitor of lipoprotein lipase activity)
Capsules (delayed-release): 45 mg, 135 mg
Indications and dosages
➣ Adjunct to diet in combination with a statin in patients with mixed dyslipidemia and coronary heart disease (CHD) or a risk equivalent; adjunct to diet in patients with primary hyperlipidemia or mixed dyslipidemia
Adults: 135 mg P.O. daily
➣ Adjunct to diet in patients with severe hypertriglyceridemia
Adults: 45 to 135 mg P.O. daily
• Mild to moderate renal impairment
• Hypersensitivity to drug, choline fenofibrate, or fenofibrate
• Severe renal impairment, including patients receiving dialysis
• Active liver disease, gallbladder disease
Use cautiously in:
• myositis, myopathy
• administration with maximum dosage of a statin (avoid use unless benefit outweighs risk)
• administration with oral anticoagulants
• pregnant patients
• children (safety and efficacy not established).
• Administer with or without food (but not with large amounts of grapefruit juice) and have patient swallow capsule whole.
• Be aware that drug isn't indicated for patients with elevated chylomicron and plasma triglyceride levels but with normal very-low-density lipoprotein level.
CNS: fatigue, dizziness, headache, insomnia
EENT: nasopharyngitis, sinusitis, pharyngolaryngeal pain, rhinitis
GI: nausea, constipation, diarrhea, dyspepsia, abdominal pain, pancreatitis
GU: urinary tract infection
Musculoskeletal: back pain, muscle spasms, extremity pain, arthralgia, myalgia, musculoskeletal pain, myositis, myopathy, rhabdomyolysis
Respiratory: upper respiratory tract infection, bronchitis, cough, respiratory disorder
Skin: rash, Stevens-Johnson syndrome, toxic epidermal necrolysis (rare)
Other: pain, influenza, acute hypersensitivity
Drug-drug. Bile acid resins: decreased fenofibric acid absorption
Immunosuppressants (such as cyclosporine): increased risk of nephrotoxicity
Oral anticoagulants: prolonged prothrombin time or International Normalized Ratio
Drug-diagnostic tests. Alanine aminotransferase (ALT), aspartate aminotransferase, creatine kinase (CK), hepatic enzymes, serum creatinine: elevated levels
Hematocrit, hemoglobin, WBC: decreased levels
Drug-food. Grapefruit juice (more than 1 qt daily): increased risk of myopathy when fenofibric acid is taken with statins
Drug-behaviors. Alcohol use (excessive): exacerbation of hypertriglyceridemia
☞ Monitor CK level; discontinue drug if markedly elevated CK level occurs or myopathy or myositis is diagnosed.
☞ Regularly monitor liver function tests, including serum ALT; discontinue drug if levels persist above three times upper limit of normal.
☞ Be aware that drug may increase cholesterol excretion into bile, potentially leading to cholelithiasis. Discontinue drug if gallstones develop.
• Monitor serum lipid levels periodically.
• Monitor renal function tests closely in patients at risk for renal insufficiency, such as elderly patients and those with diabetes mellitus.
• Instruct patient to take drug with or without food (but not with large amounts of grapefruit juice) and to swallow capsule whole.
• Instruct patient that if drug is prescribed with another cholesterol-lowering drug called a statin, these drugs should be taken together.
☞ Instruct patient to promptly inform prescriber if unexplained muscle pain, tenderness, or weakness occurs, particularly if accompanied by malaise or fever.
☞ Instruct patient to promptly inform prescriber if skin blistering, peeling, or loosening; red lesions; severe rash; fever; or chills occur because these signs and symptoms may signal a serious skin disorder.
• Advise patient not to take other prescription or nonprescription drugs or herbal or vitamin supplements without first discussing with prescriber.
• 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.
fenofibric acid(feen-ohfye-brik as-id) ,
ClassificationTherapeutic: lipid lowering agents
Pharmacologic: fibric acid derivatives
Time/action profile (effects on blood lipids)
Adverse Reactions/Side Effects
Central nervous system
- headache (most frequent)
- diarrhea (most frequent)
- nausea (most frequent)
- ↑ liver enzymes
- ↑ serum creatinine
- ↓ HDL levels
- myopathy/rhabdomyolysis (life-threatening)
- myalgia (most frequent)
- back pain
Drug-Drug interaction↑ effects and risk of bleeding with warfarin ; monitor prothrombin time/INR.Bile acid sequestrants may ↓ absorption and effectiveness; administer at least 1 hr before or 4–6 hr after a bile acid sequestrant.Concurrent use with nephrotoxic drugs including cyclosporine may impair renal function and excretion, ↑ risk of adverse reactions.Concurrent use with colchicine may ↑ risk of rhabdomyolysis
Primary Hypercholesterolemia or Mixed Dyslipidemia
Renal ImpairmentOral (Adults) CCr 30–80 mL/min—Fibricor: Initiate with 35 mg once daily; may titrate cautiously; TriLipix: Initiate with 45 mg once daily; may titrate cautiously; CCr <30 mL/min—Contraindicated.
Availability (generic available)
- 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 fenofibric acid 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. Discontinue therapy if levels rise >3 times the normal limit.
- If patient develops muscle tenderness during therapy, CPK levels should be monitored. If CPK levels are markedly ↑ or myopathy occurs, therapy should be discontinued.
- May cause reversible ↑ in serum creatinine. Monitor renal function in patients at risk for renal insufficiency (elderly, diabetics).
- 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 time and INR monitored frequently until levels stabilize in patients taking anticoagulants concurrently.
Potential Nursing DiagnosesNoncompliance (Patient/Family Teaching)
- Patients should be placed on a triglyceride-lowering diet before therapy and remain on this diet throughout therapy.
- Oral: Administer without regard to meals. Swallow capsules whole; do not open, crush, or chew. May be administered at same time as statin dose.
- Instruct patient to take medication as directed. Take missed doses as soon as remembered; if time for next dose, skip dose and take next dose at regular time. Do not double doses. Medication helps control but does not cure elevated serum triglyceride levels. Advise patient to read Medication Guide before starting and with each Rx refill, as new information may be available.
- 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, weakness, tiredness, fever, nausea, vomiting, or abdominal pain occurs, especially if accompanied by fever or malaise.
- Instruct female patients to notify health care professional promptly if pregnancy is planned or suspected.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise patient to notify health care professional of medication regimen before treatment or surgery.
- Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.
- Decrease in serum triglycerides and LDL cholesterol to normal levels with an increase in HDL levels.