Lipofen

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

☞ 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.