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Primary Hypercholesterolemia or Mixed Dyslipidemia
LIPOFEN is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
LIPOFEN is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Fenofibrate at a dose equivalent to 150 mg of LIPOFEN was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS].
DOSAGE AND ADMINISTRATION
LIPOFEN Capsules should be given with meals thereby optimizing the absorption of the medication.
Patients should be advised to swallow LIPOFEN capsules whole. Do not open, crush, dissolve or chew capsules.
Patients should be placed on an appropriate lipid-lowering diet before receiving LIPOFEN, and should continue this diet during treatment with LIPOFEN.
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.
Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of LIPOFEN. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 150 mg per day.
Consideration should be given to reducing the dosage of LIPOFEN if lipid levels fall significantly below the targeted range.
Primary Hypercholesterolemia or Mixed Dyslipidemia
The dose of LIPOFEN is 150 mg once daily.
The initial dose is 50 to 150 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determination at 4 to 8 week intervals.
The maximum dose of LIPOFEN is 150 mg once daily.
Impaired Renal Function
In patients with mild-to-moderate renal impairment, treatment with LIPOFEN should be initiated at a dose of 50 mg per day, and increased only after evaluation of the effects on renal function and lipid levels at this dose.
Dosage Forms And Strengths
- 50 mg: Size 3 white opaque gelatin capsule imprinted “G 246” and “50” in black ink.
- 150 mg: Size 1 white opaque gelatin capsule imprinted “G 248” and “150” in green ink.
Storage And Handling
LIPOFEN® (fenofibrate) Capsules, USP is available in two strengths:
50 mg: Size 3 white opaque/white opaque gelatin capsule, imprinted in black ink with “50” between lines on the body, “G 246” on the cap and containing a white to almost white paste, available in bottles of 30 (NDC 66869-137-20) and 90 (NDC 66869-137-30).
150 mg: Size 1 white opaque/white opaque gelatin capsule, imprinted in green ink with “150” between lines on the body, “G 248” on the cap and containing a white to almost white paste, available in bottles of 30 (NDC 66869-147-20) and 90 (NDC 66869-147-30).
Store at Controlled Room Temperature, 15°C - 30°C (59°F - 86°F). Keep out of the reach of children. Protect from moisture and light.
Manufactured into capsules by: Galephar Pharmaceutical Research Inc. Humacao, PR 00741. Manufactured for: Kowa Pharmaceuticals America, Inc. Montgomery, AL 36117. Revised 01/2013
Last reviewed on RxList: 2/1/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Lipofen Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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