FENOFIBRATE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Antara
• Lipofen
• Lofibra
• Tricor
• Triglide

In Canada?

• Lipidil Micro
• Lipidil Supra

Category

• Antihyperlipidemic

Description

Fenofibrate (fen-o-FI-brate) is used to lower triglyceride (fat-likesubstances) levels and cholesterol levels in the blood. This may help preventthe development of pancreatitis (inflammation of the pancreas) caused by highlevels of triglycerides in the blood.

This medicine is available only with your doctor's prescription, in thefollowing dosage form(s):

Oral
• Capsules (U.S. and Canada)
• Tablets (U.S. and Canada)

Before Using This Medicine

In addition to its helpfuleffects in treating your medical problem, this type of medicine may have someharmful effects.

Results of large studies using other agents that are similar to fenofibrateseem to suggest that fenofibrate may increase the patient's risk of cancer,pancreatitis (inflammation of the pancreas), gallstones, and problems fromgallbladder surgery.

Studies with fenofibrate in rats found an increased risk of liver and pancreatictumors when doses up to 6 times the human dose were given for a long time.

Be sure you have discussed this with your doctor before taking this medicine.

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For fenofibrate, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to fenofibrate. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Fenofibrate has not been studied in pregnant women.However, studies in animals have shown that high doses of fenofibrate mayincrease the number of fetal deaths, decrease birth weight, or cause someskeletal defects. Before taking this medicine, make sure your doctor knowsif you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether fenofibrate passes intobreast milk. Studies in animals have shown that high doses of fenofibratemay increase the risk of some kinds of tumors. Therefore, this medicine isnot recommended for use during breast-feeding.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of fenofibratein children with use in other age groups.

Older adults?Although the effects of fenofibrate have not beenfully tested in older people, this medicine has been tested in a limited numberof patients 77 through 87 years of age and has not been shown to cause problemswhen given to older people.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingfenofibrate, it is especially important that your health care professionalknow if you are taking any of the following:

• Anticoagulants (blood thinners)?Use with fenofibrate may increasethe effect of the anticoagulant and increase the risk of bleeding.

• Carmustine (e.g., BiCNU) or
• Cisplatin (e.g., Platinol) or
• Combination pain medicine containing acetaminophen and aspirin (e.g.,Excedrin) or other salicylates or
• Cyclosporine (e.g., Sandimmune) or
• Deferoxamine (e.g., Desferal) (with long-term use) or
• Gold salts (medicine for arthritis) or
• Inflammation or pain medicine, except narcotics, or
• Lithium (e.g., Lithane) or
• Methotrexate (Mexate) or
• Other medicine for infection or
• Penicillamine (e.g., Cuprimine) or
• Plicamycin (e.g., Mithracin) or
• Streptozocin (e.g., Zanosar) or
• Tiopronin (Thiola)?Concurrent use of these medicines with fenofibratemay increase the chance for side effects, especially when kidney disease ispresent.

• HMG-CoA reductase inhibitors (atorvastatin [e.g., Lipitor], cerivastatin[e.g., Baycol], fluvastatin [e.g., Lescol], lovastatin [e.g., Mevacor], pravastatin[e.g., Pravacol], simvastatin [e.g., Zocor])?Use with fenofibrate maycause muscle or kidney problems or make them worse.

Other medical problems?The presence of other medicalproblems may affect the use of fenofibrate. Make sure you tell your doctorif you have any other medical problems, especially:

• Gallbladder disease or
• Gallstones or
• Liver disease?Fenofibrate may make these conditions worse.You should NOT use fenofibrate if you have any of these conditions.

• Kidney disease?Higher blood levels of fenofibrate may result,which may increase the chance of side effects or make kidney problems worse.If you have severe kidney problems, you should NOT use fenofibrate.

Proper Use of This Medicine

Before prescribingmedicine for your condition, your doctor will probably try to control yourcondition by prescribing a personal diet for you. Such a diet may be low infats, sugars, and/or cholesterol. Many people are able to control their conditionby carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is neededand is effective only when a schedule of diet and exercise is properly followed.

Use this medicine only as directed by your doctor. Take the medication at the same time each day to maintain the medication'seffect. Do not use more or less of it, and do not use it more often than yourdoctor ordered.

Follow carefully the special diet your doctor gaveyou. This is the most important part of controlling your conditionand is necessary if the medicine is to work properly.

This medicine is usually taken once a day. Lipofen[trade ] and Lofibra[trade ]should be taken with a meal. Antara[trade ], Tricor[reg ], and Triglide[trade ]can be taken with or without a meal.

Dosing?The dose of fenofibrate will bedifferent for different patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of fenofibrate. If your dose isdifferent, do not change it unless your doctor tells you to do so:

• For oral dosage form (capsules):
  • For hypertriglyceridemia (to lower triglycerides):
    • Adults?
      • Antara[trade ]?At first, 43 milligrams (mg) once a day witha meal. Your doctor may increase your dose as needed.
      • Lipofen[trade ]?At first, 50 to 150 milligrams (mg) once a daywith a meal. Your doctor may increase your dose as needed.
      • Lofibra[trade ]?At first, 67 milligrams (mg) once a day witha meal. Your doctor may increase your dose as needed.
      .
  • For hypercholesteremia (to lower cholesterol):
    • Adults?
      • Antara[trade ]?130 milligrams (mg) once a day with a meal.
      • Lipofen[trade ]?150 milligrams (mg) once a day with a meal.
      • Lofibra[trade ]?200 milligrams (mg) once a day with a meal.

• For oral dosage form (tablets):
  • For hypertriglyceridemia (to lower triglycerides):
    • Adults?
      • Tricor[reg ]?At first, 48 to 145 milligrams (mg) once daily.Your doctor may increase your dose as needed.
      • Triglide[reg ]?At first, 50 to 160 milligrams (mg) once daily.Your doctor may increase your dose as needed.
  • For hypercholesteremia (to lower cholesterol):
    • Adults?
      • Tricor[reg ]?145 milligrams (mg) once daily.
      • Triglide[reg ]?160 milligrams (mg) once daily.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits. This will allow your doctor to see if the medicineis working properly to lower your triglyceride levels and to decide if youshould continue to take it.

Check with your doctor right away if you experienceunexplained muscle pain, tenderness, or weakness, especially if accompaniedby unusual tiredness or fever.

Check with your doctor right away if you think that you may be pregnant.Fenofibrate may cause birth defects or other problems in the baby if takenduring pregnancy.

Check with your doctor right away if you have signs of an infection, suchas a fever, sore throat, or chills.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

Rare

Chills, fever, or sore throat

Check with your doctor assoon as possible if any of the following side effects occur:

Less common

Chills, fever, muscle aches and pains, or nausea and/or vomiting; hives; infections; itching (generalized); skin rash

Rare

Bloating or pain of the stomach; chronicindigestion; cough and shortness of breath or troubledbreathing; dark urine; general ill feeling; loss of appetite; muscle cramps, pain, stiffness, swelling, or weakness; nausea; unusual bleeding or bruising; unusual tiredness; vomiting; yellow eyes or skin

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

More common

Chest congestion; difficulty breathing

Less common

Back pain; belching; constipation; decreased sexual drive; diarrhea; dizziness; eye irritation; gas; headache; increased sensitivity of the skin to sunlight; lack or loss of strength; stomach pain; stuffy nose

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.