Lofibra (Oral)

Fenofibrate is used along with a proper diet to lower and manage high cholesterol and triglyceride (fat-like substances) levels in the blood. This can help prevent pancreatitis (inflammation or swelling of the pancreas) that can occur due to high triglyceride levels in the blood.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits. This will help your doctor determine if the medicine is effectively lowering your cholesterol and triglyceride (fat) levels and decide if you should keep taking it. Blood and urine tests may be needed to check for side effects.

Call your doctor immediately if you have a headache, stomach pain, vomiting, dark urine, loss of appetite, weight loss, general tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be signs of liver problems.

Contact your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also feel unusually tired or have a fever. These could indicate a serious muscle issue called myopathy.

Speak to your doctor immediately if you have dark urine, diarrhea, fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be signs of a serious muscle condition called rhabdomyolysis, which can lead to kidney issues.

Pancreatitis may happen while you are using this medicine. Inform your doctor right away if you experience bloating, sudden and severe stomach pain, chills, diarrhea, fast heartbeat, fever, indigestion, loss of appetite, nausea, stomach pain, side pain, or abdominal pain that may spread to your back, or vomiting.

This medicine may increase your risk of developing gallstones. Consult your doctor immediately if you have severe stomach pain, especially after eating, along with nausea and vomiting.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and need immediate medical help. Notify your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or swelling of your hands, face, or mouth after using this medicine.

Serious skin reactions, including Steven-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), can occur with this medicine. Contact your doctor immediately if you experience blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, rash, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may reduce the number of certain types of blood cells in your body. Because of this, you may be more prone to bleeding or infections. To help with these issues, avoid close contact with sick people. Wash your hands regularly. Stay away from rough sports or situations where you might get bruised, cut, or injured. Brush and floss your teeth gently. Be cautious when using sharp objects, including razors and fingernail clippers.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of fenofibrate in children. Its safety and effectiveness have not been established in the pediatric population.

Geriatric

Appropriate studies done so far have not shown any specific problems in elderly patients that would limit the usefulness of fenofibrate. However, older adults are more likely to have age-related kidney issues, which may require caution and a dose adjustment for patients taking fenofibrate.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. You should either be prescribed an alternative to this medication or stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ciprofibrate

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Acenocoumarol
• Anisindione
• Atorvastatin
• Colchicine
• Dicumarol
• Ezetimibe
• Fluvastatin
• Lovastatin
• Phenprocoumon
• Pitavastatin
• Pravastatin
• Rosuvastatin
• Simvastatin
• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Colestipol
• Cyclosporine
• Rosiglitazone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), past history of
• Heart disease or
• Muscle pain or tenderness, past history of or
• Muscle weakness, past history of—Use with caution. May worsen these conditions.

• Diabetes or
• Hypothyroidism (an underactive thyroid) or
• Kidney problems—Use with caution. May worsen side effects.

• Gallbladder disease, past history of or
• Severe kidney disease (e.g., end-stage kidney disease, those receiving dialysis) or
• Active liver disease (including cirrhosis)—Should not be used in patients with these conditions.

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

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

Less common

• Chills
• fever
• hives, itching, skin rash
• muscle aches and pains
• nausea
• stomach pain
• vomiting

Rare

• Dark urine
• muscle cramps, spasms, stiffness, swelling, or weakness
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Incidence not known

• Agitation
• bloating
• bloody urine
• constipation
• cough
• decreased frequency or amount of urine
• difficulty in moving
• fast heartbeat
• increased blood pressure
• increased thirst
• indigestion
• joint pain or swelling
• light-colored stools
• loss of appetite
• lower back or side pain
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• swelling of the face, fingers, or lower legs
• upper right stomach pain
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Runny or stuffy nose
• sneezing

Less common

• Back pain
• diarrhea
• eye irritation
• gas
• increased sensitivity of the skin to sunlight

Incidence not known

• Lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Antara
• Fenoglide
• Lipofen
• Lofibra
• Tricor
• Triglide

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antihyperlipidemic

Chemical Class: Fibric Acid

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet. If you have excess body weight, your doctor may tell you to exercise to lose this weight before using this medicine. Also avoid drinking alcohol before and during treatment with fenofibrate.

This medicine is usually taken once a day. Take the medicine at the same time each day to maintain the medication's effect.

Fenoglide®, Lipofen®, Lofibra™, and Tricor® should be taken with a meal. Antara® and Triglide® can be taken with or without a meal.

Swallow Antara® capsules, Fenoglide® tablets, Tricor® tablets, or Triglide® tablets whole. Do not open, crush, break, chew, or dissolve them. Do not take chipped or broken Triglide® tablets.

If you are also using cholestyramine, colesevelam, or colestipol, you must take Triglide® or Fenoglide® at least 1 hour before or 4 to 6 hours after you take these medicines.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules): For high cholesterol: Adults— Antara®: At first, 130 milligrams (mg) once a day with a meal. Your doctor may adjust your dose as needed. Lipofen®: At first, 150 mg once a day with a meal. Your doctor may adjust your dose as needed. Lofibra™: 200 mg once a day with a meal. Children—Use and dose must be determined by your doctor. For severe hypertriglyceridemia (high triglycerides or fats): Adults— Antara®: At first, 43 to 130 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 130 mg per day. Lipofen®: At first, 50 to 150 mg once a day with a meal. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day. Lofibra™: At first, 67 mg once a day with a meal. Your doctor may increase your dose as needed. Children—Use and dose must be determined by your doctor.

• For oral dosage form (tablets): For high cholesterol: Adults— Fenoglide®: At first, 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. Tricor®: At first, 160 mg once a day. Your doctor may adjust your dose as needed. Triglide®: 160 mg once a day. Children—Use and dose must be determined by your doctor. For high triglycerides or fats: Adults— Fenoglide®: At first, 40 to 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day. Tricor®: At first, 54 to 160 mg once a day. Your doctor may adjust your dose as needed. Triglide®: 160 mg once a day. Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep Triglide® tablets in its original container. Protect from heat, light, and moisture.