Trilipix

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Apixaban
• Argatroban
• Atorvastatin
• Bemiparin
• Bivalirudin
• Cerivastatin
• Colchicine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Dicumarol
• Drotrecogin Alfa
• Enoxaparin
• Fluvastatin
• Fondaparinux
• Heparin
• Lepirudin
• Lovastatin
• Nadroparin
• Phenindione
• Phenprocoumon
• Pitavastatin
• Pravastatin
• Protein C
• Rivaroxaban
• Rosuvastatin
• Simvastatin
• Tinzaparin
• Warfarin

Using this medicine with any of the following medicines may cause an increased 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.

• Ezetimibe
• Rosiglitazone

• AbbVie Inc.

You should not take fenofibric acid if you are allergic to it, or if you have:

• severe kidney disease (or if you are on dialysis);

• liver disease;

• gallbladder disease; or

• if you are breast-feeding a baby.

To make sure you can safely take fenofibric acid, tell your doctor if you have any of these other conditions:

• kidney disease;

• diabetes; or

• underactive thyroid.

FDA pregnancy category C. It is not known whether fenofibric acid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Do not breast-feed while you are taking fenofibric acid.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Avoid eating foods that are high in fat or cholesterol. Fenofibric acid will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Fenofibric acid is used together with a proper diet to treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation of the pancreas) caused by high levels of triglycerides in the blood.

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

This section provides information on the proper use of a number of products that contain fenofibric acid. It may not be specific to Trilipix. Please read with care.

Use 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.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

Swallow the delayed-release capsule whole. Do not open, crush, break, or chew it.

You may take this medicine with or without food.

This medicine will not cure your high cholesterol problem, but it does help control it. You must continue to take it as directed if you expect to keep your cholesterol levels down.

If you are also using cholestyramine, colesevelam, or colestipol, you must take fenofibric acid 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 (delayed-release capsules):
  • For high triglycerides:
    • Adults—At first, 45 to 135 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For mixed dyslipidemia or primary hypercholesterolemia:
    • Adults—135 milligrams (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

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

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.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Trilipix:

• severe kidney disease (or if you are on dialysis);
• liver disease;

• gallbladder disease; or

• if you are breast-feeding a baby.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take Trilipix, tell your doctor if you have:

• kidney disease;

• diabetes; or

• underactive thyroid.

FDA pregnancy category C. It is not known whether Trilipix will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not breast-feed while you are taking Trilipix.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Symptoms of a Trilipix overdose are not known.

In rare cases, Trilipix can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking Trilipix and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Get emergency medical help if you have any of these signs of an allergic reaction to Trilipix: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking Trilipix and call your doctor at once if you have any of these other serious side effects:

• sharp stomach pain spreading to your back or shoulder blade;

• stomach pain just after eating a meal;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• pain, swelling, warmth, or redness in one or both legs; or

• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.

Less serious Trilipix side effects may include:

• headache, dizziness;

• back pain;

• joint pain, mild back pain;

• diarrhea, upset stomach; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.