Trilipix

(Fenofibric Acid DR)

The active ingredient in Trilipix is fenofibric acid, which is a fibrate medication. It belongs to a group of prescription drugs that affect lipid levels in the blood, including triglycerides, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). The effects of fenofibric acid help lower high triglyceride and HDL cholesterol levels.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Trilipix. However, the following is a synopsis of the general guidelines for the use of Trilipix:

• The recommended dose will depend on the indication for Trilipix. It is usually 45 mg or 135 mg once daily. Your healthcare provider will know what dose is best for you.
• Trilipix is a delayed-release capsule that is typically taken by mouth once daily. Swallow the capsule whole and take Trilipix at the same time each day to help maintain consistent lipid levels. It can be taken with or without food.
• Do not crush, chew, or open the capsule.
• Trilipix is often prescribed as an adjunct to diet and lifestyle changes.
• Your healthcare provider may order baseline and follow-up blood tests to monitor liver function, bilirubin, renal function, serum creatinine, and lipid levels.
• Elderly patients and those with renal impairment may require closer monitoring due to an increased risk of adverse reactions.

Some mild or common side effects of Trilipix seen in clinical trials as compared to placebo include:

• Headache.
• Back pain.
• Abdominal pain.
• Diarrhea.
• Muscle pain.
• Increased liver enzymes such as AST and ALT.

Some individuals may experience serious side effects while using Trilipix. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe muscle pain, tenderness, or weakness may be signs of myopathy or rhabdomyolysis.
• Signs of liver injury, such as yellowing of the skin or eyes, dark urine, weight loss, or persistent nausea.
• Gallbladder disease and cholelithiasis (gallstones) symptoms include upper abdominal pain, fever, or jaundice.
• Pancreatitis symptoms, such as severe abdominal pain that may radiate to the back.
• Signs of a severe allergic reaction, including rash, itching, swelling of the face or throat, or difficulty breathing.

These are not all of the possible side effects of Trilipix. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Trilipix, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Liver disease (hepatic disease) or abnormal liver function tests.
• Renal impairment or kidney disease.
• Gallbladder disease or a history of gallstones.
• Hypothyroidism.
• Diabetes mellitus.
• A history of muscle disorders or muscle pain.
• Cardiovascular disease or heart disease.
• A history of pancreatitis.
• Cirrhosis or other chronic liver conditions.
• Known hypersensitivity reactions to fibrates or fenofibrate.

• Severe renal impairment, including patients receiving dialysis.
• Active liver disease.
• Gallbladder disease.
• Known hypersensitivity to fenofibric acid or any component of the Trilipix formulation.
• Breastfeeding mothers.

Trilipix begins to affect lipid levels after starting treatment, but noticeable changes in triglycerides and cholesterol levels are usually seen within several weeks. Full effects may take longer and depend on factors such as baseline lipid levels, adherence to therapy, diet, and overall health. Regular follow-up appointments and blood tests help assess treatment response.

When Trilipix is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Statins, such as atorvastatin, simvastatin, pravastatin, or rosuvastatin, are associated with an increased risk of myopathy and rhabdomyolysis.
• Warfarin and other anticoagulants, as Trilipix is a CYP2C9 inhibitor and may increase the risk of bleeding by enhancing anticoagulant effects. More frequent INR monitoring may be needed.
• Cyclosporine or tacrolimus may increase the risk of renal impairment.
• Colchicine, due to an increased risk of muscle-related adverse reactions.
• Bile acid sequestrants may interfere with the absorption of Trilipix if not properly timed.

Trilipix is available in delayed-release capsule dosage forms of 45 mg and 135 mg. Your healthcare provider will determine the appropriate dose based on your lipid levels, renal function, and overall treatment plan.

Trilipix should be stored at room temperature, away from the reach of children or pets.

Trilipix is manufactured by AbbVie Inc.

Yes, generic versions containing fenofibric acid delayed-release capsules are available.

Do not stop taking Trilipix without first talking to your healthcare provider. Stopping treatment suddenly may cause lipid levels, including triglycerides, to rise again. Your healthcare provider will guide you on safe discontinuation or transition to another therapy if needed.

Trilipix is generally not recommended during pregnancy unless the potential benefit outweighs the possible risks. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known whether fenofibric acid passes into breast milk, and breastfeeding is generally not recommended during Trilipix therapy. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.