Triglide

(Fenofibrate)

The active ingredient in Triglide is fenofibrate. Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) agonist. After oral administration, fenofibrate is converted in the body to fenofibric acid, the active form. The mechanism of action of fenofibric acid helps the body process fats more effectively, leading to lower triglyceride levels and changes in cholesterol particles such as very low-density lipoprotein (VLDL), low-density lipoprotein cholesterol (LDL-C), and HDL cholesterol (HDL-C). These effects of fenofibrate support improved lipid balance in people with severe hypertriglyceridemia or mixed dyslipidemia.

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

• The recommended dose is 160 mg once daily or as prescribed by your health care provider.
• Triglide is taken by mouth once daily. Swallow tablets whole. Do not crush, chew, or split them. Take Triglide at the same time each day to help maintain consistent drug levels.
• Triglide tablets can be taken without regard to meals.
• Continue following your prescribed low-fat diet and lifestyle recommendations.
• Regular blood tests may be ordered to monitor triglycerides, liver function, and renal function, such as serum creatinine.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue as scheduled.

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

• Abdominal pain.
• Back pain.
• Headache.
• Constipation.
• Muscle pain or myalgia.

Some individuals may experience serious side effects while using Triglide. 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, weakness, or tenderness may be signs of myopathy or rhabdomyolysis.
• Dark-colored urine or reduced urine output.
• Severe abdominal pain, nausea, or vomiting, which may be linked to pancreatitis or gallbladder disease.
• Yellowing of the skin or eyes, which may indicate liver disease.
• Skin rash, blistering, or peeling skin, including severe allergic or hypersensitivity reactions.
• Chest pain or unexplained fatigue.
• Allergic reaction. Signs include hives and swelling of the face, lips, or tongue.
• Cholelithiasis.

These are not all of the possible side effects of Triglide. 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 Triglide, 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 or abnormal liver enzyme levels.
• Kidney problems or renal impairment.
• Gallbladder disease or a history of gallstones.
• Hypothyroidism.
• Diabetes mellitus.
• A history of muscle disorders or muscle pain related to lipid-lowering therapy.
• A history of hypersensitivity reactions to fibrates.
• Heart disease or cardiovascular risk factors, like a previous myocardial infarction.

• Severe renal impairment or those receiving dialysis.
• Active liver disease, including unexplained persistent liver abnormalities.
• Pre-existing gallbladder disease.
• Known hypersensitivity to fenofibrate therapy or fibric acid derivatives.

Triglide begins to lower triglyceride levels within several weeks of consistent use. Maximum effects are usually seen after continued daily treatment and adherence to diet therapy. Your healthcare provider will monitor triglyceride levels and overall lipid response during follow-up visits.

When Triglide 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:

• Anticoagulants such as warfarin, which may increase bleeding risk due to enhanced anticoagulant effects. This is because fenofibrate is a CYP2C9 inhibitor. More frequent monitoring may be required.
• Statins may increase the risk of muscle-related side effects when combined. Examples include atorvastatin, rosuvastatin, fluvastatin, and pravastatin.
• Cyclosporine or tacrolimus which may increase the risk of kidney impairment.
• Colchicine may increase the risk of myopathy and rhabdomyolysis.
• Bile acid sequestrants such as cholestyramine or colestipol, which may reduce fenofibrate absorption if taken at the same time.

Triglide tablets were available as 160 mg tablets but have been discontinued.

Other brand-name fenofibrate medications include Tricor and Antara, which contain a different formulation of micronized fenofibrate.

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

Triglide has been discontinued.

There is a generic version of Triglide available.

Do not stop taking Triglide without first speaking to your healthcare provider. Stopping treatment suddenly may cause triglyceride levels to rise again, increasing the risk of complications. Your provider will guide safe discontinuation if needed.

Triglide is generally avoided during pregnancy unless the potential benefit outweighs the risk. 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 fenofibrate passes into breast milk, so caution is advised. 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.