Antara

(Fenofibrate Micronized)

The active ingredient in Antara is fenofibrate micronized. The effects of fenofibrate is that it helps the body process fats in the blood more effectively. The pharmacology is that fenofibrate is converted into fenofibric acid, which is the active form in the body. This helps lower triglycerides, very low-density lipoprotein (VLDL) levels, and low-density lipoprotein cholesterol (LDL-C) levels while also helping raise HDL cholesterol (HDL-C) in some patients. Through this mechanism of action, Antara lowers total cholesterol (total-C) and may reduce complications associated with severe hypertriglyceridemia. Fenofibrate therapy is primarily excreted through the urine and feces.

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 Antara. However, the following is a synopsis of the general guidelines for the use of Antara:

• Antara capsules are taken by mouth once daily as a single dose. Swallow the capsule whole. Do not crush, chew, or open it. It can be taken with or without food. The dose will be determined by your healthcare provider.
• Take Antara at the same time each day to help maintain steady levels in your body.
• Continue following your prescribed diet and exercise plan while taking Antara.
• Your healthcare provider may check your lipid levels, liver function, and renal function, like serum creatinine, before and during treatment. This is so your healthcare team will have your baseline level and to monitor changes once you begin therapy.
• Elderly patients (geriatrics) are at increased risk of adverse reactions.
• The effects of Antara have not been shown in pediatrics population.

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

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

Some individuals may experience serious side effects while using Antara. 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.
• Dark-colored urine or decreased 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 signal liver problems.
• Skin rash, hives, or blistering skin reactions, including hypersensitivity reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Signs of an allergic reaction, such as swelling of the face, lips, tongue, or throat.
• Cholelithiasis (gallstones). Fenofibrate can increase cholesterol excretion into the bile.
• Thrombocytopenia and anemia.

These are not all of the possible side effects of Antara. 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 Antara, 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 problems like cirrhosis, hepatic dysfunction, or abnormal liver function tests.
• Kidney problems, renal impairment, or renal failure.
• 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 allergic reactions to fibrates like gemfibrozil.

• Severe renal impairment or end-stage renal disease.
• Active liver disease, including unexplained persistent liver abnormalities.
• Pre-existing gallbladder disease.
• Known hypersensitivity to fenofibrate or any component of the formulation.

Antara begins to affect triglyceride levels within a few weeks of starting treatment. Full effects are usually seen after several weeks of consistent daily use. Your healthcare provider will monitor your lipid levels to assess how well the medication is working and whether dose adjustments are needed.

When Antara 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, may increase bleeding risk due to enhanced anticoagulant effects. This is because fenofibrate is a CYP2C9 inhibitor. Exercise caution in concomitant treatment by monitoring INR more frequently.
• Statins may increase the risk of muscle-related side effects when used together. Examples include simvastatin, atorvastatin, rosuvastatin, and pravastatin.
• Cyclosporine or tacrolimus may increase the risk of kidney problems.
• Colchicine may raise the risk of muscle toxicity when combined.
• Bile acid sequestrants may reduce the absorption of fenofibrate if not taken at separate times.

Antara capsules are available in the following dosage forms: 43 mg capsules and 130 mg capsules. Your prescribed daily dose depends on your triglyceride levels, kidney function, and response to therapy.

Other brand-name fenofibrate medications include Tricor.

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

Antara is manufactured and marketed by Lupin Pharmaceuticals, which produces branded lipid-lowering therapies for cardiovascular risk management.

There is no directly interchangeable generic version of Antara with the same micronized formulation. Other fenofibrate products may be available but are not automatically substitutable.

Do not stop taking Antara without first speaking to your healthcare provider. Stopping treatment suddenly may cause triglyceride levels to rise again. Your provider will guide safe discontinuation if needed.

Antara 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 if 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.