Fenofibrate 120mg Tablets

Fenofibrate is a prodrug that is rapidly hydrolyzed to its active metabolite, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPARα), a nuclear receptor that regulates lipid metabolism. Through activation of PPARα, fenofibric acid increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III (an inhibitor of lipoprotein lipase activity). It also increases the synthesis of apolipoproteins A-I and A-II, leading to an increase in HDL-C. These effects result in a decrease in total cholesterol, LDL-C, VLDL-C, and triglycerides, and an increase in HDL-C.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Pancreas problems (pancreatitis): Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Gallstones: Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin or eyes, or fever with chills.
Severe joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, or trouble speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if you feel very tired or weak or have a fever. This can also lead to kidney problems. Inform your doctor if you have difficulty urinating or notice a change in your urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: If your blood cell counts become very low, you may be at risk of bleeding problems, infections, or anemia. Contact your doctor right away if you have signs of infection, such as fever, chills, or sore throat; unexplained bruising or bleeding; or if you feel very tired or weak.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only have mild ones. If you are concerned about any of the following side effects or if they persist, contact your doctor:

Headache
Back pain
Stomach pain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
Certain health conditions, such as gallbladder disease, kidney disease, liver disease, or elevated liver enzymes.
If you are taking any of the following medications: atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.
If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication, and you may need to avoid breastfeeding for 5 days after your last dose. Consult your doctor to determine the best course of action.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with all your other medications and health conditions.
Do not start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be conducted as directed by your doctor to monitor your condition. Adhere to the diet and exercise plan recommended by your doctor to ensure optimal management of your health.

Be aware that this medication can cause liver problems, which in some cases may be severe and potentially life-threatening, requiring a liver transplant or resulting in death. If you have any concerns or questions, discuss them with your doctor.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects due to your age.

If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy. This will help you make an informed decision about your care.

• Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy, rhabdomyolysis, and renal failure. Use with caution, especially at higher statin doses.
• Cyclosporine: May impair renal function, leading to increased fenofibric acid exposure and potential for nephrotoxicity. Monitor renal function closely.
• Warfarin and other oral anticoagulants: Potentiates anticoagulant effect, increasing risk of bleeding. Reduce anticoagulant dose and monitor INR frequently.

• Bile acid sequestrants (e.g., cholestyramine, colestipol): May reduce absorption of fenofibrate. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid sequestrants.
• Colchicine: Increased risk of myopathy/rhabdomyolysis when co-administered with fibrates.

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
• Dark urine
• Yellowing of skin or eyes (jaundice)
• Severe abdominal pain
• Unusual fatigue or weakness
• Nausea, vomiting, loss of appetite

Fenofibrate is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether fenofibric acid is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.

Use with caution in elderly patients due to a higher incidence of renal impairment. Monitor renal function closely. Start with the lowest effective dose.

• Fenofibrate should always be taken with food to optimize absorption and bioavailability.
• It is particularly effective for severe hypertriglyceridemia and for increasing HDL-C.
• Monitor liver function tests and renal function regularly, especially during the first year of treatment.
• Counsel patients on the signs and symptoms of myopathy/rhabdomyolysis, especially if co-administered with statins.
• Fenofibrate can cause a reversible increase in serum creatinine, which is generally not indicative of true renal impairment but rather a change in creatinine secretion. However, significant increases warrant investigation.
• Patients on warfarin require close INR monitoring and potential dose reduction of warfarin when initiating or discontinuing fenofibrate.

• Statins (e.g., atorvastatin, rosuvastatin, simvastatin) - primary agents for LDL-C lowering, some TG lowering
• Omega-3 Fatty Acid Esters (e.g., icosapent ethyl, omega-3-acid ethyl esters) - for severe hypertriglyceridemia
• PCSK9 Inhibitors (e.g., evolocumab, alirocumab) - for severe hypercholesterolemia, not primary for TG
• Ezetimibe - for cholesterol absorption inhibition
• Bile Acid Sequestrants (e.g., cholestyramine, colesevelam) - for LDL-C lowering
• Niacin (Nicotinic Acid) - for HDL-C increase and TG lowering (less commonly used due to side effects)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.