Fenofibrate 150mg Capsules

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 PPARα activation, fenofibric acid increases the synthesis of lipoprotein lipase (LPL) and decreases the synthesis of apolipoprotein C-III (an inhibitor of LPL), leading to enhanced catabolism of triglyceride-rich lipoproteins (VLDL). It also increases the synthesis of apolipoproteins A-I and A-II, which are components of HDL, leading to increased HDL-C levels. The net effect is a reduction in plasma triglycerides and VLDL-C, 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 medical attention immediately:

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.
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: Contact your doctor if you experience very bad 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 deadly. 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 blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Contact your doctor if you have signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.

Other Side Effects

Like all medications, this drug may cause side effects. Many people experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Headache
Back pain
Stomach pain

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Gallbladder disease
+ Kidney disease
+ Liver disease
+ Elevated liver enzymes
If you are taking any of the following medications:
+ Atorvastatin
+ Fluvastatin
+ Lovastatin
+ Pitavastatin
+ Pravastatin
+ Rosuvastatin
+ 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 for personalized guidance.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never 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 experiencing side effects.

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 enable you to make an informed decision about your treatment.

• Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis. Use with caution, especially in patients with predisposing factors for myopathy.
• Oral anticoagulants (e.g., Warfarin): Potentiates anticoagulant effect, increasing risk of bleeding. Monitor INR frequently and adjust anticoagulant dose as needed.
• Cyclosporine: May impair renal function, leading to increased fenofibric acid levels and potential for nephrotoxicity. Monitor renal function closely.
• Colchicine: Increased risk of myopathy/rhabdomyolysis when co-administered with fibrates.

• Bile acid sequestrants (e.g., Cholestyramine, Colestipol): May decrease absorption of fenofibrate. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid sequestrants.
• Ezetimibe: Increased risk of cholelithiasis (gallstones).

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
• Dark urine
• Yellowing of skin or eyes (jaundice)
• Unusual fatigue or weakness
• Abdominal pain (especially right upper quadrant, suggestive of gallstones or pancreatitis)
• Nausea or vomiting
• Easy bruising or bleeding (if on anticoagulants)

Fenofibrate is classified as 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. Animal studies have shown adverse effects on fetal development at doses higher than human therapeutic doses.

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 effectiveness in pediatric patients have not been established. Use is generally not recommended.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Due to the higher incidence of renal impairment in the elderly, dose selection should be cautious, and renal function should be monitored.

• Always take fenofibrate with food to optimize absorption and efficacy.
• Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, especially if accompanied by fever or malaise, due to the risk of myopathy/rhabdomyolysis.
• Regular monitoring of liver function tests (LFTs) and renal function is crucial, particularly during the first year of treatment and in patients with pre-existing renal impairment.
• Fenofibrate is most effective at lowering triglycerides and increasing HDL-C, but it also has a modest effect on lowering LDL-C.
• When co-administered with oral anticoagulants like warfarin, frequent INR monitoring is essential to prevent bleeding complications.
• Fenofibrate is contraindicated in patients with active liver disease, severe renal impairment, or pre-existing gallbladder disease.

• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin) - primarily for LDL-C lowering, but some also lower triglycerides.
• Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) - primarily for severe hypertriglyceridemia.
• Niacin (Nicotinic Acid) - for lowering triglycerides and increasing HDL-C (less commonly used due to side effects).
• PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) - primarily for severe hypercholesterolemia.
• Bempedoic Acid - for LDL-C lowering.
• Diet and lifestyle modifications (cornerstone of lipid management).

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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.