Fenofibrate 134mg 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. Activation of PPARα leads to: 1) increased synthesis of lipoprotein lipase (LPL), which enhances the catabolism of triglyceride-rich lipoproteins (VLDL); 2) reduced production of apolipoprotein C-III (an inhibitor of LPL); 3) increased synthesis of apolipoproteins A-I and A-II, leading to increased HDL-C levels; and 4) reduced hepatic synthesis of VLDL-C.

Important Side Effects to Report to Your Doctor Right Away

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

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Note: Some allergic reactions can be life-threatening.
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of gallstones, including:
+ Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
Severe joint pain or swelling
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Muscle problems, including:
+ Muscle pain or weakness, especially if accompanied by fever or extreme tiredness
+ Inability to pass urine or changes in urine output
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Low blood cell counts, which can increase the risk of:
+ Infections
+ Bleeding problems
+ Anemia
+ Signs of low blood cell counts include:
- Fever
- Chills
- Sore throat
- Unexplained bruising or bleeding
- Extreme tiredness or weakness

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, or if they bother you or do not go away, 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, such as foods or drugs. Describe the allergic reactions you have 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 conditions 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. Regularly undergo blood work and other laboratory tests as instructed 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 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, monitor for muscle symptoms and CK levels.
• Oral anticoagulants (e.g., Warfarin): Potentiates anticoagulant effect, increasing bleeding risk. Reduce anticoagulant dose and monitor INR frequently.
• Cyclosporine: May impair renal function, leading to increased fenofibric acid levels and potential for renal toxicity. Monitor renal function closely.

• Bile acid sequestrants (e.g., Cholestyramine, Colestipol): May reduce fenofibrate absorption. Administer fenofibrate 1 hour before or 4-6 hours after bile acid sequestrants.
• Colchicine: Increased risk of myopathy/rhabdomyolysis. Use with caution, monitor for muscle symptoms.

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

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 high 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 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 decreased renal function. Monitor renal function closely and consider lower starting doses or dose adjustments based on creatinine clearance.

• Fenofibrate 134mg is a micronized formulation. Ensure patients take it with food to maximize absorption and efficacy.
• Regular monitoring of liver function tests (LFTs) and renal function is crucial, especially during the first year of therapy.
• Educate patients about the signs and symptoms of myopathy/rhabdomyolysis (muscle pain, weakness, dark urine) and advise them to report these immediately.
• Fenofibrate is particularly effective for severe hypertriglyceridemia (TG > 500 mg/dL) to reduce the risk of pancreatitis.
• When co-administering with statins, the risk of muscle toxicity is increased; careful patient selection and monitoring are essential.
• For patients on warfarin, expect to reduce the warfarin dose and monitor INR more frequently upon initiation or discontinuation of fenofibrate.

• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin) - primarily for LDL-C lowering, but some also lower TG.
• Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) - for severe hypertriglyceridemia.
• Niacin (Nicotinic Acid) - for mixed dyslipidemia, but less commonly used due to side effects.
• PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) - primarily for severe hypercholesterolemia.
• Bempedoic Acid - for LDL-C lowering.
• Fibrates (other, e.g., Gemfibrozil) - similar class, but different drug interaction profile and dosing.

If your symptoms or health issues persist or worsen, it is 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 it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.