Lofibra 67mg 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 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 reductions in total cholesterol, LDL-C, VLDL-C, and triglycerides, and increases 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 immediately or seek emergency medical attention:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and 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 and eyes, or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience intense joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color change, or pain in a leg or arm, or difficulty speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if accompanied by extreme fatigue, weakness, or fever. Notify your doctor if you experience difficulty urinating or a change in urine output, as this can lead to kidney problems.
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 skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Low blood cell counts: If your blood cell counts drop significantly, you may be at risk for bleeding problems, infections, or anemia. Contact your doctor if you experience:
+ Signs of infection, such as fever, chills, or sore throat
+ Unexplained bruising or bleeding
+ Extreme fatigue or weakness

Other Side Effects

Most people do not experience severe side effects, and some may only have mild or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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. 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 may need to avoid breastfeeding for 5 days after your last dose. Consult your doctor to determine the best course of action.

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 you verify that 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 tests and other laboratory examinations as instructed by your doctor. Adhere to the dietary and exercise plan recommended by your doctor.

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, use this medication with caution, as you may be more susceptible to experiencing side effects.

If you are pregnant or planning to become pregnant, notify your doctor. It is crucial to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.

• Active liver disease (including primary biliary cirrhosis and unexplained persistent liver function abnormalities)
• Severe renal impairment (CrCl < 30 mL/min)
• Pre-existing gallbladder disease

• Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy, rhabdomyolysis, and acute renal failure. Use with caution, especially at higher statin doses. Consider lower doses of both agents and close monitoring.
• Oral anticoagulants (e.g., Warfarin): Potentiates anticoagulant effect, leading to increased INR and risk of bleeding. Reduce anticoagulant dose by one-third and adjust based on INR monitoring.
• Cyclosporine: Can cause reversible renal dysfunction. Monitor renal function closely.

• Bile acid sequestrants (e.g., Cholestyramine, Colestipol, Colesevelam): May reduce absorption of fenofibrate. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid sequestrants.
• Ezetimibe: Increased risk of cholelithiasis and myopathy, though less pronounced than with statins. Monitor for adverse effects.
• Colchicine: Increased risk of myopathy/rhabdomyolysis.

• Not available

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise) - indicative of myopathy/rhabdomyolysis.
• Dark urine - indicative of rhabdomyolysis.
• Yellowing of skin or eyes (jaundice), dark urine, light-colored stools, severe stomach pain, nausea, vomiting, loss of appetite - indicative of liver injury or gallbladder issues.
• Signs of bleeding (unusual bruising, prolonged bleeding from cuts, blood in urine or stools) - if on anticoagulants.

Category C. There are no adequate and well-controlled studies of fenofibrate 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.

L3 (Moderate Concern). It is not known whether fenofibric acid is excreted in human milk. Fenofibrate is excreted in the milk of lactating rats. 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 the higher incidence of decreased renal function in this population. Dose selection should be cautious, usually starting at the low end of the dosing range, and monitoring of renal function is important.

• Lofibra is a nanocrystallized formulation of fenofibrate, which generally allows for more consistent absorption compared to older micronized formulations, even with or without food, though taking with food is often recommended for consistency.
• Fenofibrate is primarily used for severe hypertriglyceridemia (often >500 mg/dL) to reduce the risk of pancreatitis, or as an adjunct to statins for mixed dyslipidemia when triglycerides and HDL-C remain problematic.
• Regular monitoring of liver function tests (ALT, AST) and renal function (CrCl) is crucial due to potential for hepatotoxicity and renal impairment.
• Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, especially if taking a statin concurrently, due to the risk of myopathy/rhabdomyolysis.
• When co-administered with warfarin, fenofibrate can significantly increase INR; close monitoring and warfarin dose adjustment are necessary.
• Fenofibrate can cause reversible increases in serum creatinine, which may not always indicate true renal impairment but warrants monitoring.

• Other fibrates (e.g., Gemfibrozil)
• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin) - often first-line for LDL-C reduction, can also lower triglycerides.
• Omega-3 Fatty Acid Ethyl Esters (e.g., Lovaza, Vascepa) - for severe hypertriglyceridemia.
• PCSK9 inhibitors (e.g., Alirocumab, Evolocumab) - for severe hypercholesterolemia.
• Niacin (Nicotinic Acid) - for dyslipidemia (less commonly used due to side effects).
• Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol, Colesevelam) - for LDL-C reduction.

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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.