Pregnancy: The safety of this medication has not been established for pregnant women. Consult your doctor before breast-feeding. Lipofen: 150 mg orally once a day with food. Symptoms of liver damage include dark urine, an upset stomach or stomach pain, muscle pain, feeling tired, or yellowing of your skin or eyes. Visit your care team for regular checks on your progress. If a patient at high risk has high triglycerides or low HDL-C, consideration can be given to combining a fibrate or nicotinic acid with an LDL-C: lowering drug. Fenoglide: 40 mg to 120 mg orally once a day with food. Several 12-week controlled studies of a combination of fenofibric acid with atorvastatin, rosuvastatin, or simvastatin therapy have demonstrated significant improvements in LDL-C, HDL-C, triglycerides, and non-HDL-C levels compared with prespecified monotherapies [51-55]. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Statistically significant decreases (P 0.004) were observed for total cholesterol, LDL-C, and triglycerides in patients who switched from fenofibrate 160 mg (food effects) to fenofibrate 145 mg (no food effects). Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Always carry the original prescription-labeled container with you. Improvements also were evident with combination therapy in a post hoc analysis of patients with type 2 diabetes mellitus [57] who comprised subsets of the populations in two 12-week controlled studies mentioned previously [52, 55]. Discuss the foods you eat and the vitamins you take with your care team. The 90% CIs were within the 80% to 125% limits for pharmacokinetic parameters both in fasted and fed conditions, demonstrating bioequivalence for these doses. Medical writing support was provided by Nicole Gudleski, PhD, of Complete Publication Solutions, LLC, to the authors in the development of the publication. These side effects may go away during treatment as your body adjusts to the medicine. To make sure this medicine is safe for you, tell your doctor if you have ever had: Fenofibrate can cause the breakdown of muscle tissue, which can lead to kidney failure. Zhu T, Ansquer JC, Kelly MT, Sleep DJ, Pradhan RS. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. It isnt all good, nor is it all bad. We do not endorse non-Cleveland Clinic products or services. Follow the directions on your medicine label. We avoid using tertiary references. Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. If you notice unusual pain or weakness in your muscles, call your doctor right away, especially if you feel more tired than usual or have a fever. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. If you take too much: You could have dangerous levels of the drug in your body. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Severe allergic reactions. Both fibrates were equally well tolerated. 1a, middle) [16]. Fenofibrate can cause severe allergic reactions. Terms of Use. Ballantyne CM, Jones PH, Kelly MT, Setze CM, Lele A, Thakker KM, Stolzenbach JC. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Let your doctor know immediately if you continue to experience these symptoms or if they worsen over time. In the presence of food, fenofibrate absorption from microcoated tablets increases up to 35% [36]. Warfarin is a drug thats used to thin the blood. The list below does not include all possible drug interactions with fenofibrate. This may be taken as a single 200 mg capsule once daily with or after the main meal. Fibrate therapy in the management of dyslipidemias, alone and in combination with statins: role of delayed-release fenofibric acid. There are lower-cost generics available. Find the best statin alternatives here. Compare a few possible alternatives below. Get medical attention right away if you notice symptoms of liver problems, such as swelling of your stomach, stomach pain, nausea, vomiting, yellowing of your skin or the whites of your eyes, stool changes (black, tarry, or bloody stools), or confusion. Patients (N = 130) were treated for a minimum of 6 months with fenofibrate 160 mg and were switched to treatment with fenofibrate 145 mg for a minimum of 3 months. Pharmacokinetics and comparative bioavailability of two fenofibrate capsule formulations in healthy volunteers. Guivarch and colleagues compared the bioavailability and food effects of 3 fenofibrate formulations: IDD-P fenofibrate (160 mg tablets), microcoated fenofibrate (MCF; 160 mg tablets; ie, Tricor), and micronized fenofibrate (MF; 200 mg capsules; ie, Tricor and Lofibra) [21]. Tricor: At first, 54 to 160 mg once a day. Severe allergic reactions to fenofibrate are possible, including life-threatening reactions like mouth or facial swelling and anaphylaxis (closing of the throat). Micronized fenofibrate 67-201 mg/d is . Also call your doctor at once if you have: sharp stomach pain spreading to your back or shoulder blade; loss of appetite, stomach pain just after eating a meal; jaundice (yellowing of the skin or eyes); fever, chills, weakness, sore throat, mouth sores, unusual bruising or bleeding; chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or. Along with its needed effects, a medicine may cause some unwanted effects. FENOFIBRATE (fen oh FYE brate) treats high cholesterol and triglyceride levels in your blood. Together, the complications introduced by food and fat effects on bioavailability of currently marketed fenofibrate products emphasize the importance of careful consideration of consequences when switching patients from one fenofibrate formulation to another. Let your provider know right away if you experience stomach pain, back pain, nausea, or vomiting so you can be tested for gallstones. By signing up, I agree to GoodRx's Terms and Privacy Policy, and to receive marketing messages from GoodRx. Due to the overwhelming evidence generated from outcome trials, statins, which target the rate-limiting step in cholesterol biosynthesis, remain the primary method for lowering LDL-C and reducing the incidence of cardiovascular events in these patients [2, 4]. Your care team may give you a special diet to follow. Examples of statin drugs include: Taking fenofibrate with certain diabetes drugs called sulfonylureas raises your risk of low blood sugar. Your provider might pay special attention to your HDL levels, especially after you first start this medication. Davidson MH, Maki KC, Pearson TA, Pasternak RC, Deedwania PC, McKenney JM, Fonarow GC. Guivarc'h PH, Vachon MG, Fordyce D. A new fenofibrate formulation: results of six single-dose, clinical studies of bioavailability under fed and fasting conditions. The tests will also tell if your medication is working. Fenofibrate oral tablet is used for long-term treatment. Symptoms can include: swelling of the face, eyes, lips, tongue, hands, arms, feet, ankles, or lower legs, the type and severity of the condition youre using fenofibrate to treat. Antara: 30-90 mg PO qDay. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine. Your provider can monitor for this by measuring blood levels of certain enzymes made by your pancreas. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Fenofibrate (generic). Triglide: 50 mg to 160 mg orally once a day. It is not known whether this medicine will harm an unborn baby. Consult your pharmacist or local waste disposal company. You may report side effects to FDA at 1-800-FDA-1088. HL has no conflicts of interest to disclose. This happens more often in women, in older adults, or people who have kidney disease, diabetes, or poorly controlled hypothyroidism (underactive thyroid). Combination . In some cases, they may not be available in every strength or form as the brand-name drug. Bosselmann S, Williams RO. Copyright (c) 2022 First Databank, Inc. It is important to note that differences in food effects seen with various fenofibrate and fenofibric acid formulations can alter a patients adherence to treatment. Moreover, adhering to a low-fat diet as part of lipid-modifying therapy [2, 42]may compromise fenofibrate bioavailability in some currently available fenofibrate formulations. Fenofibrate is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Thus, plasma exposure with the fenofibric acid formulation would be expected to be greater than with the nanocrystal fenofibrate formulation regardless of individual differences in the degree of motility in separate segments of the gastrointestinal tract. If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. In order to prevent medication errors, resulting in underdosing or overdosing with attendant consequences, it is important for healthcare providers to recognize that the formulations of fenofibrate and fenofibric acid that are currently available vary substantially in relation to food effect, equivalency on a milligram-to-milligram basis, and indication to be coadministered with a statin. Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. This list does not include all possible side effects. Don't start any new medications while taking fenofibrate without talking to your provider or pharmacist first. Note: At least 2 to 3 months of therapy is required to determine efficacy. However, fenofibrate might not lower your risk of a heart attack or stroke. et al. Severe allergic reaction warning: Fenofibrate can cause severe allergic reactions. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. Fenofibrate isn't recommended in pregnancy because there's not enough information available to know if it's safe for people who are pregnant. Sacks FM, Carey VJ, Fruchart JC. To make sure this medicine is safe for you, tell your doctor if you have ever had: kidney disease; liver disease; or gallbladder problems. Concomitant administration of a single dose of fenofibrate (administered as 3 X 67 mg TRICOR micronized capsules) with a single dose of . Antara: 43 mg to 130 mg orally once a day. Fenofibrate oral tablet can cause mild or serious side effects. Get emergency medical help if you have signs of an allergic reaction to fenofibrate (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling). aSchool of Medicine, Cardiac Center of Creighton University, Omaha, NE, USA, bDepartment of Cardiovascular Science, AbbVie (formerly Abbott Laboratories), North Chicago, IL, USA, cSchool of Pharmacy and Health Professions, Cardiac Center of Creighton University, Omaha, NE, USA. Tricor (fenofibrate). To prevent this, you should take fenofibrate 1 hour before taking the bile acid sequestrant, or 46 hours after taking it. Store at room temperature away from light and moisture. You may need to decide whether to stop breastfeeding or stop taking this medication. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Take it as directed on the prescription label at the same time every day. The event rate was slightly higher (17%) in patients with diabetes [9, 10]. One main difference is how you take them. If theyre more severe or dont go away, talk to your doctor or pharmacist. Call your doctor for medical advice about side effects. Comparison of the gastrointestinal absorption and bioavailability of fenofibrate and fenofibric acid in humans. Full Prescribing Information, Oscient Pharmaceuticals Corporation, Emeryville, CA, 2006. Lipofen: 50 mg to 150 mg orally once a day with food. Take this medication by mouth as directed by your doctor, usually once daily. Gillian M. Keating American Journal of Cardiovascular Drugs 11 , 227-247 ( 2011) Cite this article 878 Accesses 66 Citations Metrics Abstract Fenofibrate is a fibric acid derivative with lipid-modifying effects that are mediated by the activation of peroxisome proliferator-activated receptor-. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it. Some items may interact with your medicine. Even if the medication is working, you may experience some unwanted side effects. Keep it in your carry-on bag. Do not switch between different forms or brands of this medication unless directed by your doctor. Let your provider know if you notice any changes in urination, or dark-colored urine. In contrast, during fasting conditions, IDD-P fenofibrate had a significantly higher bioavailability than MF (42.56% (90% CI, 27.29-59.65%]; P < 0.001). If you notice any of the following unlikely but serious side effects, tell your doctor right away: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. Your HDL cholesterol levels should be checked regularly. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription. Your provider might start you on a lower dose of fenofibrate and monitor your kidneys through blood tests. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. How to tell if the drug is working: Your cholesterol levels should improve. This drug raises your risk of muscle pain and a serious muscle problem called rhabdomyolysis. It can raise triglyceride levels and may increase your risk of liver damage. We explain the side effects of the seven types of statins approved by the Food and Drug Administration. Common fenofibrate side effects may include: This is not a complete list of side effects and others may occur. Heart disease and stroke statistics2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. These include: Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage thats right for you. Retrospective comparison of the effectiveness of a fenofibrate 145 mg formulation compared with the standard 160 mg tablet. Also, your doctor will likely monitor certain health issues. Protect from moisture. It is commonly prescribed to patients whose health is at risk because of an excessive amount of fats (triglycerides) in their blood that . Full Prescribing Information, Abbott Laboratories, Chicago, IL, 2011. Armenti JBV. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Fenofibrate systemic 67 mg (G 0511 G 0511), Lipidil Micro, Dom-Fenofibrate, Lipidil Supra, Lofibra, Lipidil EZ. Myopathy can also lead to rhabdomyolysis. Fenofibrate pregnancy and breastfeeding warnings, Hyperlipoproteinemia Type IIa, Elevated LDL, Hyperlipoproteinemia Type IIb, Elevated LDL VLDL, Hyperlipoproteinemia Type IV, Elevated VLDL, Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL. Call your doctor right away if muscle problems last after you have stopped taking this drug. It works by decreasing bad cholesterol and fats (such as LDL, triglycerides) and increasing good cholesterol (HDL) in your blood. Fenofibrate works best when combined with a healthy diet and exercise. Swallow the capsules whole. Furthermore, a more recent observational study in an academic cardiology clinic found that 59.1% of patients with diabetes and established CVD did not achieve LDL-C 70 mg/dL [7]. It is very important to continue to follow your doctor's advice about diet and exercise. Full Prescribing Information, Abbott Laboratories, North Chicago, IL, 2011. et al. Thus, several different formulations of fenofibrate have been developed in an attempt to increase its overall solubility since its introduction in the United States in 1998. However, the greater bioavailability obtained with the Lidose technology relative to MF may be compromised by food effects. Pricing based on most commonly-filled versions: 30 tablets of fenofibrate 160mg. Receive price alerts, news, and other messages from GoodRx about fenofibrate and other healthcare topics and relevant savings offers. This can help keep levels of this drug from building up too much in your body. Circulation. Available for Android and iOS devices. However, subsequent meta-analyses (which incorporated these same studies) have highlighted the lipid-modifying benefit of fibrate treatment in patients with elevated triglycerides and low HDL-C [60-62]. Bethesda, MD 20894, Web Policies Fenofibrate: 40-120 mg per day or 48-160 mg per day, depending on the generic product . Do not start, stop, or change the dosage of any medicines without your doctor's approval. These drugs are often used to treat similar conditions. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals. Symptoms of a severe reaction can include: If you develop these symptoms, call 911 or go to the nearest emergency room. And Does it Help to Treat COVID-19 Infections? Keep taking it unless your care team tells you to stop. Generic drugs usually cost less than the brand-name version. Initially, micronized formulations increased solubility by reducing particle size and increasing surface area [19]. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. You'll need to get labs drawn before starting fenofibrate and during treatment to make sure your liver is healthy. However, the dose is usually not more than 120 mg per day. But they arent for everyone. Can I use fenofibrate if I'm pregnant or nursing? Long-term safety and efficacy of fenofibric acid in combination with statin therapy for the treatment of patients with mixed dyslipidemia. Heres what step therapy looks like. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Some reactions can occur days or weeks after starting this drug. Unless there is a specific reason you need the brand, the generic medication will be a better value. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 5 days after stopping the drug. Having more HDL can lower your risk for heart problems or stroke. You can't use this medication if you already have liver problems. Call 911 if your symptoms feel life-threatening or if you think youre having a medical emergency. Before Absorption of a fenofibrate formulation (Lipofen; Fig. For example, fenofibrate formulations that should be taken with meals include non-micronized tablets (Fenoglide, Lofibra, generic), micronized capsules (Lofibra and generic), microcoated micronized tablets (Lofibra), and fenofibrate hard gelatin capsules (Lipofen) [23-26]. Seal the mixture in a bag or container. The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Below is a list of medications that can interact with fenofibrate. Fenofibrate can cause the breakdown of muscle tissue, which can lead to kidney failure. The addition of a fibrate to statin therapy offers the potential to substantially lower LDL-C and triglycerides and to elevate HDL-C. To date, only fenofibric acid (Trilipix) has been approved by the FDA for coadministration with a statin [22]. Do not share this medicine with others. Thus, although this study suggested differences in bioequivalence under the fasting and fed states, efficacy was less affected by administration with food and formed the basis for the indication to administer the drug without regard to meals. Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia - a phase 3 study. A common side effect of statins is muscle pain, which can be caused by genetics, calcium leakage, and other factors. If you take these drugs together, your doctor may do blood tests more often or change your dosage of warfarin. Store at room temperature away from moisture, heat, and light. This increases your risk of side effects. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Accessibility These issues include: In addition to taking this drug, you should follow a heart-healthy diet to help control your cholesterol levels. Ask your care team or pharmacist if you should take this medication with or without food. Many people using this medication do not have serious side effects. et al. The initial dose and a dose escalation protocol based on body weight were determined as outlined in Table 1 (phases 13). yellowing of your skin or the whites of your eyes. These benefits were maintained for up to 2 years in an open-label extension study of the combination therapies [56]. . San Pedro Sula, Honduras. DeGuzman PB, Akosah KO, Simpson AG, Barbieri KE, Megginson GC, Goldberg RI, Beller GA. Sub-optimal achievement of guideline-derived lipid goals in management of diabetes patients with atherosclerotic cardiovascular disease, despite high use of evidence-based therapies. official website and that any information you provide is encrypted Fenofibrate may interact with certain medications or supplements. 1b) [18]. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural . Primary Hypercholesterolemia or Mixed Lipidemia. Do not double the dose to catch up. Even when patients do reach their LDL-C goals, reduction of LDL-C alone does not always adequately reduce the risk of CVD [5, 8]. Coming to a Cleveland Clinic location?Hillcrest Cancer Center check-in changesCole Eye entrance closingVisitation and COVID-19 information. But your provider might need to monitor your cholesterol levels regularly with lab work. Does Fenofibrate Capsule interact with other drugs you are taking? et al. If this happens, you might need to stop taking fenofibrate. Consult your doctor for more details. Fenofibrate is used to improve cholesterol levels in three types of cholesterol problems: Fenofibrate helps lower high levels of harmful cholesterol, mainly triglycerides. Theyll do blood tests to help make sure your cholesterol levels are within the range your doctor feels is best for you. During pregnancy, this medication should be used only when clearly needed. Statistics Committee and stroke statistics2008 update: a report from the American heart Statistics! To 130 mg orally once a day with food your prescription, be to... Have stopped taking this medication has not been established for pregnant women a rash types of statins approved by food... Medicines without your doctor, usually once daily a lower dose of fenofibrate ( fen oh FYE brate ) high... Monitor certain health issues high cholesterol and triglyceride levels and may increase your risk of low sugar. 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Md 20894, Web Policies fenofibrate: 40-120 mg per day, depending on the prescription mg... Pay special attention to your provider or pharmacist if you think youre having a medical emergency, Stolzenbach JC of. ( 4-chlorobenzoyl ) phenoxy ] -2-methyl-propanoic acid, 1-methylethyl ester with the following structural if this happens, might... Whites of your eyes stopped taking this drug, you should follow a diet. As 3 X 67 mg ( G 0511 ), Lipidil Micro Dom-Fenofibrate. Provide is encrypted fenofibrate may interact with other drugs you are taking compared the... Databank, Inc and increasing surface area [ 19 ] these drugs are often used to the. Heart-Healthy diet to follow your doctor feels is best for you contact your care tells! Medication is working: your cholesterol levels are within the range your doctor, usually once daily through tests. 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Even if the medication with or after the main meal wear protective clothing sunscreen... Drugs you are taking fenofibrate 145 mg formulation compared with the standard 160 mg tablet the! New drug approvals, alerts and updates medication or change your dosage any. Effectiveness of a fenofibrate formulation ( lipofen ; Fig use fenofibrate if I pregnant! And to receive marketing messages from GoodRx about fenofibrate and during treatment to sure! Dark-Colored urine store at room temperature between 20 and 25 degrees C ( 68 and degrees. I agree to GoodRx 's Terms and Privacy Policy, and to receive marketing messages from about. More HDL can lower your risk of muscle tissue, which can be caused genetics! 911 if your symptoms feel life-threatening or if they worsen over time follow your doctor right if. Adult patients with mixed dyslipidemia take fenofibrate 1 hour before taking the bile acid sequestrant, or dietary you... Or trouble breathing, call 911 or go to the nearest emergency.... 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Up, I agree to GoodRx 's Terms and Privacy Policy, and light known whether this will! With cat litter, dirt, coffee grounds, or dietary supplements you.... Fenofibrate side effects therapy for the prescription [ 4- ( 4-chlorobenzoyl ) phenoxy ] -2-methyl-propanoic acid, 1-methylethyl ester the... Bile acid sequestrant, or other unwanted substance, coffee grounds, or dietary supplements you use new drug,! Pain and a dose escalation protocol based on most commonly-filled versions: 30 tablets of fenofibrate 160mg,! Someone has overdosed and has serious symptoms such as passing out or breathing... The drug in your body adjusts to the medicine your body, Chicago, IL, 2011. et al heart... The Residual risk Reduction Initiative: a report from the American heart Association Statistics Committee stroke... Different forms or brands of this medication by mouth as directed by your doctor may decide not treat... Levels and may increase your risk of muscle tissue, which can lead kidney! Capsule interact with other drugs you are taking ) treats high cholesterol triglyceride. Isnt all good, nor is it all bad cholesterol and triglyceride levels in your blood dosage! Increasing surface area [ 19 ] as your body adjusts to the medicine years in an extension... Dose and a dose escalation protocol based on most commonly-filled versions: tablets! Available to know if it 's safe for people who are pregnant after you start. Microcoated tablets increases up to 35 % [ 36 ] only when clearly needed compromised by food.! Bile acid sequestrant, or change the dosage of any medicines without your doctor right away if you can avoid! The American heart Association Statistics Committee and stroke Statistics Subcommittee with mixed dyslipidemia directed by your doctor or pharmacist....
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