Lofibra

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Lofibra

Quick Facts

Property Description
Active Ingredient Fenofibrate
Form Oral Tablet or Capsule
Pharmacological Class Fibric Acid Derivative (Fibrate)
Primary Action Lipid-regulating agent
Origin Synthetic (Prodrug)

What Type of Drug is Lofibra and What is its Purpose?

Lofibra is a specialized, prescription-only medication chemically classified as an antilipemic agent, or a lipid-regulating agent, which belongs to the fibric acid derivative (fibrate) class of pharmaceuticals. This classification indicates the medicine's role in normalizing abnormal levels of fats (lipids) in the bloodstream, a condition broadly termed dyslipidemia. Drugs like fenofibrate are intended to help improve the lipid profile, addressing high triglycerides and optimizing cholesterol components. This medication is specifically formulated for adult patients and is a single-ingredient product focused entirely on lipid management.

Composition and Origin: The Active Substance Fenofibrate

The active chemical substance contained in Lofibra is fenofibrate (INN), a synthetic small molecule that is provided for oral administration. Fenofibrate is chemically defined as an isopropyl ester of fenofibric acid, confirming its manufactured origin. The drug is presented as a single-ingredient product available in distinct oral tablet and capsule forms. Fenofibrate itself is characterized as a prodrug; it is chemically inactive until the body metabolizes it into its final, therapeutically effective form, fenofibric acid.

The Fundamental Action of a Lipid-Regulating Agent

The mechanism of Lofibra focuses on initiating a key metabolic shift by acting as a Peroxisome Proliferator-Activated Receptor alpha (PPARalpha) agonist. This specific action activates a core cellular regulator that boosts the body’s natural ability to break down fats, primarily through the enhanced activity of the enzyme lipoprotein lipase. This fundamental cellular action directly addresses the core issue of dyslipidemia by increasing lipolysis and promoting the faster clearance of specific fatty substances like triglycerides from the bloodstream. This PPARalpha activation mechanism is characteristic of the fibrate class and underlies its function as a lipid-regulating agent.

Regulatory References

  1. Fenofibrate: MedlinePlus Drug Information

What side effects are possible with Lofibra?

Possible side effects and safety information

The safety profile of Lofibra (fenofibrate) is defined by officially documented adverse reactions classified by frequency and grouped by the physiological systems they affect. The most significant safety concerns, as noted in regulatory documents, relate to the potential for serious adverse reactions affecting the liver and muscles.

Classification Aspect Summary of Regulatory Findings
Hepatotoxicity Risk Potential for drug-induced liver injury (hepatotoxicity) and elevated liver enzymes (transaminases). This can range from moderate increases to rare, serious hepatitis.
Muscle Toxicity Risk Risk of developing myopathy (muscle disorder) and, rarely, severe rhabdomyolysis (skeletal muscle breakdown), a condition documented in regulatory warnings.

Commonly Listed Adverse Reactions

Adverse reactions classified as common in official labeling, occurring in at least 1% to 10% of patients, generally involve Gastrointestinal Disorders (including abdominal pain, nausea, diarrhea, vomiting, and flatulence), headache, and rhinitis. Transient elevations in liver enzymes (ALT/AST) are also frequently noted. Uncommon effects include pancreatitis, cholelithiasis (gallstones), and venous thromboembolism (e.g., Deep Vein Thrombosis).

Safety Restrictions and Contraindications

Lofibra is formally contraindicated in patients with specific pre-existing health conditions due to heightened risk. These include severe renal impairment, active liver disease, and pre-existing gallbladder disease. The medication is also contraindicated in nursing mothers. Safety and effectiveness have not been established for use in pediatric patients. Renal function and liver enzymes require periodic monitoring, as prescribed in regulatory guidelines.

Overdose and Emergency Response

Overdose and When to Seek Help

The official information regarding Lofibra (fenofibrate) overdosage is limited, primarily noting anecdotal cases of gastrointestinal distress, such as nausea or diarrhea. There is no specific antidote known for fenofibrate overdose.

Overdose Management and Emergency Action

Domain Official Regulatory Statement
Documented Manifestations Primarily anecdotal cases of gastrointestinal (GI) distress (nausea, diarrhea).
Population-Specific Note The risk of rhabdomyolysis (severe muscle toxicity) is increased in geriatric patients and those with renal impairment, a critical consideration in high-exposure scenarios.
Emergency Action Required Patients must seek immediate medical attention and/or contact a poison control center. Call emergency services immediately if the individual has collapsed, had a seizure, or has trouble breathing.
Management Protocol Treatment is strictly symptomatic and supportive. Procedures like gastric lavage or emesis may be used to remove unabsorbed drug. Hemodialysis is not effective due to the drug's extensive protein binding.

The regulatory profile centers on immediate clinical assessment and supportive care. Despite limited specific overdose data, regulators mandate immediate help-seeking due to the potential for severe, documented complications like rhabdomyolysis and acute renal failure, which are associated with high exposure. The absence of an antidote and the ineffectiveness of dialysis solidify the focus on prompt supportive management.

Therapeutic Uses of Lofibra

What Lofibra Treats: Main Uses and Benefits

Lofibra is a prescription medication generally used to manage specific metabolic conditions involving abnormal blood fat concentrations, which may be related to systemic imbalance. It is always prescribed as an adjunctive therapy to complement dietary modifications and lifestyle changes when those alone are insufficient.

The medication is commonly used to help with three major categories of lipid abnormality in adult patients. This includes addressing severe hypertriglyceridemia (triglycerides ≥ 500 mg/dL), primary hypercholesterolemia, and mixed dyslipidemia.

Therapeutic Benefits

Lofibra addresses the application of managing specific conditions associated with elevated triglycerides and cholesterol component imbalance. It is used for managing the concentration of these fatty substances, and is considered relevant for easing the heightened systemic burden associated with severe triglyceride elevation.

The medication is relevant for adult patients whose abnormal lipid profile persists, including those with associated conditions like Type 2 Diabetes Mellitus. By providing supportive therapeutic benefit for chronic, elevated lipid levels, Lofibra contributes to easing the overall metabolic burden and assists with maintaining functional stability in the management of chronic, elevated lipid levels.


Quick Fact: Relief for Lipid Abnormalities
Primary Domain Management of Elevated Triglycerides
Symptom Cluster Abnormal Blood Fat Concentrations
Main Benefit Supports the patient in managing the overall lipid profile and easing systemic burden

Eligibility and Restrictions for Use

Who Can and Cannot Use Lofibra? (Fenofibrate)

Lofibra is an approved medication for use in adults to help manage certain lipid levels. However, official regulatory documents state that the drug is contraindicated and must not be used in several specific populations due to the risk of serious complications.

Contraindicated Populations (Must Not Use)

Use of Lofibra is strictly prohibited for individuals with the following conditions or states:

  • Severe Renal Dysfunction: Including patients with end-stage renal disease and those receiving dialysis.
  • Active Liver Disease: This includes individuals with primary biliary cirrhosis or unexplained persistent abnormalities in liver function tests.
  • Pre-existing Gallbladder Disease.
  • Known Hypersensitivity to fenofibrate, fenofibric acid, or any of the inactive ingredients.
  • Nursing Mothers.

Restricted or Limited Use

  • Pediatric Use: Safety and effectiveness have not been established in patients under 18 years of age.
  • Renal Impairment: Patients with mild to moderate renal impairment (e.g., eGFR 30 to 59 mL/min/1.73m^2) require a dose reduction and careful monitoring. The drug is otherwise contraindicated in severe impairment.
  • Pregnancy: Use is generally not recommended unless the potential benefit is determined to justify the potential risk to the fetus.

What should I know about interactions with other medicines?

Lofibra's interaction profile is defined by specific risks and administration requirements documented in regulatory labeling. The co-administration constraints are structured around pharmacodynamic risk management and pharmacokinetic alterations.

Drug–Drug Interactions

Co-administration of Lofibra with other fibric acid derivatives or HMG-CoA reductase inhibitors (Statins) increases the risk of serious muscle toxicity, including myopathy and rhabdomyolysis. This additive risk is officially noted to be increased in geriatric patients and those with renal impairment, diabetes, or uncontrolled hypothyroidism. Fenofibrate also potentiates the anticoagulant effect of Coumarin Anticoagulants (such as Warfarin), resulting in a prolongation of the Prothrombin Time (PT) and INR. This outcome is associated with fenofibric acid's activity as a weak inhibitor of the CYP2C9 enzyme. Cases of myopathy have also been reported with the co-administration of Colchicine. Furthermore, co-administration with certain Immunosuppressants (e.g., Cyclosporine) may pose a risk of reduced fenofibric acid clearance due to potential changes in renal function.

Administration Timing and Absorption

A specific time separation rule exists for co-administration with Bile Acid Binding Resins. Lofibra must be administered at least 1 hour before or 4 to 6 hours after the resin to prevent reduced absorption of fenofibrate. The official labeling notes that administration must occur with food due to a documented drug–food interaction.

Mechanism of Action

PPARalpha Agonism: Gene Regulation of Lipid Metabolism

Lofibra's active metabolite, fenofibric acid, operates by binding to the Peroxisome Proliferator-Activated Receptor Alpha (PPARalpha) within the cell nucleus of liver, muscle, and kidney tissues. This interaction activates PPARalpha, causing it to function as a transcription factor that alters the expression of genes critical for fatty acid catabolism and lipoprotein metabolism.


Enhanced Triglyceride Catabolism and HDL Synthesis

PPARalpha activation initiates a cascade that increases the production of lipoprotein lipase (LPL) and decreases Apolipoprotein C-III (ApoC-III). The increased LPL and reduced inhibition by ApoC-III enhance the breakdown and clearance of triglyceride-rich lipoproteins (such as VLDL and chylomicrons), resulting in decreased plasma triglyceride concentrations. The mechanism simultaneously increases the synthesis of Apolipoprotein A-I (ApoA-I), which raises the concentration and influences the structural maturation of High-Density Lipoprotein (HDL) particles. This system-level modulation alters the circulating lipid profile.

Dosage and Administration Information

How to Use Lofibra: Official Administration Guidelines

Lofibra is an oral medication administered once daily as an adjunct to an appropriate lipid-lowering diet. The dosage depends on the specific lipid condition being addressed and the patient’s clinical status.

Dosing Principles for Adults

For patients with primary hypercholesterolemia or mixed dyslipidemia, the typical dose is 160 mg once daily, while the initial dose for severe hypertriglyceridemia ranges from 54 mg to 160 mg once daily. Dosage is adjusted based on patient response, with repeat lipid determinations generally conducted at 4 to 8 week intervals. Therapy should be discontinued if an adequate response is not achieved after two months of treatment at the maximum recommended dose.

Administration Requirements

Lofibra is available in both tablet and capsule forms, and the official instructions for administration vary by product: while Lofibra tablets (54 mg, 160 mg) can be taken without regard to meals, other fenofibrate capsule formulations may require administration with food to ensure optimal absorption. The dosage unit must be swallowed whole and should not be crushed, broken, or chewed.

Population-Specific Use

For older adults, dose selection is determined by evaluating renal function. Patients who have mild to moderate renal impairment require a lower starting dose, such as 54 mg once daily, which is only increased after assessing the effects on renal function and lipid levels. If a dose is missed, patients are advised not to take an extra dose and should resume treatment with the next regularly scheduled dose.

Recent Clinical Evidence

Research evidence / Overview of Studies for Lofibra (Fenofibrate)


Research Evidence for Severe High Triglycerides

Research examining fenofibrate for managing very high blood fats, specifically severe hypertriglyceridemia (triglycerides ge 500 mg/dL), comes from short-term Randomized Controlled Trials (RCTs). These studies primarily focused on adult patients with high concentrations of triglycerides. Researchers monitored participants over defined time intervals, usually around eight to twelve weeks, to measure the resulting changes in their circulating Triglyceride levels and other related fats like VLDL-C (Very Low-Density Lipoprotein Cholesterol).

Studies described the measured patterns of these specific lipid biomarkers during the study period. Research has examined the measured patterns during the study period, with consistent observations of the triglyceride levels in the observed populations. These findings describe the measured outcomes used to evaluate the medicine within a research setting.


Research Evidence for Mixed Dyslipidemia and High Cholesterol

Research examining fenofibrate for managing mixed dyslipidemia (a combination of high cholesterol and high triglycerides) and primary hypercholesterolemia includes a mix of intermediate-term RCTs and broader systematic reviews. These studies applied in populations of adults presenting with different patterns of abnormal blood lipid concentrations. The content describes the types of changes measured by researchers in the different components of cholesterol, such as LDL-C and HDL-C.

The trials reported patterns observed in the studies, including measurements related to the patient's overall lipid profile. Studies monitored how levels of triglycerides and HDL-C (often called 'good' cholesterol) changed over the observation periods. Evidence contributes to understanding observed patterns and reflects the specific conditions under which these studies were conducted.


Research Evidence for Patients with Type 2 Diabetes Mellitus

For patients with Type 2 Diabetes Mellitus, the evidence landscape includes multiple large-scale, long-term Randomized Controlled Trials (RCTs). These long-duration studies often lasted several years and examined outcomes related to systemic or functional imbalance. Researchers monitored not only lipid biomarkers but also measured clinical events such as Major Cardiovascular Events (MACE) and microvascular complications like the need for certain interventions for diabetic retinopathy (eye disease).

Subgroup Analyses within Major Trials

Further research examined results within specific groups of patients in these large trials, particularly those who started the study with a pattern of high triglycerides and low HDL-C. Findings from these subgroup analyses described patterns related to cardiovascular events for this specific subset of patients. Nevertheless, the research highlights that these subgroup findings are uncertain and require confirmation through dedicated trials focused solely on that particular lipid pattern.

Key Studies & References

  1. Fenofibrate - StatPearls (General overview of indications and use)

Frequently Asked Questions (FAQ)

Common questions about Lofibra (FAQ)


Q: Does Lofibra affect liver enzymes?

Regulatory documents state that transient elevations in liver enzymes (ALT/AST) are frequently observed when using this medication. Because of the potential for liver-related issues, official information indicates that discontinuation of the medication is typically considered if these abnormalities persist or if transaminase levels exceed three times the upper limit of normal.

Q: Is it common to have stomach upset when first starting Lofibra?

Yes, gastrointestinal disorders are among the most commonly listed adverse reactions in official labeling, affecting 1% to 10% of patients in studies. These common effects can include abdominal pain, nausea, diarrhea, vomiting, or flatulence.

Q: How is Lofibra different from other fenofibrate products like Tricor?

Fenofibrate is available in different formulations, and official administration instructions can vary between products. For example, some capsule products like Lofibra are specified to be taken with food, as this condition supports optimal absorption, while some tablet formulations may be taken without regard to meals. Different formulations may also use different dosage strengths.

Q: What is the risk of muscle pain (myopathy) with Lofibra?

Official product information notes a risk of developing muscle disorders, including myopathy (muscle pain or weakness) and, rarely, severe skeletal muscle breakdown called rhabdomyolysis. This risk is known to be increased if the medication is taken alongside statins or other fibrates, or if the patient has other risk factors like kidney issues.

Q: How often do I need blood tests while using Lofibra?

Periodic monitoring of several factors is required. Monitoring requires blood tests to check lipid levels, liver enzymes, and renal function (kidney function). Lipid determinations are typically checked at 4- to 8-week intervals during the initial phase of treatment, and liver and renal function should also be monitored periodically throughout the duration of therapy.

Q: Does Lofibra help with both LDL and HDL cholesterol?

Lofibra is primarily used to address high triglycerides and optimize cholesterol. Official documents describe that fenofibrate treatment typically results in a substantial decrease in triglycerides, a moderate decrease in Low-Density Lipoprotein Cholesterol (LDL-C), and an increase in High-Density Lipoprotein Cholesterol (HDL-C), particularly when the HDL-C level is low at the start of treatment.

Q: What is the long-term effectiveness of Lofibra described as in clinical trials?

While this medication is often used for long-term management, regulatory labeling includes findings from large, long-term clinical trials. For example, studies examining fenofibrate in patients with Type 2 diabetes found that the drug did not reduce coronary heart disease morbidity or mortality.

Q: Is it necessary to follow a strict diet while taking Lofibra?

According to official documentation, Lofibra is only indicated for use as an adjunct to an appropriate lipid-lowering diet. This indicates that patients are expected to be on a suitable diet before starting the medication and should continue that diet throughout the treatment period.

Q: What kind of monitoring is done after starting Lofibra?

Monitoring is key to safe use. It includes periodic checks of your serum lipids, liver function (ALT, AST), and renal function. If muscle symptoms are reported, the healthcare provider may also check creatine phosphokinase (CPK) levels to evaluate for muscle damage.

Q: Are there any food restrictions I need to know about when taking Lofibra?

Official patient information recommends that individuals avoid drinking alcohol before and during treatment. Heavy alcohol use is known to be associated with high triglycerides and may increase the risk of side effects like liver damage and inflammation of the pancreas (pancreatitis).

Q: How quickly does Lofibra start to work to lower cholesterol?

The full effect of the medication is not immediate. To determine if the medication is working, health professionals conduct repeat checks of your lipid levels, usually at 4- to 8-week intervals during the start of therapy. Your dosage is adjusted based on these measured responses.

Q: What happens if I stop taking Lofibra suddenly?

Fenofibrate works to manage fatty substances in the blood only while it is being taken. Regulatory guidance advises patients not to stop taking the medicine without first consulting a healthcare provider, as abrupt discontinuation could lead to a worsening of the lipid profile.

Q: What happens if I accidentally take a Lofibra capsule that is too high of a strength?

In the event of a suspected overdose, the official guidance advises contacting a poison control center or seeking emergency medical attention immediately.

Q: How does Lofibra manage both cholesterol and triglycerides?

The mechanism of action involves activating a cell receptor called PPARalpha. This action increases the breakdown and clearance of triglyceride-rich lipoproteins, which effectively lowers triglycerides. It also increases the production of specific proteins that help raise HDL-C and can lead to a reduction in LDL-C.

Q: Does alcohol consumption affect how Lofibra works?

Yes, official documents recommend avoiding alcohol consumption during treatment. Heavy alcohol use can independently raise triglyceride levels, which may counter the medicine's effect, and can also increase the risk of serious side effects such as liver damage and pancreatitis.

Q: Is there a maximum amount of time someone should be on Lofibra?

Official documents do not set a fixed maximum duration for all patients. However, if the medication is not providing an adequate response to lipid levels after two months of treatment at the maximum recommended dose, the therapy should be discontinued.

Q: Can I take Lofibra if I am lactose intolerant?

Some formulations of Lofibra, such as the tablets, contain lactose monohydrate as an inactive ingredient. Individuals with sensitivities or intolerance to lactose should always inform their prescribing healthcare professional.

Q: Why do official documents mention the risk of pancreatitis with fibrates like Lofibra?

The risk of pancreatitis (inflammation of the pancreas) has been reported in patients using fenofibrate. Official documents state that this may be due to a failure of the medication to control severe high triglycerides, a direct side effect of the drug, or a consequence of gallstones or sludge formation in the biliary tract.

Q: What does official guidance say about Lofibra and kidney stones?

Official regulatory guidance focuses on the risk of gallstones (cholelithiasis), noting that the medication may increase cholesterol in the bile. While the drug is known to reduce serum uric acid levels by increasing excretion, there is no direct, explicit warning regarding an increased risk of kidney stones.

Q: Why is my dose of Lofibra different from someone else's?

Dosage is highly personalized. It is based on the specific condition being treated (e.g., severe high triglycerides versus mixed dyslipidemia), your overall clinical status, and how your body responds to the medication. Dose adjustments are also often made based on an evaluation of your kidney function.

Q: Why is Lofibra sometimes prescribed with a statin?

Despite the increased risk of muscle toxicity when combined with a statin, this combination has been used to manage very severe mixed dyslipidemia, where intense lipid control is needed. While the combination was tested in clinical trials for patients with severe mixed dyslipidemia, findings from some major trials did not show a reduction in cardiovascular morbidity or mortality.

How should Lofibra be stored and disposed of?

Storage and Disposal of Lofibra (Fenofibrate)

Official labeling mandates specific conditions to maintain the quality and stability of Lofibra.


Storage Requirements

Lofibra must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medication is required to be stored in a tight, light-resistant container and must be protected from moisture and excessive heat. For safety, the product must be kept strictly out of reach of children.

Disposal

Unused or expired Lofibra must be properly discarded. Disposal of unused product is required to be handled according to local regulations. Patients are advised to consult a healthcare professional regarding the proper method to dispose of any medicine that is no longer needed or has expired.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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