Lofibra 200mg Capsules
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).
Drug Class
Antilipemic Agent, Fibrate
Pharmacologic Class
Peroxisome Proliferator-Activated Receptor Alpha (PPARΞ±) Agonist
Pregnancy Category
Category C
FDA Approved
Mar 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lofibra is a medication used to help lower high levels of triglycerides (a type of fat) in your blood and to increase 'good' cholesterol (HDL). It works by helping your body process fats more effectively. It's often used along with diet changes and exercise.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some formulations of this medication should be taken with food, while others can be taken with or without food. If you're unsure about your specific brand, consult your pharmacist.
If you have difficulty swallowing, discuss this with your doctor. Take your medication with a full glass of water. If you are also taking cholestyramine or colestipol, take these medications at least 4 hours before or 1 hour after your prescribed medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. It's essential to swallow the medication whole, without chewing, crushing, opening, or dissolving it.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping the lid tightly closed. Some brands require storage in the original container, so do not remove the anti-moisture cube or packet. If you're unsure about the storage requirements for your specific brand, consult your doctor or pharmacist.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take more than one dose in a 24-hour period, unless your doctor has instructed you to do so.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some formulations of this medication should be taken with food, while others can be taken with or without food. If you're unsure about your specific brand, consult your pharmacist.
If you have difficulty swallowing, discuss this with your doctor. Take your medication with a full glass of water. If you are also taking cholestyramine or colestipol, take these medications at least 4 hours before or 1 hour after your prescribed medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. It's essential to swallow the medication whole, without chewing, crushing, opening, or dissolving it.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping the lid tightly closed. Some brands require storage in the original container, so do not remove the anti-moisture cube or packet. If you're unsure about the storage requirements for your specific brand, consult your doctor or pharmacist.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take more than one dose in a 24-hour period, unless your doctor has instructed you to do so.
Lifestyle & Tips
- Follow a low-fat, low-cholesterol diet as recommended by your doctor.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Limit alcohol intake.
- Quit smoking.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
200 mg once daily with meals
Dose Range:
67 - 200 mg
Condition-Specific Dosing:
severeHypertriglyceridemia:
200 mg once daily
primaryHypercholesterolemiaOrMixedDyslipidemia:
134 mg once daily, may increase to 200 mg once daily if needed
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: Initiate at 67 mg once daily. Max 67 mg once daily.
Moderate:
CrCl 30-49 mL/min: Initiate at 67 mg once daily. Max 67 mg once daily.
Severe:
CrCl < 30 mL/min: Contraindicated.
Dialysis:
Contraindicated in end-stage renal disease (ESRD) requiring dialysis.
Hepatic Impairment:
Mild:
No specific adjustment, but use with caution.
Moderate:
Contraindicated in active liver disease.
Severe:
Contraindicated in active liver disease.
Pharmacology
Mechanism of Action
Fenofibrate is a prodrug that is rapidly hydrolyzed to its active metabolite, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPARΞ±), a nuclear receptor that regulates lipid metabolism. Activation of PPARΞ± leads to: 1) increased 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); 2) increased synthesis of apolipoproteins A-I and A-II, leading to increased high-density lipoprotein cholesterol (HDL-C) levels; and 3) reduction in very low-density lipoprotein (VLDL) production.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, enhanced by food. Lofibra (micronized fenofibrate) has improved bioavailability compared to conventional formulations.
Tmax:
Approximately 6 to 8 hours for fenofibric acid.
FoodEffect:
Absorption is increased by approximately 35% when taken with food. Lofibra should be taken with meals.
Distribution:
Vd:
Not readily available for fenofibric acid, but extensively distributed.
ProteinBinding:
>99% bound to plasma albumin.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20 to 23 hours for fenofibric acid.
Clearance:
Reduced in renal impairment.
ExcretionRoute:
Primarily renal (approximately 60-90% as fenofibric acid and its glucuronide conjugate); approximately 25% excreted in feces.
Unchanged:
Less than 2% of fenofibric acid is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Lipid-lowering effects typically observed within days to weeks.
PeakEffect:
Maximal effects on lipids usually seen within 4-8 weeks.
DurationOfAction:
Due to long half-life, once-daily dosing maintains therapeutic levels.
Safety & Warnings
Side Effects
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, redness, swelling, blistering, 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 significant 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 changes 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 the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Low blood cell counts: If blood cell counts drop significantly, it can lead to 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 significant side effects, but some may occur. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Headache
Back pain
Stomach pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
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, redness, swelling, blistering, 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 significant 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 changes 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 the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Low blood cell counts: If blood cell counts drop significantly, it can lead to 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 significant side effects, but some may occur. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Headache
Back pain
Stomach pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
Seek Immediate Medical Attention If You Experience:
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or feeling unwell)
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Severe stomach pain (especially if it radiates to your back), with or without nausea and vomiting
- Unusual fatigue or loss of appetite
- Signs of an allergic reaction: rash, hives, swelling of your face, lips, tongue, or throat, difficulty breathing
Before Using This Medicine
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. Be sure to describe the symptoms you experienced.
Certain health conditions, such as:
+ 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 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 conditions 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 your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
Certain health conditions, such as:
+ 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 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 conditions 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.
Precautions & Cautions
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 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, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
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, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Limited information on specific overdose symptoms, but may include exaggerated side effects such as muscle pain, liver enzyme elevations, or gastrointestinal upset.
What to Do:
There is no specific antidote for fenofibrate overdose. Treatment should be symptomatic and supportive. Hemodialysis is not effective in removing fenofibric acid. Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Not explicitly contraindicated with other drugs, but concurrent use with certain agents requires extreme caution or is not recommended.
Major Interactions
- Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy, rhabdomyolysis, and renal failure. Use with caution, especially in patients with pre-existing renal disease or other risk factors for myopathy.
- Oral Anticoagulants (e.g., Warfarin): Potentiates anticoagulant effect by displacing from protein binding sites, leading to increased risk of bleeding. Requires careful monitoring of INR and dose adjustment of anticoagulant.
- Cyclosporine: May cause severe renal dysfunction, including reversible increases in serum creatinine and BUN. Monitor renal function closely.
- Colchicine: Increased risk of myopathy/rhabdomyolysis.
Moderate Interactions
- 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) with co-administration, though the clinical significance is debated.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess treatment efficacy.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST, ALP, Bilirubin)
Rationale: To assess baseline liver function, as fenofibrate can cause transaminase elevations and is contraindicated in active liver disease.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, eGFR)
Rationale: To assess baseline renal function, as fenofibrate is primarily renally eliminated and dose adjustments are required in renal impairment.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess for potential hematologic abnormalities, though rare.
Timing: Prior to initiation of therapy.
Routine Monitoring
Lipid Panel
Frequency: Every 4-8 weeks initially, then periodically (e.g., every 6-12 months) once stable.
Target: Individualized based on patient risk factors and treatment goals (e.g., Triglycerides < 150 mg/dL, HDL-C > 40 mg/dL).
Action Threshold: Lack of desired lipid response after 8-12 weeks, or significant worsening of lipid profile.
Liver Function Tests (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then periodically (e.g., every 6-12 months) thereafter.
Target: Within normal limits.
Action Threshold: Persistent ALT or AST elevations > 3 times the upper limit of normal (ULN) or any signs/symptoms of liver injury (e.g., jaundice, dark urine, abdominal pain) warrant discontinuation.
Renal Function (Serum Creatinine, eGFR)
Frequency: Periodically (e.g., every 6-12 months), or more frequently in patients with pre-existing renal impairment or risk factors.
Target: Stable, within acceptable limits for patient's age and baseline.
Action Threshold: Significant or progressive increase in serum creatinine, or decrease in eGFR, may require dose reduction or discontinuation.
Creatine Kinase (CK)
Frequency: As clinically indicated (e.g., if muscle pain, tenderness, or weakness occurs).
Target: Within normal limits.
Action Threshold: Significant elevation of CK (> 5 times ULN) or symptoms of myopathy/rhabdomyolysis warrant discontinuation.
INR (for patients on Warfarin)
Frequency: More frequently (e.g., daily to weekly) upon initiation or dose change of fenofibrate, then as needed to maintain target INR.
Target: Individualized therapeutic range.
Action Threshold: INR outside of target range requires Warfarin dose adjustment.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
- Signs of liver injury: unusual fatigue, anorexia, right upper quadrant abdominal pain, dark urine, jaundice
- Signs of gallstones: severe abdominal pain, nausea, vomiting
- Signs of pancreatitis: severe abdominal pain radiating to the back, nausea, vomiting
- Signs of allergic reaction: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm cannot be ruled out. Use only if clearly needed.
Second Trimester:
Potential for fetal harm cannot be ruled out. Use only if clearly needed.
Third Trimester:
Potential for fetal harm cannot be ruled out. Use only if clearly needed.
Lactation
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.
Infant Risk:
L3 (Moderately Safe) - Risk unknown, but potential for adverse effects. Monitor infant for adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
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. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Renal function should be monitored.
Clinical Information
Clinical Pearls
- Always take Lofibra with food to optimize absorption and efficacy.
- Fenofibrate is primarily used for severe hypertriglyceridemia and mixed dyslipidemia, not typically as a first-line agent for isolated LDL-C elevation.
- Regular monitoring of liver enzymes and renal function is crucial due to potential for hepatotoxicity and accumulation in renal impairment.
- Counsel patients on the signs and symptoms of myopathy/rhabdomyolysis (muscle pain, weakness) and liver injury, and to report them immediately.
- When switching between different fenofibrate formulations (e.g., Lofibra, Tricor, Fenoglide), be aware of different strengths and bioavailability, as doses are not always directly interchangeable mg-for-mg.
Alternative Therapies
- Other Fibrates (e.g., Gemfibrozil, Bezafibrate)
- Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin) - primarily for LDL-C, but also lower triglycerides
- Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) - for severe hypertriglyceridemia
- PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) - primarily for LDL-C, but can impact triglycerides
- Ezetimibe - for LDL-C
- Niacin (Nicotinic Acid) - for dyslipidemia, but less commonly used due to side effects
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $300+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or 2 for generic fenofibrate; brand-name Lofibra may be Tier 3 or higher, requiring prior authorization.
General Drug Facts
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 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 occurred.