Lipofen 50mg Capsules
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).
Drug Class
Antilipemic agent
Pharmacologic Class
Peroxisome proliferator-activated receptor alpha (PPARΞ±) agonist
Pregnancy Category
Category C
FDA Approved
Jul 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lipofen is a medication used to help lower high levels of 'bad' cholesterol (LDL) and triglycerides, and raise 'good' cholesterol (HDL) in your blood. It works best when combined with a healthy diet and exercise. It's important to take it exactly as prescribed, usually once a day with food.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Check with your pharmacist to see if your specific brand of medication should be taken with food or if it can be taken with or without food.
If you have difficulty swallowing, consult with your doctor for guidance.
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 to feel better.
Important Administration Instructions
Swallow your medication whole. Do not chew, crush, open, or dissolve it.
Storing and Disposing of Your Medication
Store your medication at room temperature with the lid tightly closed.
Some brands of medication require storage in the original container. Do not remove the anti-moisture cube or packet. If you are unsure, consult with 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 instructs you to do so.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Check with your pharmacist to see if your specific brand of medication should be taken with food or if it can be taken with or without food.
If you have difficulty swallowing, consult with your doctor for guidance.
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 to feel better.
Important Administration Instructions
Swallow your medication whole. Do not chew, crush, open, or dissolve it.
Storing and Disposing of Your Medication
Store your medication at room temperature with the lid tightly closed.
Some brands of medication require storage in the original container. Do not remove the anti-moisture cube or packet. If you are unsure, consult with 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 instructs you to do so.
Lifestyle & Tips
- Maintain a heart-healthy diet low in saturated and trans fats, and cholesterol.
- Engage in regular physical activity as recommended by your doctor.
- Achieve and maintain a healthy weight.
- Limit alcohol intake.
- Quit smoking.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For severe hypertriglyceridemia: Initial dose 50 mg once daily with food. For primary hypercholesterolemia or mixed dyslipidemia: 150 mg once daily with food.
Dose Range:
50 - 150 mg
Condition-Specific Dosing:
severeHypertriglyceridemia:
Initial dose 50 mg once daily with food. May be titrated up to 150 mg once daily based on lipid levels and patient response. Maximum dose is 150 mg once daily.
primaryHypercholesterolemiaMixedDyslipidemia:
150 mg once daily with food.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in pediatric patients)
Adolescent:
Not established (safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: No dose adjustment needed for primary hypercholesterolemia or mixed dyslipidemia. For severe hypertriglyceridemia, consider starting at 50 mg once daily and titrate carefully.
Moderate:
CrCl 30-49 mL/min: Reduce dose to 50 mg once daily. Monitor renal function closely.
Severe:
CrCl <30 mL/min: Contraindicated.
Dialysis:
Contraindicated in patients with end-stage renal disease (ESRD) requiring dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment guidance, but use with caution.
Moderate:
Use with caution; monitor liver function closely. Consider lower doses.
Severe:
Contraindicated in patients with active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities.
Pharmacology
Mechanism of Action
Fenofibrate is a peroxisome proliferator-activated receptor alpha (PPARΞ±) agonist. It activates PPARΞ±, which upregulates the expression of genes involved in lipid metabolism, leading to increased lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase (LPL) and reducing production of apolipoprotein C-III (an LPL inhibitor). It also increases the synthesis of apolipoproteins A-I and A-II, which are components of HDL-C, leading to an increase in HDL-C levels. These actions result in reductions in total cholesterol, LDL-C, triglycerides, and VLDL-C, and increases in HDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Increased when taken with food. Lipofen is a micronized formulation designed for improved absorption.
Tmax:
Approximately 4-5 hours for fenofibric acid (active metabolite) after oral administration of Lipofen.
FoodEffect:
Absorption is significantly increased when taken with food. Lipofen should be taken with meals.
Distribution:
Vd:
Not specifically reported for fenofibric acid, but extensively distributed.
ProteinBinding:
Fenofibric acid is approximately 99% bound to plasma proteins, primarily albumin.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20 hours for fenofibric acid.
Clearance:
Primarily renal.
ExcretionRoute:
Mainly urine (approximately 60% as fenofibric acid and its glucuronide conjugate), and feces (approximately 25%).
Unchanged:
Less than 2% of fenofibrate is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Lipid-lowering effects typically begin within days to weeks.
PeakEffect:
Maximal lipid-lowering effects are usually observed within 4-8 weeks of therapy initiation.
DurationOfAction:
Effects persist as long as therapy is continued.
Safety & Warnings
Side Effects
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:
Allergic reactions: 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, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or 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 or eyes, or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience very bad joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, or trouble speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if you feel very tired or weak or have a fever. This can also lead to kidney problems. Inform your doctor if you are unable to pass urine or experience a change in urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be deadly. 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 any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Contact your doctor if you experience signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.
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 any other side effects that bother you or do not go away, contact your doctor:
Headache
Back pain
Stomach pain
This is not an exhaustive list of all 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.
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:
Allergic reactions: 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, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or 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 or eyes, or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience very bad joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, or trouble speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if you feel very tired or weak or have a fever. This can also lead to kidney problems. Inform your doctor if you are unable to pass urine or experience a change in urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be deadly. 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 any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Contact your doctor if you experience signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.
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 any other side effects that bother you or do not go away, contact your doctor:
Headache
Back pain
Stomach pain
This is not an exhaustive list of all 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.
Seek Immediate Medical Attention If You Experience:
- Muscle pain, tenderness, or weakness, especially if accompanied by fever or unusual tiredness (could be a sign of muscle damage).
- Yellowing of your skin or the whites of your eyes (jaundice), dark urine, or pale stools (signs of liver problems).
- Severe stomach pain, with or without nausea and vomiting (could be a sign of pancreatitis or gallstones).
- Unexplained bleeding or bruising (if also taking blood thinners).
- Signs of an allergic reaction like rash, itching, swelling of the face/tongue/throat, severe dizziness, trouble 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, 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 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 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. Do not initiate, stop, or adjust the dosage 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, 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 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 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. Do not initiate, stop, or adjust the dosage 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. Regularly undergo blood work and other laboratory tests 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 in some cases 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 drug, 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.
Be aware that this medication can cause liver problems, which in some cases 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 drug, 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.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported. Symptoms would likely be an exaggeration of known side effects, such as muscle pain, liver enzyme elevations, or gastrointestinal upset.
What to Do:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. Treatment is supportive and symptomatic. Fenofibric acid is not dialyzable.
Drug Interactions
Contraindicated Interactions
- Cyclosporine (increased risk of renal dysfunction)
- Severe renal impairment (CrCl <30 mL/min)
Major Interactions
- Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis. Use with caution, especially at higher statin doses or in patients with predisposing factors.
- Oral anticoagulants (e.g., Warfarin): Potentiates anticoagulant effect, increasing bleeding risk. Requires careful monitoring of INR and dose adjustment of anticoagulant.
- Colchicine: Increased risk of myopathy/rhabdomyolysis when co-administered with fibrates, especially in patients with renal impairment.
Moderate Interactions
- Bile acid sequestrants (e.g., Cholestyramine, Colestipol): May interfere with fenofibrate absorption. Administer fenofibrate at least 1 hour before or 4-6 hours after the sequestrant.
- Fibrates (other): Do not co-administer with other fibrates (e.g., gemfibrozil) due to increased risk of adverse effects, particularly myopathy.
Monitoring
Baseline Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess the need for therapy.
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/CrCl)
Rationale: To assess baseline renal function, as fenofibrate is primarily renally eliminated and requires dose adjustment or is contraindicated in renal impairment.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess baseline hematologic status, as fibrates have been associated with transient decreases in hemoglobin and hematocrit.
Timing: Prior to initiation of therapy.
Routine Monitoring
Lipid Panel
Frequency: Every 4-8 weeks initially, then every 6-12 months once stable.
Target: Individualized based on treatment goals (e.g., LDL-C <100 mg/dL, Triglycerides <150 mg/dL, HDL-C >40 mg/dL).
Action Threshold: If goals not met, consider dose adjustment or alternative therapy. If lipid levels worsen, investigate adherence or other causes.
Liver Function Tests (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then periodically (e.g., annually) thereafter.
Target: Within normal limits.
Action Threshold: If ALT or AST >3 times the upper limit of normal (ULN), discontinue therapy. If elevations are persistent but <3x ULN, monitor more frequently or consider dose reduction/discontinuation.
Renal Function (Serum Creatinine, eGFR/CrCl)
Frequency: Every 3 months during the first year of treatment, then periodically (e.g., annually) thereafter, or more frequently in patients with pre-existing renal impairment or risk factors.
Target: Stable, within acceptable limits for patient's baseline.
Action Threshold: If significant or progressive increase in creatinine, discontinue therapy. Adjust dose for moderate impairment.
Complete Blood Count (CBC)
Frequency: Periodically, especially during the first year.
Target: Within normal limits.
Action Threshold: If significant decrease in hemoglobin or hematocrit, investigate and consider discontinuation.
Creatine Kinase (CK)
Frequency: As needed, if muscle pain, tenderness, or weakness occurs.
Target: Within normal limits.
Action Threshold: If CK levels are significantly elevated (>5x ULN) or if muscle symptoms are severe, discontinue therapy immediately.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
- Dark urine
- Yellowing of skin or eyes (jaundice)
- Severe stomach pain (may indicate pancreatitis or gallstones)
- Nausea, vomiting, loss of appetite
- Unusual fatigue or weakness
- Swelling in hands or feet (edema)
- Signs of bleeding or bruising (if on anticoagulants)
Special Patient Groups
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.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, avoid if possible.
Second Trimester:
Potential for fetal harm, avoid if possible.
Third Trimester:
Potential for fetal harm, avoid if possible.
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:
Risk unknown; potential for serious adverse effects. Generally, avoid use during breastfeeding.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in children.
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
- Lipofen 50mg is a micronized formulation of fenofibrate, designed for improved absorption when taken with food. Always advise patients to take it with their largest meal.
- While 50mg is available, the standard dose for primary hypercholesterolemia or mixed dyslipidemia is 150mg. The 50mg dose is often used as an initial dose for severe hypertriglyceridemia or in patients requiring lower doses due to renal impairment.
- Emphasize the importance of lifestyle modifications (diet, exercise) as an adjunct to fenofibrate therapy.
- Educate patients on symptoms of myopathy (muscle pain, weakness) and liver injury (jaundice, dark urine) and to report them immediately.
- Regular monitoring of liver enzymes and renal function is crucial, especially during the first year of treatment.
- Fenofibrate can increase the risk of gallstones; advise patients to report severe abdominal pain.
- If co-administered with a statin, monitor for muscle symptoms and CK levels more closely. The combination is generally reserved for patients with high cardiovascular risk and persistent dyslipidemia despite statin monotherapy.
Alternative Therapies
- Other fibrates (e.g., Gemfibrozil, Fenofibrate (other formulations like nanocrystallized or conventional))
- Statins (HMG-CoA reductase inhibitors) for LDL-C lowering
- Omega-3 fatty acid ethyl esters for severe hypertriglyceridemia
- PCSK9 inhibitors (for severe hypercholesterolemia)
- Ezetimibe (for LDL-C lowering)
- Bempedoic acid (for LDL-C lowering)
- Nicotinic acid (Niacin) (less commonly used due to side effects)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 30 capsules (for brand Lipofen 50mg)
Generic Available:
Yes
Insurance Coverage:
Generic fenofibrate is typically Tier 1 or 2. Brand Lipofen may be Tier 2 or 3, or require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.