Lipofen 150mg Capsules
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).
Drug Class
Antilipemic Agents, Fibrates
Pharmacologic Class
Peroxisome Proliferator-Activated Receptor Alpha (PPARΞ±) Agonist
Pregnancy Category
Category C
FDA Approved
Jul 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lipofen is a medication used to help lower high levels of 'bad' fats (triglycerides and LDL cholesterol) and raise 'good' fats (HDL cholesterol) in your blood. It works best when combined with a healthy diet and exercise. Lowering these fats can help reduce your risk of heart disease and other health problems.
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 brands 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, ask your pharmacist for guidance.
If you have difficulty swallowing, discuss this with your doctor. Take your medication with a full glass of water.
If you are taking cholestyramine or colestipol, be sure to take them at least 4 hours before or 1 hour after taking this medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
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 resume 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 brands 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, ask your pharmacist for guidance.
If you have difficulty swallowing, discuss this with your doctor. Take your medication with a full glass of water.
If you are taking cholestyramine or colestipol, be sure to take them at least 4 hours before or 1 hour after taking this medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
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 resume 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
- Take Lipofen exactly as prescribed, usually once daily with a meal to help your body absorb it better.
- Continue to follow a low-fat, low-cholesterol diet as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Limit alcohol intake, as it can increase triglyceride levels.
- Maintain a healthy weight.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
150 mg once daily with meals
Dose Range:
50 - 150 mg
Condition-Specific Dosing:
severeHypertriglyceridemia:
Initial dose 50 mg to 150 mg once daily. Max 150 mg/day.
primaryHypercholesterolemiaOrMixedDyslipidemia:
Initial dose 50 mg to 150 mg once daily. Max 150 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: Reduce dose to 50 mg once daily.
Moderate:
CrCl 30-49 mL/min: Reduce dose to 50 mg every other day.
Severe:
CrCl < 30 mL/min: Contraindicated.
Dialysis:
Contraindicated in patients with severe renal impairment, including those on dialysis.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Use with caution; monitor liver function.
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 prodrug that is rapidly hydrolyzed to its active metabolite, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPARΞ±), which upregulates the expression of genes involved in lipid metabolism. This leads to 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 activity). It also increases the synthesis of apolipoproteins A-I and A-II, leading to increased HDL-C levels.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, enhanced with food (up to 35% increase in exposure with high-fat meal)
Tmax:
6-8 hours (for fenofibric acid)
FoodEffect:
Administration with food significantly increases absorption and bioavailability.
Distribution:
Vd:
Not readily available for fenofibric acid, but extensively distributed.
ProteinBinding:
More than 99% (fenofibric acid to plasma albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20 hours (for fenofibric acid)
Clearance:
Primarily renal clearance of fenofibric acid and its glucuronide conjugate.
ExcretionRoute:
Mainly renal (60-90% as fenofibric acid and its glucuronide conjugate), 2-25% in feces.
Unchanged:
Less than 1% (fenofibric acid)
Pharmacodynamics
OnsetOfAction:
Within days to weeks for lipid-lowering effects.
PeakEffect:
Maximal lipid-lowering effects typically observed within 4-8 weeks of therapy.
DurationOfAction:
Maintained with once-daily dosing due to long half-life.
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 immediate medical attention:
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 nausea and vomiting.
Gallstones: Sudden pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience intense joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, 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, or 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 severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Headache
Back pain
Stomach pain
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit 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 immediate medical attention:
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 nausea and vomiting.
Gallstones: Sudden pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience intense joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, 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, or 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 severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Headache
Back pain
Stomach pain
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Muscle pain, tenderness, or weakness (especially if accompanied by fever or dark urine) β contact your doctor immediately.
- Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain β these could be signs of liver or gallbladder problems.
- Unusual bleeding or bruising (if you are also taking blood thinners).
- Signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or 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. Be sure to describe the symptoms you experienced.
Certain health conditions, such as gallbladder disease, kidney disease, liver disease, or elevated liver enzymes.
If you are taking any of the following medications: atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.
If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication and may need to avoid breastfeeding for 5 days after your last dose. Consult your doctor to determine the best course of action.
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with your existing medications and health conditions.
Do not 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, or elevated liver enzymes.
If you are taking any of the following medications: atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.
If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication and may need to avoid breastfeeding for 5 days after your last dose. Consult your doctor to determine the best course of action.
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with your existing medications and health conditions.
Do not 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. Regularly undergo blood work and other laboratory tests as instructed by your doctor. Adhere to the diet and exercise plan recommended by your doctor to ensure safe and effective use of this medication.
Be aware that liver problems, which can be severe, have been associated with this drug. In rare cases, liver damage has required a liver transplant or resulted 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 side effects.
If you are pregnant or planning to become pregnant, notify your doctor. It is crucial to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
Be aware that liver problems, which can be severe, have been associated with this drug. In rare cases, liver damage has required a liver transplant or resulted 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 side effects.
If you are pregnant or planning to become pregnant, notify your doctor. It is crucial to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
Overdose Information
Overdose Symptoms:
- No specific antidote or symptoms of overdose are known. Symptoms would likely be an exaggeration of known side effects, such as liver enzyme elevations, muscle pain, or gastrointestinal upset.
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment should be symptomatic and supportive. Fenofibric acid is not dialyzable.
Drug Interactions
Major Interactions
- Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy, rhabdomyolysis, and acute 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 the anticoagulant effect, leading to increased risk of bleeding. Requires careful monitoring of INR and dose adjustment of anticoagulant.
- Cyclosporine: May cause reversible renal dysfunction, including increases in serum creatinine and BUN. Monitor renal function closely.
- Colchicine: Increased risk of myopathy/rhabdomyolysis.
Moderate Interactions
- Bile acid resins (e.g., Cholestyramine, Colestipol): May impair absorption of fenofibrate. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid resins.
- Ezetimibe: Potential for increased risk of cholelithiasis (gallstones).
Monitoring
Baseline Monitoring
Fasting 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 and identify pre-existing hepatic impairment. Fibrates can cause reversible increases in transaminases.
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
Fasting Lipid Panel
Frequency: Every 4-8 weeks initially, then every 6-12 months once stable.
Target: Individualized based on treatment goals (e.g., Triglycerides < 150 mg/dL, LDL-C and HDL-C goals per guidelines).
Action Threshold: If lipid goals not met, consider dose adjustment or alternative therapy. If triglycerides remain very high (>500 mg/dL), assess adherence and consider combination therapy.
Liver Function Tests (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then periodically thereafter (e.g., annually) or as clinically indicated.
Target: Within normal limits or stable at slightly elevated baseline.
Action Threshold: If ALT or AST levels exceed 3 times the upper limit of normal (ULN) or if accompanied by symptoms of liver injury, discontinue therapy. If persistent elevations > ULN, consider dose reduction or discontinuation.
Renal Function (Serum Creatinine, eGFR)
Frequency: Periodically (e.g., annually) or as clinically indicated, especially in elderly patients or those with risk factors for renal impairment.
Target: Stable, within normal limits.
Action Threshold: If significant increase in serum creatinine or decrease in eGFR, consider dose adjustment or discontinuation. Contraindicated if CrCl < 30 mL/min.
Creatine Phosphokinase (CPK)
Frequency: As clinically indicated (e.g., if patient reports muscle pain, tenderness, or weakness).
Target: Within normal limits.
Action Threshold: If CPK levels are significantly elevated (e.g., >5 times ULN) or if muscle symptoms are severe, discontinue therapy immediately due to risk of rhabdomyolysis.
International Normalized Ratio (INR) (if on warfarin)
Frequency: More frequently (e.g., weekly) upon initiation or dose change of fenofibrate, then as needed to maintain target INR.
Target: Individualized based on indication for anticoagulation.
Action Threshold: Adjust warfarin dose to maintain target INR.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
- Dark urine
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain (may indicate pancreatitis or gallstones)
- Nausea, vomiting, loss of appetite
- Unusual 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 at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data; avoid if possible.
Second Trimester:
Limited human data; use only if clearly needed.
Third Trimester:
Limited human data; 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. Generally not recommended.
Infant Risk:
Risk level L4 (Potentially Hazardous) - No human data, but animal studies show excretion into milk. Potential for adverse effects in infant.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Use with caution in elderly patients due to the higher incidence of decreased renal function in this population. Renal function should be monitored regularly, and dose adjustments made as necessary.
Clinical Information
Clinical Pearls
- Always take Lipofen with food to optimize absorption and bioavailability.
- Fenofibrate is a prodrug; its active form is fenofibric acid.
- Crucial to monitor liver enzymes and renal function, especially at initiation and during dose adjustments.
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately due to the risk of myopathy/rhabdomyolysis, particularly when co-administered with statins.
- For patients on warfarin, INR monitoring must be intensified when initiating or discontinuing fenofibrate, or changing its dose.
- Not indicated for the treatment of Type I hyperlipoproteinemia (chylomicronemia syndrome) as it may not be effective in this condition.
Alternative Therapies
- Other fibrates (e.g., Gemfibrozil, Clofibrate - less common)
- HMG-CoA reductase inhibitors (Statins - e.g., Atorvastatin, Rosuvastatin) for hypercholesterolemia and mixed dyslipidemia.
- Omega-3 fatty acid ethyl esters (e.g., Lovaza, Vascepa) for severe hypertriglyceridemia.
- PCSK9 inhibitors (e.g., Alirocumab, Evolocumab) for severe hypercholesterolemia.
- Niacin (Nicotinic acid) for dyslipidemia (less commonly used due to side effects).
- Bempedoic acid (Nexletol) or Bempedoic acid/Ezetimibe (Nexlizet) for hypercholesterolemia.
Cost & Coverage
Average Cost:
Varies widely, typically $50-$300+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic fenofibrate); Tier 3 or Non-Formulary (brand Lipofen)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.