Fenofibric 135mg DR Capsules
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).
Drug Class
Antilipemic agent
Pharmacologic Class
Fibric acid derivative; Peroxisome proliferator-activated receptor alpha (PPARΞ±) agonist
Pregnancy Category
Category C
FDA Approved
Dec 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fenofibric acid 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 to improve your lipid levels and reduce the risk of heart 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, take these medications at least 4 hours before or 1 hour after taking this drug.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Swallow the 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 require storage in their 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 instructs 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, take these medications at least 4 hours before or 1 hour after taking this drug.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Swallow the 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 require storage in their 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 instructs you to do so.
Lifestyle & Tips
- 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.
- Maintain a healthy weight.
- Limit alcohol intake, as it can increase triglyceride levels.
- Do not stop taking this medication without consulting your doctor, even if you feel well.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
135 mg orally once daily
Dose Range:
45 - 135 mg
Condition-Specific Dosing:
severeHypertriglyceridemia:
45 mg to 135 mg orally once daily, adjusted to achieve desired triglyceride levels while monitoring for adverse effects.
mixedDyslipidemia:
135 mg orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl 50-80 mL/min).
Moderate:
Reduce dose to 45 mg orally once daily (CrCl 30-49 mL/min).
Severe:
Contraindicated (CrCl < 30 mL/min).
Dialysis:
Contraindicated in patients with end-stage renal disease requiring dialysis.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Use with caution; monitor liver function.
Severe:
Not studied; contraindicated.
Pharmacology
Mechanism of Action
Fenofibric acid, the active metabolite of fenofibrate, is a peroxisome proliferator-activated receptor alpha (PPARΞ±) agonist. It activates PPARΞ±, which in turn upregulates the expression of genes involved in lipid metabolism. This leads to increased lipoprotein lipase (LPL) activity, resulting in enhanced catabolism of triglyceride-rich lipoproteins (VLDL). It also reduces the synthesis of apolipoprotein C-III (an inhibitor of LPL) and increases the synthesis of apolipoproteins A-I and A-II, which are components of HDL-C. The net effect is a reduction in plasma triglycerides and an increase in HDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 81% (for fenofibrate, which is then converted to fenofibric acid)
Tmax:
Approximately 4-5 hours (for fenofibric acid from DR capsules)
FoodEffect:
Increased absorption with food, but the delayed-release formulation can be taken with or without food as systemic exposure is similar.
Distribution:
Vd:
Approximately 30 L (for fenofibric acid)
ProteinBinding:
Greater than 99% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20-23 hours (for fenofibric acid)
Clearance:
Not readily available, primarily renal excretion.
ExcretionRoute:
Primarily renal (60-70% as fenofibric acid and its glucuronide metabolite), with some fecal excretion (25%).
Unchanged:
Less than 2% (of fenofibric acid in urine)
Pharmacodynamics
OnsetOfAction:
Lipid-lowering effects typically observed within 2-4 weeks.
PeakEffect:
Maximal effects on lipids usually seen within 4-8 weeks.
DurationOfAction:
Effects persist as long as therapy is continued, due to long half-life and once-daily dosing.
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, 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.
Pancreas problems (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 have difficulty passing urine or notice a change in your 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 right away if you have signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Headache
Back pain
Stomach pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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, 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.
Pancreas problems (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 have difficulty passing urine or notice a change in your 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 right away if you have signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Headache
Back pain
Stomach pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 signs of muscle damage like rhabdomyolysis).
- Yellowing of your skin or eyes (jaundice), dark urine, light-colored stools, nausea, or vomiting (could be signs of liver problems).
- Severe stomach pain that may spread to your back, with or without nausea and vomiting (could be signs of pancreatitis).
- Signs of kidney problems, such as changes in the amount of urine, swelling in your ankles or feet.
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. 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, 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. 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. Regularly undergo blood work and other laboratory tests as instructed 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, allowing for an informed decision about your care.
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, allowing for an informed decision about your care.
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 muscle pain, liver enzyme elevations, or gastrointestinal upset.
What to Do:
In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive and symptomatic. Hemodialysis is not effective in removing fenofibric acid due to its high protein binding.
Drug Interactions
Contraindicated Interactions
- Gemfibrozil (increased risk of myopathy/rhabdomyolysis)
Major Interactions
- Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy, rhabdomyolysis, and renal failure. Use with caution, monitor for muscle pain.
- Warfarin: Potentiates anticoagulant effect, increasing risk of bleeding. Monitor INR closely.
- Cyclosporine: Increased risk of renal dysfunction. Monitor renal function.
Moderate Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol): May reduce absorption of fenofibric acid. Administer fenofibric acid at least 1 hour before or 4-6 hours after bile acid sequestrants.
- Colchicine: Increased risk of myopathy/rhabdomyolysis when co-administered with fibrates.
Minor Interactions
- Not specifically documented for minor interactions with significant clinical impact.
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)
Rationale: To establish baseline liver function and identify pre-existing hepatic impairment, as fibrates can cause transaminase elevations.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, eGFR)
Rationale: To establish baseline renal function and guide appropriate dosing, as fenofibric acid is primarily renally eliminated.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To establish baseline hematologic parameters, as rare cases of decreased hemoglobin/hematocrit and leukopenia have been reported.
Timing: Prior to initiation of therapy.
Routine Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Frequency: Every 4-8 weeks after initiation or dose change, then periodically (e.g., every 6-12 months) once stable.
Target: Individualized based on treatment goals (e.g., TG < 150 mg/dL, HDL-C > 40 mg/dL).
Action Threshold: If lipid goals are not met after adequate trial, consider dose adjustment or alternative therapy. If paradoxical increase in LDL-C occurs, discontinue.
Liver Function Tests (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then annually.
Target: Within normal limits.
Action Threshold: Discontinue if ALT or AST levels persist at > 3 times the upper limit of normal (ULN) or if symptoms of liver injury develop.
Renal Function (Serum Creatinine, eGFR)
Frequency: Periodically (e.g., annually or more frequently in patients with pre-existing renal impairment or risk factors).
Target: Stable, within acceptable limits for patient's age/condition.
Action Threshold: If significant increase in serum creatinine or decrease in eGFR occurs, consider dose reduction or 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 (> 5 times 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
- Nausea, vomiting, severe abdominal pain (signs of pancreatitis)
- Yellowing of skin or eyes (jaundice)
- Unusual fatigue or weakness
- Loss of appetite
Special Patient Groups
Pregnancy
Fenofibric acid is classified as 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. Lipid-lowering drugs are generally not recommended during pregnancy as cholesterol and cholesterol derivatives are essential for fetal development.
Trimester-Specific Risks:
First Trimester:
Potential risk to fetal development; avoid if possible.
Second Trimester:
Limited data; use only if clearly needed.
Third Trimester:
Limited 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. Monitor the infant for adverse effects.
Infant Risk:
Risk unknown; potential for adverse effects. L3 (moderately safe, but data limited).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
No overall differences in safety or effectiveness were 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
- Fenofibric acid is the active metabolite of fenofibrate, offering consistent exposure. The delayed-release formulation can be taken with or without food.
- Primarily used for severe hypertriglyceridemia and mixed dyslipidemia.
- Crucial to monitor liver function tests (ALT/AST) and renal function (CrCl) regularly, especially during the first year of therapy.
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, as this could indicate myopathy or rhabdomyolysis.
- Avoid concomitant use with gemfibrozil due to increased risk of muscle toxicity.
- Exercise caution when co-administering with statins; the combination increases the risk of muscle adverse events.
- Fenofibric acid can potentiate the effects of warfarin, requiring close INR monitoring and potential dose adjustment of the anticoagulant.
- Not indicated for primary prevention of cardiovascular events, but rather for lipid management in patients with established dyslipidemia.
Alternative Therapies
- Other fibrates (e.g., fenofibrate, gemfibrozil)
- Statins (e.g., atorvastatin, rosuvastatin, simvastatin) for LDL-C lowering and cardiovascular risk reduction
- Omega-3 fatty acid ethyl esters (e.g., icosapent ethyl, omega-3-acid ethyl esters) for severe hypertriglyceridemia
- PCSK9 inhibitors (e.g., evolocumab, alirocumab) for severe hypercholesterolemia
- Niacin (nicotinic acid) for dyslipidemia (less commonly used due to side effects)
- Bile acid sequestrants (e.g., cholestyramine, colesevelam) for LDL-C lowering
Cost & Coverage
Average Cost:
$100 - $300 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 (for brand)
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.