Lofibra 134mg Capsules
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).
Drug Class
Antilipemic agent
Pharmacologic Class
Fibrate; 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 'bad' fats (like triglycerides and LDL cholesterol) and raise 'good' fats (HDL cholesterol) in your blood. It works best when combined with a healthy diet 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 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 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 the same day, 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, 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 the same day, unless your doctor has instructed you to do so.
Lifestyle & Tips
- Follow a low-fat, low-cholesterol diet as recommended by your doctor or dietitian.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Limit alcohol intake, as it can increase triglyceride levels.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
134 mg orally once daily with food
Dose Range:
43 - 134 mg
Condition-Specific Dosing:
severeHypertriglyceridemia:
134 mg orally once daily with food
primaryHypercholesterolemiaOrMixedDyslipidemia:
134 mg orally once daily with food
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment (CrCl 50-80 mL/min)
Moderate:
Reduce dose to 43 mg once daily (CrCl 30-49 mL/min)
Severe:
Contraindicated (CrCl <30 mL/min)
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
Not available
Moderate:
Not available
Severe:
Contraindicated in active liver disease, including primary biliary cirrhosis
Pharmacology
Mechanism of Action
Fenofibric acid, the active metabolite of fenofibrate, activates peroxisome proliferator-activated receptor alpha (PPARΞ±). This activation leads to increased lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III. It also increases the synthesis of apolipoproteins A-I and A-II, leading to increased HDL-C levels.
Pharmacokinetics
Absorption:
Bioavailability:
High (improved with food)
Tmax:
4-5 hours (for fenofibric acid)
FoodEffect:
Absorption is increased by approximately 35% when taken with food. Should be taken with meals.
Distribution:
Vd:
Approximately 30 L (for fenofibric acid)
ProteinBinding:
>99% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20-23 hours (for fenofibric acid)
Clearance:
Not available
ExcretionRoute:
Primarily renal (60-70%) and fecal (25%)
Unchanged:
<5% (fenofibric acid in urine)
Pharmacodynamics
OnsetOfAction:
Within days to weeks
PeakEffect:
Maximal lipid-lowering effects typically observed within 2 months of treatment.
DurationOfAction:
Maintained with continued 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 immediately or seek emergency medical attention:
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 (pancreas problem): 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 unusual or persistent 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 urinating or notice a change in your urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, potentially affecting internal organs. 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. These reactions can be fatal.
Low blood cell counts: If your blood cell counts drop significantly, you may be at risk for bleeding problems, infections, or anemia. Contact your doctor right away if you experience signs of infection, such as fever, chills, or sore throat; unexplained bruising or bleeding; or if you feel extremely tired or weak.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Headache
Back pain
Stomach pain
This is not an exhaustive list of potential 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 notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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 (pancreas problem): 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 unusual or persistent 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 urinating or notice a change in your urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, potentially affecting internal organs. 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. These reactions can be fatal.
Low blood cell counts: If your blood cell counts drop significantly, you may be at risk for bleeding problems, infections, or anemia. Contact your doctor right away if you experience signs of infection, such as fever, chills, or sore throat; unexplained bruising or bleeding; or if you feel extremely tired or weak.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Headache
Back pain
Stomach pain
This is not an exhaustive list of potential 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:
- Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine (signs of muscle breakdown)
- Severe stomach pain, with or without nausea and vomiting (signs of pancreatitis or gallstones)
- Yellowing of your skin or eyes (jaundice), dark urine, or unusual tiredness (signs of liver problems)
- Swelling in your hands or feet
- Signs of an allergic reaction, such as rash, itching, or swelling of the face, lips, or tongue
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 you 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 you 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. 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 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 medication, 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 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 medication, 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:
- No specific antidote. Symptoms of overdose are generally not well-characterized but may include exaggerated 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 symptomatic and supportive. Hemodialysis is not effective in removing fenofibric acid.
Drug Interactions
Contraindicated Interactions
- Cyclosporine (concurrent use with fenofibrate may lead to severe renal dysfunction)
- Statins (increased risk of myopathy/rhabdomyolysis, especially with higher doses or pre-existing renal impairment)
Major Interactions
- Warfarin (potentiates anticoagulant effect, increased risk of bleeding)
- Bile acid sequestrants (e.g., cholestyramine, colestipol, colesevelam - may reduce absorption of fenofibric acid)
- Colchicine (increased risk of myopathy/rhabdomyolysis)
Moderate Interactions
- Other fibrates (e.g., gemfibrozil - increased risk of myopathy/rhabdomyolysis)
- Immunosuppressants (e.g., tacrolimus - potential for increased nephrotoxicity)
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)
Rationale: To assess baseline liver function and monitor for hepatotoxicity.
Timing: Prior to initiation of therapy
Renal Function (Serum Creatinine, eGFR)
Rationale: To assess baseline renal function and guide dosing, as fenofibric acid is primarily renally eliminated.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC)
Rationale: To monitor for potential hematologic abnormalities (e.g., transient decreases in hemoglobin, hematocrit, WBCs).
Timing: Prior to initiation of therapy
Routine Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Frequency: Every 4-8 weeks until lipid goals are achieved, then every 6-12 months
Target: Individualized based on patient risk factors and guidelines
Action Threshold: Consider dose adjustment or alternative therapy if lipid goals are not met after 2 months of therapy.
Liver Function Tests (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then periodically thereafter
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, especially in patients with pre-existing renal impairment or those at risk for renal decline
Target: Stable, within acceptable limits for patient
Action Threshold: Discontinue if significant or progressive increases in serum creatinine are observed.
Complete Blood Count (CBC)
Frequency: Periodically
Target: Within normal limits
Action Threshold: Investigate significant or persistent abnormalities.
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 fatigue or weakness
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.
Trimester-Specific Risks:
First Trimester:
Potential risks not well-established; avoid if possible.
Second Trimester:
Potential risks not well-established; avoid if possible.
Third Trimester:
Potential risks not well-established; avoid if possible.
Lactation
L3 (Moderately Safe). Fenofibric acid is excreted into breast milk. Weigh the developmental and health benefits of breastfeeding against the motherβs clinical need for Lofibra and any potential adverse effects on the breastfed infant or from the underlying maternal condition.
Infant Risk:
Potential for adverse effects on the infant (e.g., gastrointestinal upset, theoretical risk of liver enzyme elevation). Monitor breastfed infants for adverse reactions.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Use with caution in elderly patients due to the increased likelihood of decreased renal function. Dose selection should be cautious, and renal function should be monitored closely.
Clinical Information
Clinical Pearls
- Lofibra (fenofibric acid) should be taken with food to optimize absorption and efficacy.
- This medication is an adjunct to diet and exercise; it is not a substitute for lifestyle modifications.
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, especially if accompanied by fever or malaise, due to the risk of myopathy/rhabdomyolysis.
- Regular monitoring of liver function tests and renal function is crucial during therapy.
- Consider discontinuing therapy if an adequate lipid response is not achieved after 2 months of treatment at the maximum recommended dose.
- Fenofibrates can increase the lithogenicity of bile, potentially leading to gallstone formation. Patients should be monitored for symptoms of cholelithiasis.
Alternative Therapies
- Other Fibrates (e.g., gemfibrozil)
- Statins (e.g., atorvastatin, rosuvastatin, simvastatin)
- Niacin (nicotinic acid)
- Omega-3 Fatty Acids (e.g., icosapent ethyl, omega-3-acid ethyl esters)
- PCSK9 Inhibitors (e.g., evolocumab, alirocumab)
- Ezetimibe
Cost & Coverage
Average Cost:
$100 - $300 per 30 capsules (brand)
Generic Available:
Yes
Insurance Coverage:
Generic fenofibric acid is typically covered as Tier 1 or Tier 2. Brand-name Lofibra may be Tier 3 or require 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 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.