lipofen
Lipofen (Fenofibrate) is a peroxisome proliferator receptor alpha agonist used to treat Coronary Artery Disease, Hypercholesterolemia, Hyperlipoproteinemias, Hypertriglyceridemia.
Fenofibrate · by Cipher Pharms Inc
Available as a generic: Fenofibrate (Micronized)
Key facts
- Active ingredient
- Fenofibrate
- Form
- Capsule
- Strength
- Fenofibrate 100MG · Fenofibrate 150MG · Fenofibrate 50MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Cipher Pharms Inc
- Half-life
- about 20 hours — but that is the half-life of fenofibric acid, the active form, not of fenofibrate itself (how long it stays in your system)
- What the pharmacy pays
- ~$3.45 for 30 — not your price
- FDA application
- NDA021612
What is Lipofen?
From the FDA label:Fenofibrate Capsules USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as hard gelatin capsules for oral administration. Each hard gelatin capsule contains 50 or 150 mg of fenofibrate USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Fenofibrate Capsules USP meet USP Dissolution Test 2. Inactive Ingredients: Each hard gelatin capsule contains Gelucire 44/14 (lauroyl macrogol glyceride type 1500), polyethylene glycol 20,000, polyethylene glycol 8000, hydroxypropylcellulose, sodium starch glycolate, gelatin, titanium dioxide, shellac, propylene glycol, may also contain black iron oxide, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, D&C Yellow #10. Chemical Structure
How to use
Severe hypertriglyceridemia : 50 to 150 mg orally once daily; the dosage should be adjusted according to patient response ( 2.2 ) Primary hyperlipidemia: 150 mg orally once daily ( 2.2 ) Administer as a single dose, at any time of day, with food ( 2.2 ). Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibrate. Discontinue fenofibrate in patients who do not have an adequate response after 2 months of treatment ( 2.2 ) Renal impairment : Initial dosage of 50 mg orally once daily ( 2.3 ) Geriatric patients : Select the dosage on the basis of renal function ( 2.4 ) 2.1 Prior to Initiation of fenofibrate capsules Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high TG levels and manage as appropriate. Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate, and should continue this diet during treatment with fenofibrate. In patients with diabetes and fasting chylomicronemia, improve glycemic control prior to considering starting fenofibrate. 2.2 Recommended Dosage and Administration Severe hypertriglyceridemia: The recommended dosage of fenofibrate capsules is 50 mg or 150 mg orally once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations…
Side effects
The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1) ] Hepatoxicity [see Warnings and Precautions (5.2) ] Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.3) ] Increases in Serum Creatinine [see Warnings and Precautions (5.4) ] Cholelithiasis [see Warnings and Precautions (5.5) ] Increased Bleeding Risk with Coumarin Anticoagulants [see Warnings and Precautions (5.6) ] Pancreatitis [see Warnings and Precautions (5.7) ] Hematologic Changes [see Warnings and Precautions (5.8) ] Hypersensitivity reactions [see Warnings and Precautions (5.9) ] Venothromboembolic disease [see Warnings and Precautions (5.10) ] Paradoxical Decreases in HDL Cholesterol Levels [see Warnings and Precautions (5.11) ] Adverse reactions (≥ 2% and greater than placebo): abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in…
Warnings
Important safety information
Hepatotoxicity : Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrates. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist ( 5.2 ) Myopathy and Rhabdomyolysis : Have been reported in patients taking fenofibrates. Risks are increased during co-administration with a statin, in geriatric patients and in patients with renal impairment, or hypothyroidism. Discontinue fenofibrate if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Temporarily discontinue fenofibrate in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the fenofibrate dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.3 ) Increases in Serum Creatinine : Monitor renal function in patients with renal impairment taking fenofibrate. Consider monitoring renal function in patients at risk for renal impairment. ( 5.4 ) Cholelithiasis : Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. ( 5.5 ) Hypersensitivity Reactions : Acute hypersensitivity reactions, including anaphylaxis and angioedema and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases were life-threatening and required emergency treatment. Discontinue fenofibrate and treat appropriately if reactions occur ( 5.9 ) 5.1 Mortality and Coronary Heart Disease Morbidity Fenofibrate did not reduce cardiovascular disease morbidity or mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Clinical Studies (14.4) ]. Because of chemical, pharmacological, and clinical similarities between fenofibrates, including fenofibrate; pemafibrate; clofibrate; and gemfibrozil; the findings in 5 large randomized, placebo-controlled clinical trials with these other fibrate drugs may also apply to fenofibrate capsules. Pemafibrate did not reduce cardiovascular disease morbidity or mortality in a large, randomized, placebo - controlled trial of patients with type 2 diabetes mellitus on background statin therapy [see Clinical Studies (14.4) ]. In the Coronary Drug Project, a large trial conducted from 1965 to 1985 in men post myocardial infarction, there was no difference in mortality or nonfatal myocardial infarction between the clofibrate group and the placebo group after 5 years of treatment (NCT00000482). In a trial conducted by the World Health Organization (WHO) from 1965 to 1976, men without known coronary artery disease were treated with placebo or clofibrate for 5 years and followed for an additional 1 year. There was a statistically significant, higher age-adjusted all-cause mortality in the clofibrate group compared with the placebo group (5.70% vs. 3.96%, p≤0.01). Excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis. The Helsinki Heart Study, conducted from 1982 to 1987, was a large (n=4,081) trial of middle-aged men without a history of coronary artery disease. Subjects received either placebo or gemfibrozil for 5 years, with a 3.5-year open extension afterward. Total mortality was numerically but not statistically higher in the gemfibrozil randomization group versus placebo [95% confidence interval (CI) of the hazard ratio (HR) 0.91 to 1.64] . A secondary prevention component of the Helsinki Heart Study treated middle-aged men with gemfibrozil or placebo for 5 years. The HR for cardiac deaths was 2.2, 95% CI, 0.94 to 5.05. 5.2 Hepatotoxicity Serious drug-induced liver injury (DILI), including liver transplantation and death, has been reported with postmarketing use of fenofibrates. DILI has been reported within the first few weeks of treatment or after several months of therapy and in some cases has reversed with discontinuation of fenofibrate treatment. Patients with DILI have experienced signs and symptoms including dark urine, abnormal stool, jaundice, malaise, abdominal pain, myalgia, weight loss, pruritus, and nausea. Many patients had concurrent elevations of total bilirubin, serum alanine transaminase (ALT), and aspartate transaminase (AST). DILI has been characterized as hepatocellular, chronic active, and cholestatic hepatitis, and cirrhosis has occurred in association with chronic active hepatitis. In clinical trials, an intermediate daily dosage or the maximum recommended daily dosage of fenofibrate have been associated with increases in serum AST or ALT. The incidence of increases in transaminases may be dose related [see Adverse Reactions (6.1) ] . Fenofibrate capsules are contraindicated in patients with active liver disease, including those with unexplained persistent liver function abnormalities. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy with fenofibrate. Discontinue fenofibrate capsules if signs or symptoms of liver injury develop or if elevated enzyme levels persist (ALT or AST > 3 times the upper limit of normal, or if accompanied by elevation of bilirubin). Do not restart fenofibrate capsules in these patients if there is no alternative explanation for the liver injury. 5.3 Myopathy and Rhabdomyolysis Fenofibrate may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or older, uncontrolled hypothyroidism, renal impairment, and concomitant use with certain other drugs [see Drug Interactions (7) and Use in Specific Populations (8.6) ]. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Data from observational studies indicate that the risk for rhabdomyolysis is increased when fibrates, including fenofibrates, are co-administered with a statin. Avoid concomitant use unless the benefit of further alterations in TG levels is likely to outweigh the increased risk of this drug combination [see Drug Interactions (7) , Clinical Pharmacology (12.3) , and Clinical Studies (14.4) ]. Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates, including fenofibrate capsules, co-administered with colchicine. Consider whether the benefit of using colchicine concomitantly with fenofibrate outweighs the increased risk of myopathy [see Drug Interactions (7) ]. Discontinue fenofibrate if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if fenofibrate is discontinued. Temporarily discontinue fenofibrate in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the fenofibrate dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. 5.4 Increases in Serum Creatinine Increases in serum creatinine have been reported in patients receiving fenofibrates. These increases tend to return to baseline following discontinuation of fenofibrate capsules. The clinical significance of this finding is unknown. Monitor renal function in patients with renal impairment taking fenofibrate…
Who should not take Lipofen
Fenofibrate capsules are contraindicated in patients with: Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology (12.3) ] . Active liver disease, including those with unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2) ] . Pre-existing gallbladder disease [see Warnings and Precautions (5.5) ] . Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate capsules. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate [see Warnings and Precautions (5.9) ] . Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis ( 4 ) Active liver disease, including those with unexplained persistent liver function abnormalities ( 4 ) Pre-existing gallbladder disease ( 4 ) Hypersensitivity to fenofibrate, fenofibric acid, or any of the excipients in fenofibrate capsules ( 4 )
Overdose — what happens if you take too much
In the event of an overdose of fenofibrate, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage, usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Table 2 presents clinically important drug interactions with fenofibrate. Table 2: Clinically Important Drug Interactions with Fenofibrate Statins Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins. Intervention: Consider if the benefit of using fenofibrate concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of statin therapy. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fenofibrates. Intervention: Consider if the benefit of using colchicine concomitantly with fenofibrate outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of colchicine. Coumarin Anticoagulants Clinical Impact: Fibrates may cause potentiation of coumarin-type anticoagulant effects with prolongation of the PT/INR. Intervention: Caution should be exercised when coumarin anticoagulants are given in conjunction with fenofibrate. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized. Immunosuppressants Clinical Impact: Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibrate, there is a risk that an interaction will lead to deterioration of renal function. Intervention: The benefits and risks of using fenofibrate with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dosage employed and renal function monitored. Bile-Acid Binding Resins Clinical Impact: Bile-acid binding resins may bind other drugs given concurrently. Intervention: In patients taking a bile acid resin, administer fenofibrate at least 1 hour before or 4 to 6 hours after the bile acid resin to avoid impeding its absorption. Consider if the benefit of concomitant use of statins or colchicine outweighs the increased risk of myopathy and rhabdomyolysis. Monitor patients for signs and symptoms of myopathy ( 7 ) Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the PT/INR at the desired level to prevent bleeding complications ( 7 ). Consider the benefits and risks of concomitant use with immunosuppressants and other potentially nephrotoxic agents. Use the lowest effective dosage and monitor renal function ( 7 ). Administer fenofibrate at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption ( 7 ).
How long does Fenofibrate stay in your body?
The elimination half-life of fenofibrate is about 20 hours — but that is the half-life of fenofibric acid, the active form, not of fenofibrate itself — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Fenofibrate is a prodrug. The label states it "is a pro-drug of the active chemical moiety fenofibric acid" and that after an oral dose it is "rapidly hydrolyzed by esterases to the active metabolite, fenofibric acid; no unchanged fenofibrate is detected in plasma." So there is no parent half-life to report — the label gives only one figure: "Fenofibric acid is eliminated with a half-life of 20 hours, allowing once daily dosing." That 20 hours is the elimination (terminal) half-life of the active moiety; the label reports no separate distribution phase. Kidney function matters: the label says patients with mild to moderate renal impairment (eGFR 30–59 mL/min/1.73m2) had similar exposure but "an increase in the half-life for fenofibric acid" compared with healthy subjects (it does not say by how much), and severe impairment (eGFR under 30) showed a 2.7-fold increase in exposure with accumulation on chronic dosing — the label says to avoid fenofibrate in severe renal impairment and to reduce the dose in mild-to-moderate. Older adults: in volunteers aged 77–87 the oral clearance of fenofibric acid was 1.2 L/h versus 1.1 L/h in young adults, i.e. essentially unchanged, so no age-related prolongation is described in those with normal renal function. Liver impairment: the label states no pharmacokinetic studies have been conducted in hepatic impairment, so the half-life there is unknown.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: FENOFIBRATE tablet — DailyMed label, §12.3 Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Lipofen ranks — best-rated peroxisome proliferator receptor alpha agonist for:
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Lipofen treat?
- Lipofen (Fenofibrate) may be used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, hypertriglyceridemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Lipofen cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $3.45 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Actos — about $2.77 on the same basis.
- Is there a coupon or discount for Lipofen?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lipofen. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lipofen?
- Lipofen is marketed by Cipher Pharms Inc. You can see Cipher Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Lipofen a brand-name or generic drug?
- Lipofen is a brand-name product with the active ingredient Fenofibrate. Lower-cost generic equivalents containing Fenofibrate are available — ask your pharmacist.
- Is Lipofen available over the counter?
- No. Lipofen is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lipofen come in?
- Lipofen is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Lipofen?
- Lipofen is classified as peroxisome proliferator receptor alpha agonist, per the FDA's Established Pharmacologic Class.
- Is Lipofen FDA-registered?
- Lipofen is on record with the U.S. FDA under application number NDA021612. You can verify this on its official FDA label.
- Has Lipofen been recalled by the FDA?
- Lipofen has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Lipofen safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Lipofen. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Lipofen?
- Lipofen's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1) ] Hepatoxicity [see Warnings and Precautions (5.2) ] Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.3) ] Increas… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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