Drugs Details

Drugs Info of Fibricor, Trilipix
Drugs Details
  • Drugs Type  : Multum
  • Date : 30th Jan 2015 01:29 am
  • Brand Name : Fibricor, Trilipix
  • Generic Name : fenofibric acid (Pronunciation: FEN oh FYE brik AS id)
Descriptions

Trilipix (fenofibric acid) is a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula:

 

Trilipix (fenofibric acid) Structural Formula Illustration

The empirical formula is C22H28CINO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions.

Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hypromellose, povidone, water, hydroxylpropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, black iron oxide, and red iron oxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue #2.

What are the possible side effects of fenofibric acid (Fibricor, Trilipix)?

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking fenofibric acid and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using fenofibric acid and call your doctor at once if you...

Read All Potential Side Effects and See Pictures of Trilipix »

What are the precautions when taking fenofibric acid capsules (Trilipix)?

Before taking fenofibric acid, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: gallbladder disease, liver disease (such as biliary cirrhosis, hepatitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, kidney disease.

Older adults may be more sensitive to the effects of this drug, especially muscle problems.

This...

Read All Potential Precautions of Trilipix »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia

Trilipix is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.

CHD risk equivalents comprise:

  • Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);
  • Diabetes;
  • Multiple risk factors that confer a 10-year risk for CHD > 20%

Treatment of Severe Hypertriglyceridemia

Trilipix is indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Trilipix therapy on reducing this risk has not been adequately studied.

Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia

Trilipix is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Important Limitations of Use

No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.

General Considerations for Treatment

Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Trilipix therapy.

Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.

Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.

Dosage Administration

General Considerations

Patients should be placed on an appropriate lipid-lowering diet before receiving Trilipix as monotherapy or co-administered with a statin, and should continue this diet during treatment. Trilipix delayed release capsules can be taken without regard to meals. Patients should be advised to swallow Trilipix capsules whole. Do not open, crush, dissolve, or chew capsules. Serum lipids should be monitored periodically.

Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia

Trilipix 135 mg may be co-administered with an HMG-CoA reductase inhibitor (statin) in patients with mixed dyslipidemia. For convenience, the daily dose of Trilipix may be taken at the same time as a statin, according to the dosing recommendations for each medication. Co-administration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks.

Severe Hypertriglyceridemia

The initial dose of Trilipix is 45 to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily.

Primary Hypercholesterolemia or Mixed Dyslipidemia

The dose of Trilipix is 135 mg once daily.

Impaired Renal Function

Treatment with Trilipix should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of Trilipix should be avoided in patients with severely impaired renal function [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Geriatric Patients

Dose selection for the elderly should be made on the basis of renal function [see Use In Specific Populations].

How Supplied

Dosage Forms And Strengths

  • 45 mg capsules with a reddish-brown cap imprinted in white ink the Abbott “A” logo and a yellow body imprinted in black ink the number “45”.
  • 135 mg capsules with a blue cap imprinted in white ink the Abbott “A” logo and a yellow body imprinted in black ink the number “135”.

Storage And Handling

Trilipix (fenofibric acid) delayed release capsules 45 mg have a reddish-brown cap imprinted in white ink the Abbott “A” logo and a yellow body imprinted in black ink the number “45”.

Cartons of 30 (NDC 0074-9642-10) and bottles of 90 (NDC 0074-9642-90).

Trilipix (fenofibric acid) delayed release capsules 135 mg have a blue cap imprinted in white ink the Abbott “A” logo and a yellow body imprinted in black ink the number “135”.

Cartons of 30 (NDC 0074-9189-10) and bottles of 90 (NDC 0074-9189-90).

Store at 25°C (77°F); excursions permitted to 15°-30°C (59° to 86°F) [See USP controlled room temperature]. Keep out of the reach of children. Protect from moisture.

Manufactured for Abbott Laboratories, North Chicago, IL 60064, U.S.A. by Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill Co. Cork, Ireland, or Abbott Pharmaceutical PR Ltd., Barceloneta, PR 00617.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse event rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug.

Trilipix (fenofibric acid)

Monotherapy

Treatment-emergent adverse events reported in 3% or more of patients treated with Trilipix during the randomized controlled trials are listed in Table 1 below.

Co-Administration Therapy with Statins (Double-blind Controlled Trials)

Treatment-emergent adverse events reported in 3% or more of patients treated with Trilipix co-administered with statins during the randomized controlled trials are listed in Table 1 below.

Table 1: Treatment-Emergent Adverse Events Reported in ≥ 3% of Patients Receiving Trilipix or Trilipix Co-Administered with a Statin During Double-Blind Controlled Studies [Number (%)]

View Enlarged Table
Co-Administration Therapy with Statins (Long-Term Exposure for up to 64 Weeks')

Patients successfully completing any one of the three double-blind, controlled studies were eligible to participate in a 5 2-week long-term extension study where they received Trilipix co-administered with the moderate dose statin. A total of 2201 patients received at least one dose of Trilipix co-administered with a statin in the double-blind controlled study or the long-term extension study for up to a total of 64 weeks of treatment. Additional treatment-emergent adverse events (not listed in Table 1 above) reported in 3% or more of patients receiving Trilipix co-administered with a statin in either the double-blind controlled studies or the long-term extension study are provided below.

Infections and Infestations

Bronchitis, influenza, and urinary tract infection.

Investigations

AST increased, blood CPK increased, and hepatic enzyme increased.

Musculoskeletal and Connective Tissue Disorders

Musculoskeletal pain.

Psychiatric Disorders

Insomnia.

Respiratory, Thoracic, and Mediastinal Disorders

Cough and pharyngolaryngeal pain.

Vascular Disorders

Hypertension.

Fenofibrate

Fenofibric acid is the active metabolite of fenofibrate. Adverse events reported by 2% or more of patients treated with fenofibrate and greater than placebo during double-blind, placebo-controlled trials are listed in Table 2. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 2. Adverse Events Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM
Adverse Event
Fenofibrate*
(N = 439)
Placebo
(N = 365)
BODY AS A WHOLE
  Abdominal Pain 4.6% 4.4%
  Back Pain 3.4% 2.5%
  Headache 3.2% 2.7%
DIGESTIVE
  Nausea 2.3% 1.9%
  Constipation 2.1% 1.4%
INVESTIGATIONS
  Abnormal Liver Tests 7.5% 1.4%
  Increased AST 3.4% 0.5%
  Increased ALT 3.0% 1.6%
  Increased Creatine Phosphokinase 3.0% 1.4%
RESPIRATORY
  Respiratory Disorder 6.2% 5.5%
  Rhinitis 2.3% 1.1%
* Dosage equivalent to 135 mg Trilipix

Postmarketing Experience

The following adverse events have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, arthralgia, asthenia, and severely depressed HDL-cholesterol levels.

Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

Read the Trilipix (fenofibric acid capsules) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Coumarin Anticoagulants

Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.

Caution should be exercised when oral coumarin anticoagulants are given in conjunction with Trilipix. The dosage of the anticoagulant 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 [see WARNINGS AND PRECAUTIONS].

Bile Acid Binding Resins

Since bile acid binding resins may bind other drugs given concurrently, patients should take Trilipix at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption.

Immunosuppressants

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 drugs of the fibrate class including Trilipix, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using Trilipix with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.

Colchicine

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.

Read the Trilipix Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Mortality and Coronary Heart Disease Morbidity

The effect of Trilipix on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. Because of similarities between Trilipix and fenofibrate, clofibrate, and gemfibrozil, the findings in the following large randomized, placebo-controlled clinical studies with these fibrate drugs may also apply to Trilipix.

The Action to Control Cardiovascular Risk in Diabetes Lipid (ACCORD Lipid) trial was a randomized placebo-controlled study of 5518 patients with type 2 diabetes mellitus on background statin therapy treated with fenofibrate. The mean duration of follow-up was 4.7 years. Fenofibrate plus statin combination therapy showed a non-significant 8% relative risk reduction in the primary outcome of major adverse cardiovascular events (MACE), a composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular disease death (hazard ratio [HR] 0.92, 95% Cl 0.79-1.08) (p=0.32) as compared to statin monotherapy. In a gender subgroup analysis, the hazard ratio for MACE in men receiving combination therapy versus statin monotherapy was 0.82 (95% Cl 0.69-0.99), and the hazard ratio for MACE in women receiving combination therapy versus statin monotherapy was 1.38 (95% Cl 0.98-1.94) (interaction p=0.01). The clinical significance of this subgroup finding is unclear.

The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was a 5-year randomized, placebo-controlled study of 9795 patients with type 2 diabetes mellitus treated with fenofibrate. Fenofibrate demonstrated a non-significant 11% relative reduction in the primary outcome of coronary heart disease events (hazard ratio [HR] 0.89, 95% Cl 0.75-1.05, p = 0.16) and a significant 11% reduction in the secondary outcome of total cardiovascular disease events (HR 0.89 [0.80-0.99], p = 0.04). There was a non-significant 11% (HR 1.11 [0.95, 1.29], p = 0.18) and 19% (HR 1.19 [0.90, 1.57], p = 0.22) increase in total and coronary heart disease mortality, respectively, with fenofibrate as compared to placebo.

In the Coronary Drug Project, a large study of post-myocardial infarction patients treated for 5 years with clofibrate, there was no difference in mortality seen between the clofibrate group and the placebo group. There was, however, a difference in the rate of cholelithiasis and cholecystitis requiring surgery between the two groups (3.0% vs. 1.8%).

In a study conducted by the World Health Organization (WHO), 5000 subjects without known coronary artery disease were treated with placebo or clofibrate for 5 years and followed for an additional one 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. This appeared to confirm the higher risk of gallbladder disease seen in clofibrate-treated patients studied in the Coronary Drug Project.

The Helsinki Heart Study was a large (N = 4081) study 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 higher in the gemfibrozil randomization group but did not achieve statistical significance (p = 0.19, 95% confidence interval for relative risk G:P = 0.91-1.64). Although cancer deaths trended higher in the gemfibrozil group (p = 0.11), cancers (excluding basal cell carcinoma) were diagnosed with equal frequency in both study groups. Due to the limited size of the study, the relative risk of death from any cause was not shown to be different than that seen in the 9 year follow-up data from WHO study (RR = 1.29). A secondary prevention component of the Helsinki Heart Study enrolled middle-aged men excluded from the primary prevention study because of known or suspected coronary heart disease. Subjects received gemfibrozil or placebo for 5 years. Although cardiac deaths trended higher in the gemfibrozil group, this was not statistically significant (hazard ratio 2.2, 95% confidence interval: 0.94-5.05).

Skeletal Muscle

Fibrate and statin monotherapy increase the risk of myositis or myopathy, and have been associated with rhabdomyolysis. Data from observational studies suggest that the risk for rhabdomyolysis is increased when fibrates are co-administered with a statin (with a numerically higher rate observed with gemfibrozil/statin combination use compared to fenofibrate/statin combination use). Refer to the respective statin labeling for important drug-drug interactions that increase statin levels and could increase this risk. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal failure, or hypothyroidism.

In phase 3 clinical trials with Trilipix, myalgia was reported in 3.3% of patients treated with Trilipix monotherapy and 3.1% to 3.5% of patients treated with Trilipix co-administered with statins compared to 4.7% to 6.1% of patients treated with statin monotherapy. Increases in creatine phosphokinase (CPK) to > 5 times upper limit of normal occurred in no patients treated with Trilipix monotherapy and 0.2% to 1.2% of patients treated with Trilipix co-administered with statins compared to 0.4% to 1.3% of patients treated with statin monotherapy.

Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevations of CPK levels. Patients should promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. CPK levels should be assessed in patients reporting these symptoms, and Trilipix and statin therapy should be discontinued if markedly elevated CPK levels occur or myopathy or myositis is suspected or diagnosed.

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine [see DRUG INTERACTIONS].

Liver Function

Trilipix at a dose of 135 mg once daily administered as monotherapy or co-administered with low to moderate doses of statins has been associated with increases in serum transaminases [AST (SGOT) or ALT (SGPT)]. In a pooled analysis of three double-blind controlled studies of Trilipix administered as monotherapy or in combination with statins, increases to > 3 times the upper limit of normal on two consecutive occasions in ALT and AST occurred in 1.9% and 0.2%, respectively, of patients receiving Trilipix monotherapy and in 1.3% and 0.4%, respectively, of patients receiving Trilipix co-administered with statins. Increases to > 3 times the upper limit of normal in ALT and AST occurred in no patients receiving low- to moderate-dose statin monotherapy. Increases to > 3 times the upper limit of normal in ALT and AST occurred in 0.8% and 0.4%, respectively in patients receiving high-dose statin monotherapy. In a long-term study of Trilipix coadministered with statins for up to 52 weeks, increases of > 3 times the upper limit of normal on two consecutive occasions of ALT and AST occurred in 1.2% and 0.5% of patients, respectively. When transaminase determinations were followed either after discontinuation of treatment or during continued treatment, a return to normal limits was usually observed. Increases in ALT and/or AST were not accompanied by increases in bilirubin or clinically significant increases in alkaline phosphatase.

In a pooled analysis of 10 placebo-controlled trials of fenofibrate, increases to > 3 times the upper limit of normal in ALT occurred in 5.3% of patients taking fenofibrate versus 1.1% of patients treated with placebo. The incidence of increases in transaminases observed with fenofibrate therapy may be dose related. In an 8-week dose-ranging study of fenofibrate in hypertriglyceridemia, the incidence of ALT or AST elevations ≥ 3 times the upper limit of normal was 13% in patients receiving dosages equivalent to 90 mg to 135 mg Trilipix once daily and was 0% in those receiving dosages equivalent to 45 mg Trilipix once daily or less, or placebo. Hepatocellular, chronic active, and cholestatic hepatitis observed with fenofibrate therapy have been reported after exposures of weeks to several years. In extremely rare cases, cirrhosis has been reported in association with chronic active hepatitis.

Baseline and regular monitoring of liver function, including serum ALT (SGPT) should be performed for the duration of therapy with Trilipix, and therapy discontinued if enzyme levels persist above 3 times the upper limit of normal.

Serum Creatinine

Reversible elevations in serum creatinine have been reported in patients receiving Trilipix as monotherapy or co-administered with statins as well as patients receiving fenofibrate. In the pooled analysis of three doubleblind controlled studies of Trilipix administered as monotherapy or in combination with statins, increases in creatinine to > 2 mg/dL occurred in 0.8% of patients treated with Trilipix monotherapy and 1.1% to 1.3% of patients treated with Trilipix co-administered with statins compared to 0% to 0.4% of patients treated with statin monotherapy. Elevations in serum creatinine were generally stable over time with no evidence for continued increases in serum creatinine with long-term therapy and tended to return to baseline following discontinuation of treatment. The clinical significance of these observations is unknown. Monitoring renal function in patients with renal impairment taking Trilipix is suggested. Renal monitoring should be considered for patients at risk for renal insufficiency, such as the elderly and those with diabetes.

Cholelithiasis

Trilipix, like fenofibrate, clofibrate, and gemfibrozil, may increase cholesterol excretion into the bile, potentially leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Trilipix therapy should be discontinued if gallstones are found.

Coumarin Anticoagulants

Caution should be exercised when Trilipix is given in conjunction with oral coumarin anticoagulants. Trilipix may potentiate the anticoagulant effects of these agents resulting in prolongation of the prothrombin time/International Normalized Ratio (PT/INR). Frequent monitoring of PT/INR and dose adjustment of the oral anticoagulant are recommended until the PT/INR has stabilized in order to prevent bleeding complications [see DRUG INTERACTIONS].

Pancreatitis

Pancreatitis has been reported in patients taking drugs of the fibrate class, including Trilipix. This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.

Hematological Changes

Mild to moderate hemoglobin, hematocrit, and white blood cell decreases have been observed in patients following initiation of Trilipix and fenofibrate therapy. However, these levels stabilize during long-term administration. Thrombocytopenia and agranulocytosis have been reported in individuals treated with fenofibrates. Periodic monitoring of red and white blood cell counts are recommended during the first 12 months of Trilipix administration.

Hypersensitivity Reactions

Acute hypersensitivity reactions such as Stevens-Johnson syndrome and toxic necrolysis requiring patient hospitalization and treatment with steroids have been reported in individuals treated with fenofibrates.

Venothromboembolic Disease

In the FIELD trial, pulmonary embolus (PE) and deep vein thrombosis (DVT) were observed at higher rates in the fenofibrate- than the placebo-treated group. Of 9,795 patients enrolled in FIELD, there were 4,900 in the placebo group and 4,895 in the fenofibrate group. For DVT, there were 48 events (1%) in the placebo group and 67 (1%) in the fenofibrate group (p = 0.074); and for PE, there were 32 (0.7%) events in the placebo group and 53 (1%) in the fenofibrate group (p = 0.022).

In the Coronary Drug Project, a higher proportion of the clofibrate group experienced definite or suspected fatal or nonfatal PE or thrombophlebitis than the placebo group (5.2% vs. 3.3% at five years; p < 0.01).

Paradoxical Decreases in HDL Cholesterol Levels

There have been postmarketing and clinical trial reports of severe decreases in HDL cholesterol levels (as low as 2 mg/dL) occurring in diabetic and non-diabetic patients initiated on fibrate therapy. The decrease in HDL-C is mirrored by a decrease in apolipoprotein A1. This decrease has been reported to occur within 2 weeks to years after initiation of fibrate therapy. The HDL-C levels remain depressed until fibrate therapy has been withdrawn; the response to withdrawal of fibrate therapy is rapid and sustained. The clinical significance of this decrease in HDL-C is unknown. It is recommended that HDL-C levels be checked within the first few months after initiation of fibrate therapy. If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.

Patient Counseling Information

See Medication Guide

Patient Counseling

Patients should be advised:

  • of the potential benefits and risks of Trilipix.
  • to read the Medication Guide before starting Trilipix therapy and to reread it each time the prescription is renewed.
  • of medications that should not be taken in combination with Trilipix.
  • to continue to follow an appropriate lipid-modifying diet while taking Trilipix.
  • to take Trilipix once daily, without regard to food, at the prescribed dose, swallowing each capsule whole. If Trilipix is co-administered with a statin, they may be taken together.
  • to return for routine monitoring.
  • to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking Trilipix.
  • to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Trilipix (fenofibric acid)

No carcinogenicity and fertility studies have been conducted with choline fenofibrate or fenofibric acid. However, because fenofibrate is rapidly converted to its active metabolite, fenofibric acid, either during or immediately following absorption both in animals and humans, studies conducted with fenofibrate are relevant for the assessment of the toxicity profile of fenofibric acid. A similar toxicity spectrum is expected after treatment with either Trilipix or fenofibrate.

Fenofibrate

Two dietary carcinogenicity studies have been conducted in rats with fenofibrate. In the first 24-month study, Wistar rats were dosed with fenofibrate at 10, 45, and 200 mg/kg/day, approximately 0.3, 1, and 6 times the maximum recommended human dose (MRHD), based on body surface area comparisons (mg/m²). At a dose of 200 mg/kg/day (6 times the MRHD), the incidence of liver carcinomas was significantly increased in both sexes. A statistically significant increase in pancreatic carcinomas was observed in males at 1 and 6 times the MRHD; an increase in pancreatic adenomas and benign testicular interstitial cell tumors was observed at 6 times the MRHD in males. In a second 24-month rat carcinogenicity study in a different strain of rats (Sprague-Dawley), doses of 10 and 60 mg/kg/day (0.3 and 2 times the MRHD), produced significant increases in the incidence of pancreatic acinar adenomas in both sexes and increases in interstitial cell tumors of the testes at 2 times the MRHD.

A 117-week carcinogenicity study was conducted in rats comparing three drugs: fenofibrate 10 and 60 mg/kg/day (0.3 and 2 times the MRHD), clofibrate (400 mg/kg/day; 2 times the human dose), and gemfibrozil (250 mg/kg/day; 2 times the MRHD). Fenofibrate increased pancreatic acinar adenomas in both sexes. Clofibrate increased hepatocellular carcinoma and pancreatic acinar adenomas in males and hepatic neoplastic nodules in females. Gemfibrozil increased hepatic neoplastic nodules in males and females, while all three drugs increased testicular interstitial cell tumors in males.

In a 21-month study in CF-1 mice, fenofibrate 10, 45, and 200 mg/kg/day (approximately 0.2, 1, and 3 times the MRHD on the basis of mg/m² surface area) significantly increased the liver carcinomas in both sexes at 3 times the MRHD. In a second 18-month study at 10, 60, and 200 mg/kg/day, fenofibrate significantly increased the liver carcinomas in male and female mice at 3 times the MRHD.

Electron microscopy studies have demonstrated peroxisomal proliferation following fenofibrate administration to the rat. An adequate study to test for peroxisome proliferation in humans has not been done, but changes in peroxisome morphology and numbers have been observed in humans after treatment with other members of the fibrate class when liver biopsies were compared before and after treatment in the same individual.

Mutagenesis: Fenofibrate has been demonstrated to be devoid of mutagenic potential in the following tests: Ames, and micronucleus in vivo/rat. In addition, fenofibric acid, has been demonstrated to be devoid of mutagenic potential in the following tests: Ames, mouse lymphoma, chromosomal aberration and sister chromatid exchange in human lymphocytes, and unscheduled DNA synthesis in primary rat hepatocytes.

Impairment of Fertility: In a fertility study, rats were given oral dietary doses of fenofibrate. Males received doses for 61 days prior to mating and females for 15 days prior to mating through weaning, which resulted in no adverse effect on fertility at doses up to 300 mg/kg/day (-10 times the MRHD, based on mg/m² surface area comparisons).

Use In Specific Populations

Pregnancy

Pregnancy Category: C

The safety of Trilipix in pregnant women has not been established. There are no adequate and well controlled studies of Trilipix in pregnant women. Trilipix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

When Trilipix is administered with a statin in a woman of childbearing potential, refer to pregnancy category and product labeling for the statin. All statins are contraindicated in pregnant women.

In pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6-15 during the period of organogenesis, adverse developmental findings were not observed at 14 mg/kg/day (less than 1 times the maximum recommended human dose [MRHD], based on body surface area comparisons; mg/m²). At higher multiples of human doses evidence of maternal toxicity was observed.

In pregnant rabbits given oral gavage doses of 15, 150, and 300 mg/kg/day from gestation day 6-18 during the period of organogenesis and allowed to deliver, aborted litters were observed at 150 mg/kg/day (10 times the MRHD, based on body surface area comparisons; mg/m²). No developmental findings were observed at 15 mg/kg/day (at less than 1 times the MRHD, based on body surface area comparisons; mg/m²).

In pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), maternal toxicity was observed at less than 1 times the MRHD, based on body surface area comparisons; mg/m².

Nursing Mothers

Trilipix should not be used in nursing mothers. 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.

Pediatric Use

The safety and effectiveness of Trilipix monotherapy or co-administration with a statin in pediatric patients have not been established.

Geriatric Use

Trilipix is substantially excreted by the kidney as fenofibric acid and fenofibric acid glucuronide, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Fenofibric acid exposure is not influenced by age. Since elderly patients have a higher incidence of renal impairment, dose selection for the elderly should be made on the basis of renal function [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY]. Elderly patients with normal renal function should require no dose modifications. Consider monitoring renal function in elderly patients taking Trilipix.

Renal Impairment

The use of Trilipix should be avoided in patients who have severe renal impairment [see CONTRAINDICATIONS]. Dose reduction is required in patients with mild to moderate renal impairment [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY]. Monitoring renal function in patients with renal impairment is recommended.

Hepatic Impairment

The use of Trilipix has not been evaluated in subjects with hepatic impairment [see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY].

This monograph has been modified to include the generic and brand name in many instances.

OverDose

There is no specific treatment for overdose with Trilipix. 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 Trilipix is highly bound to plasma proteins, hemodialysis should not be considered.

ContrainDications

Trilipix is contraindicated in:

  • patients with severe renal impairment, including those receiving dialysis [see CLINICAL PHARMACOLOGY].
  • patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see WARNINGS AND PRECAUTIONS].
  • patients with preexisting gallbladder disease [see WARNINGS AND PRECAUTIONS].
  • nursing mothers [see Use In Specific Populations].
  • patients with hypersensitivity to fenofibric acid or fenofibrate [see WARNINGS AND PRECAUTIONS].

When Trilipix is co-administered with a statin, refer to the Contraindications section of the respective statin labeling.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

The active moiety of Trilipix is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate.

The lipid-modifying effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α (PPARα). Through this mechanism, fenofibric acid increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of Apo CIII (an inhibitor of lipoprotein lipase activity).

The resulting decrease in TG produces an alteration in the size and composition of LDL from small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly. Activation of PPARα also induces an increase in the synthesis of HDL-C and Apo AI and AIL

Pharmacodynamics

Elevated levels of Total-C, LDL-C, and Apo B, and decreased levels of HDL-C and its transport complex,

Apo AI and Apo All, are risk factors for human atherosclerosis. Epidemiologic studies have established that cardiovascular morbidity and mortality vary directly with the levels of Total-C, LDL-C, and TG, and inversely with the level of HDL-C. The independent effect of raising HDL-C or lowering TG on the risk of cardiovascular morbidity and mortality has not been determined.

Fenofibric acid, the active metabolite of fenofibrate, produces reductions in TC, LDL-C, Apo B, TG, and triglyceride-rich lipoprotein (VLDL) in treated patients. In addition, treatment with fenofibric acid results in increases in HDL-C and Apo AI and Apo AIL

Pharmacokinetics

Trilipix contains fenofibric acid, which is the only circulating pharmacologically active moiety in plasma after oral administration of Trilipix. Fenofibric acid is also the circulating pharmacologically active moiety in plasma after oral administration of fenofibrate, the ester of fenofibric acid.

Plasma concentrations of fenofibric acid after administration of one 135 mg Trilipix delayed release capsule are equivalent to those after one 200 mg capsule of micronized fenofibrate administered under fed conditions.

Absorption

Fenofibric acid is well absorbed throughout the gastrointestinal tract. The absolute bioavailability of fenofibric acid is approximately 81%.

Peak plasma levels of fenofibric acid occur within 4 to 5 hours after a single dose administration of Trilipix capsule under fasting conditions.

Fenofibric acid exposure in plasma, as measured by Cmax and AUC, is not significantly different when a single 135 mg dose of Trilipix is administered under fasting or nonfasting conditions.

Distribution

Upon multiple dosing of Trilipix, fenofibric acid levels reach steady state within 8 days. Plasma concentrations of fenofibric acid at steady state are approximately slightly more than double those following a single dose. Serum protein binding is approximately 99% in normal and dyslipidemic subjects.

Metabolism

Fenofibric acid is primarily conjugated with glucuronic acid and then excreted in urine. A small amount of fenofibric acid is reduced at the carbonyl moiety to a benzhydrol metabolite which is, in turn, conjugated with glucuronic acid and excreted in urine.

In vivo metabolism data after fenofibrate administration indicate that fenofibric acid does not undergo oxidative metabolism (e.g., cytochrome P450) to a significant extent.

Elimination

After absorption, Trilipix is primarily excreted in the urine in the form of fenofibric acid and fenofibric acid glucuronide.

Fenofibric acid is eliminated with a half-life of approximately 20 hours, allowing once daily administration of Trilipix.

Specific Populations

Geriatrics

In five elderly volunteers 77 to 87 years of age, the oral clearance of fenofibric acid following a single oral dose of fenofibrate was 1.2 L/h, which compares to 1.1 L/h in young adults. This indicates that an equivalent dose of Trilipix can be used in elderly subjects with normal renal function, without increasing accumulation of the drug or metabolites [see Use in Specific Populations].

Pediatrics

The pharmacokinetics of Trilipix has not been studied in pediatric populations.

Gender

No pharmacokinetic difference between males and females has been observed for Trilipix.

Race

The influence of race on the pharmacokinetics of Trilipix has not been studied; however, fenofibric acid is not metabolized by enzymes known for exhibiting inter-ethnic variability.

Renal Impairment

The pharmacokinetics of fenofibric acid was examined in patients with mild, moderate, and severe renal impairment. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m²) showed a 2.7-fold increase in exposure for fenofibric acid and increased accumulation of fenofibric acid during chronic dosing compared to that of healthy subjects. 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 to that of healthy subjects. Based on these findings, the use of Trilipix should be avoided in patients who have severe renal impairment and dose reduction is required in patients having mild to moderate renal impairment [see DOSAGE AND ADMINISTRATION].

Hepatic Impairment

No pharmacokinetic studies have been conducted in patients with hepatic impairment.

Drug-drug Interactions

In vitro studies using human liver microsomes indicate that fenofibric acid is not an inhibitor of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. It is a weak inhibitor of CYP2C8, CYP2C19, and CYP2A6, and mild-to-moderate inhibitor of CYP2C9 at therapeutic concentrations.

Comparison of atorvastatin exposures when atorvastatin (80 mg once daily for 10 days) is given in combination with fenofibric acid (Trilipix 135 mg once daily for 10 days) and ezetimibe (10 mg once daily for 10 days) versus when atorvastatin is given in combination with ezetimibe only (ezetimibe 10 mg once daily and atorvastatin, 80 mg once daily for 10 days): The Cmax decreased by 1% for atorvastatin and ortho-hydroxy-atorvastatin and increased by 2% for parahydroxy-atorvastatin. The AUC decreased 6% and 9% for atorvastatin and orthohydroxy-atorvastatin, respectively, and did not change for para-hydroxy-atorvastatin.

Comparison of ezetimibe exposures when ezetimibe (10 mg once daily for 10 days) is given in combination with fenofibric acid (Trilipix 135 mg once daily for 10 days) and atorvastatin (80 mg once daily for 10 days) versus when ezetimibe is given in combination with atorvastatin only (ezetimibe 10 mg once daily and atorvastatin, 80 mg once daily for 10 days): The Cmax increased by 26% and 7% for total and free ezetimibe, respectively. The AUC increased by 27% and 12% for total and free ezetimibe, respectively.

Table 3 describes the effects of co-administered drugs on fenofibric acid systemic exposure. Table 4 describes the effects of co-administered fenofibric acid on other drugs.

Table 3: Effects of Co-Administered Drugs on Fenofibric Acid Systemic Exposure from Trilipix or Fenofibrate Administration

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Table 4: Effects of Trilipix or Fenofibrate Co-Administration on Systemic Exposure of Other Drugs

View Enlarged Table

Clinical Studies

Co-Administration Therapy with Statins

Efficacy and safety of Trilipix co-administered with statins were assessed in three 12-week, double-blind, controlled Phase 3 studies and one 52-week, long-term, open-label extension study in 2698 patients with mixed dyslipidemia. Patients were required to meet the following fasting lipid entry criteria: TG ≥ 150 mg/dL, and HDL-C < 40 mg/dL (males) and < 50 mg/dL (females), and LDL-C ≥ 130 mg/dL. The three multicenter, randomized, double-blind, controlled studies had similar designs, differing primarily in the statin used for combination therapy/monotherapy. Each study compared the effects of 135 mg Trilipix co-administered with either a low dose or a moderate dose of statin with Trilipix monotherapy and statin monotherapy at the corresponding dose on CHD lipid risk factors. A smaller group of patients received a high dose of statin monotherapy. In study 1, patients received Trilipix co-administered with 10 mg or 20 mg rosuvastatin. In study 2, patients received Trilipix co-administered with 20 mg or 40 mg simvastatin. In study 3, patients received Trilipix co-administered with 20 mg or 40 mg atorvastatin.

Patients were enrolled for a total of approximately 22 weeks, consisting of a 6-week diet run-in/washout period, a 12-week treatment period, and a 30-day safety follow up period. Patients who completed the 12-week treatment period were eligible to participate in the 52-week long-term extension study. Of the 2698 randomized and treated subjects in the controlled studies, 51.6% were female and 48.4% were male; 92.6% of all subjects were White, 4.7% were Black, and 2.8% were of other races. Hispanics comprised 9.9% of the study population. Mean age was 54.9 years.

The primary efficacy endpoints for all three studies were mean percent changes from baseline to final value in HDL-C, TG, and LDL-C. For each statin dose co-administered with Trilipix, there were three primary comparisons. For HDL-C and TG, Trilipix co-administered with each statin dose was compared with statin monotherapy at the corresponding dose. For LDL-C, Trilipix co-administered with each statin dose was compared with Trilipix monotherapy. In order to declare combination therapy successful for a particular statin dose, all three primary comparisons were required to demonstrate superiority of the combination therapy over the corresponding monotherapy. The primary efficacy results were consistent in the three studies and were confirmed by the pooled analysis of the three studies. The results from the individual studies and the pooled analysis demonstrated that Trilipix co-administered with low-dose statins and moderate-dose statins was superior to the corresponding monotherapy. Statistically significant differences were observed for all three primary efficacy comparisons for both doses of combination therapy in all three double-blind, controlled studies as well as the pooled analysis.

In the pooled analysis, Trilipix co-administered with both low-dose statins and moderate-dose statins resulted in mean percent increases (18.1% and 17.5%) in HDL-C and mean percent decreases (-43.9% and -42.0%) in TG that were significantly greater than the corresponding dose of statin monotherapy (7.4% and 8.7% for HDL-C; -16.8% and -23.7% for TG). In addition, both doses of combination therapy resulted in mean percent decreases (-33.1% and -34.6%) in LDL-C that were significantly greater than Trilipix monotherapy (-5.1%). The results of the pooled analysis are described in Table 5.

Table 5: Mean Percent Change from Baseline to the Final Value in HDL-C, TG, and LDL-C (Pooled Double-Blind, Controlled

View Enlarged Table

Secondary efficacy endpoints in all three double-blind, controlled studies were percent changes in non-HDL-C (Trilipix co-administered with statin compared to Trilipix monotherapy and corresponding statin monotherapy), and percent changes in VLDL-C, Total-C, and Apo B (Trilipix co-administered with statin compared to corresponding statin monotherapy). Co-administration of Trilipix with statins resulted in the following changes in secondary parameters (Table 6).

Table 6: Percent Change from Baseline to the Final Value in Non-HDL-C, VLDL-C, Total-C, and Apo B (Pooled Double, Blind, Controlled Studies)

View Enlarged Table

A total of 1895 patients who completed 12 weeks of treatment in the double-blind, controlled studies were treated in the 52-week, long-term extension study. Patients received Trilipix co-administered with the moderate-dose of the statin that had been used in the double-blind, controlled study in which they were enrolled. Whether combination therapy was initiated during the double-blind, controlled studies or introduced during the long-term extension study, the treatment effect of combination therapy was observed within four weeks, and was sustained over the duration of treatment in the long-term study. A total of 568 patients completed 52 weeks of treatment with Trilipix co-administered with statins. Mean 52-week values and mean percent change from baseline (at time of enrollment in randomized controlled trials) were 91.7 mg/dL (38.2%) for LDL-C, 47.3 mg/dL (+24.0%) for HDL-C, 135.5 mg/dL (-47.6%) for TG, 117.9 mg/dL (-45.7%) for non-HDL-C, 26.2 mg/dL (-53.1%) for VLDL-C, 165.2 mg/dL (-35.4%) for Total-C, and 81.4 mg/dL (43.6%) for Apo B.

Severe Hypertriglyceridemia

The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemic patients. Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline TG levels of 500 to 1500 mg/dL, and the other TG levels of 350 to 500 mg/dL. In patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia, treatment with fenofibrate at dosages equivalent to 135 mg once daily of Trilipix decreased primarily VLDL-TG and VLDL-C. Treatment of patients with elevated TG often results in an increase of LDL-C (Table 7).

Table 7: Effects of Fenofibrate in Patients With Severe Hypertriglyceridemia

View Enlarged Table

Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

The effects of fenofibrate at a dose equivalent to Trilipix 135 mg once daily were assessed from four randomized, placebo-controlled, double-blind, parallel-group studies including patients with the following mean baseline lipid values: Total-C 306.9 mg/dL; LDL-C 213.8 mg/dL; HDL-C 52.3 mg/dL; and triglycerides 191.0 mg/dL. Fenofibrate therapy lowered LDL-C, Total-C, and the LDL-C/HDL-C ratio. Fenofibrate therapy also lowered triglycerides and raised HDL-C (Table 8).

Table 8. Mean Percent Change in Lipid Parameters at End of Treatment†

Treatment Group Total-C (mg/dL) LDL-C (mg/dL) HDL-C (mg/dL) TG (mg/dL)
Pooled Cohort
Mean baseline lipid values (n = 646) 306.9 213.8 52.3 191.0
All Fenofibrate (n = 361) -18.7%* -20.6%* +11.0%* -28.9%*
Placebo (n = 285) -0.4% -2.2% +0.7% +7.7%
Baseline LDL-C > 160 mg/dL and TG < 150 mg/dL
Mean baseline lipid values (n = 334) 307.7 227.7 58.1 101.7
All Fenofibrate (n = 193) -22.4%* -31.4%* +9.8%* -23.5%*
Placebo (n = 141) +0.2% -2.2% +2.6% +11.7%
Baseline LDL-C > 160 mg/dL and TG > 150 mg/dL
Mean baseline lipid values (n = 242) 312.8 219.8 46.7 231.9
All Fenofibrate (n = 126) -16.8%* -20.1%* +14.6%* -35.9%*
Placebo (n = 116) -3.0% -6.6% +2.3% +0.9%
† Duration of study treatment was 3 to 6 months
* p = < 0.05 vs. Placebo

In a subset of the subjects, measurements of Apo B were conducted. Fenofibrate treatment significantly reduced Apo B from baseline to endpoint as compared with placebo (-25.1% vs. 2.4%, p < 0.0001, n = 213 and 143, respectively).

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

MEDICATION GUIDE

Trilipix
(try-lip-iks)
(fenofibric acid) Delayed Release Capsules

Read this Medication Guide before you start taking Trilipix and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Trilipix?

Trilipix can be used with other cholesterol-lowering medicines called statins. Statins include:

  • atorvastatin (Lipitor, Caduet)
  • fluvastatin (Lescol, Lescol XL)
  • lovastatin (Altoprev, Mevacor, Advicor)
  • pitavastatin (Livalo)
  • pravastatin (Pravachol)
  • rosuvastatin (Crestor)
  • simvastatin (Zocor, Simcor, Vytorin)

Statins can cause muscle pain, tenderness or weakness, which may be symptoms of a rare but serious muscle condition called rhabdomyolysis. In some cases rhabdomyolysis can cause kidney damage and death. The risk of rhabdomyolysis may be higher when Trilipix is given with statins. If you take a statin, tell your healthcare provider.

Other medicines or large amounts of grapefruit juice (more than a quart) may raise the levels of statins in your body, and could then raise the risk of muscle problems. Tell your healthcare provider if you are taking any medicines listed below.

  • Heart medicine
  • Stomach medicine
  • Antibiotic
  • Anti-fungal
  • Cholesterol-lowering medicine
  • Hormones
  • HIV/AIDS medicine
  • Antidepressant
  • Immunosuppressant
  • Anti-seizure medicine

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Tell your healthcare provider if you drink grapefruit juice.

What is Trilipix?

Trilipix is a prescription medicine used to treat cholesterol in the blood by lowering the total amount of triglycerides and LDL (bad) cholesterol, and increasing the HDL (good) cholesterol. Trilipix has not been shown to lower your risk of having heart problems or a stroke. You should be on a low fat and low cholesterol diet while you take Trilipix.

The safety and effectiveness of Trilipix in children is not known.

Who should not take Trilipix?

Do not take Trilipix if you:

  • are allergic to fenofibric acid, or any of the ingredients in Trilipix. See the end of this Medication Guide for a list of all the ingredients in Trilipix.
  • have severe kidney disease.
  • have liver disease.
  • have gallbladder disease.
  • are a nursing mother.

Talk to your healthcare provider before you take Trilipix if you have any of these conditions.

What should I tell my healthcare provider before taking Trilipix?

Before taking Trilipix, tell your healthcare provider about all your medical conditions, including if you:

  • are allergic to any medicines.
  • have ever had kidney problems.
  • have ever had liver problems.
  • have ever had gallbladder problems.
  • are pregnant or if you plan to become pregnant. It is not known if Trilipix will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Trilipix passes into your breast milk. You and your healthcare provider should decide if you will take Trilipix or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Using Trilipix with certain other medicines can affect the way these medicines work and other medicines may affect how Trilipix works. In some cases, using Trilipix with other medicines can cause serious side effects.

Know all the medicines you take. Keep a list of them and show it to your healthcare provider when you get a new medicine.

It is especially important to tell your healthcare provider if you take any of the medicines mentioned in, "What is the most important information I should know about Trilipix?" or any of the medicines listed below:

  • anticoagulants, also known as blood thinners (warfarin, Coumadin)
  • bile acid resins
  • cyclosporine

Ask your healthcare provider if you are not sure if your medicine is one of these.

How should I take Trilipix?

  • You should be on a low fat and low cholesterol diet while you take Trilipix.
  • Take Trilipix one time each day as prescribed by your healthcare provider.
  • Take Trilipix with or without food.
  • Swallow Trilipix capsules whole. Do not break, crush, dissolve, or chew Trilipix capsules before swallowing. If you cannot swallow Trilipix capsules whole, tell your healthcare provider, you may need a different medicine.
  • If you take a medicine called a statin, you can take Trilipix and your statin at the same time of day.
  • If you miss a dose of Trilipix, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. If you are not sure about your dosing, call your healthcare provider. Do not take more than one dose of Trilipix a day unless your healthcare provider tells you to.
  • If you take too much Trilipix, contact your healthcare provider or your local emergency department.
  • Do not change your dose or stop Trilipix unless your healthcare provider tells you to.
  • Your healthcare provider may do blood tests before you start taking Trilipix and during treatment. See your healthcare provider regularly to check your cholesterol and triglyceride levels and to check for side effects.

What are the possible side effects with Trilipix?

Trilipix may cause serious side effects, including:

  • muscle pain, tenderness, or weakness. See "What is the most important information that I should know about Trilipix?"
  • tiredness and fever.
  • abdominal pain, nausea, or vomiting. These may be signs of inflammation (swelling) of the gallbladder or pancreas.

Call your healthcare provider right away if you have any of these serious side effects.

The most common side effects with Trilipix include:

  • headache
  • heartburn (indigestion)
  • nausea
  • muscle aches
  • increases in muscle or liver enzymes that are measured by blood tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trilipix. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

How do I store Trilipix?

  • Store Trilipix between 59° to 86° F (15° to 30° C).
  • Protect Trilipix from moisture.

Keep Trilipix and all medicines out of the reach of children.

General information about the safe and effective use of Trilipix

Medicines are sometimes prescribed for conditions that are not mentioned in the Medication Guide. Do not use Trilipix for a condition for which it was not prescribed. Do not give Trilipix to other people, even if they have the same condition you have. It may harm them.

This Medication Guide summarizes the most important information about Trilipix. If you would like more information, talk to your healthcare provider. You can also ask your pharmacist or healthcare provider for information that is written for health professionals.

For more information go to www.Trilipix.com or call 1-800-633-9110.

What are the ingredients in Trilipix?

Active Ingredient: Fenofibric acid
Inactive Ingredients: Hypromellose, povidone, water, hydroxylpropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate, gelatin, titanium dioxide, and yellow iron oxide. Additionally, the 45 mg capsule shell contains black iron oxide and red iron oxide, and the 135 mg capsule shell contains FD&C Blue #2.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

FENOFIBRIC ACID DELAYED-RELEASE - ORAL

 

(FEN-oh-FYE-brick)

 

COMMON BRAND NAME(S): Trilipix

 

USES: Fenofibric acid is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "fibrates." It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibric acid might not lower your risk of a heart attack or stroke. Talk to your doctor about the risk and benefits of fenofibric acid.

In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, drinking less alcohol, losing weight if overweight, and stopping smoking.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking fenofibric acid and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor.

Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects.

Dosage is based on your medical condition and response to treatment. Do not take more than 135 milligrams per day.

If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fenofibric acid at least 1 hour before or at least 4-6 hours after taking these medications. These products can react with fenofibric acid, preventing its full absorption.

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick.

It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 2 months before you get the full benefit of this drug.

Consumer Overview Side Effect

SIDE EFFECTS: Nausea and headache may occur. If either of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may infrequently cause gallstones and liver problems. If you notice any of the following unlikely but very serious side effects, tell your doctor immediately: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

Rarely, this medication has caused severe lowering of HDL ("good" cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your laboratory appointments.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), chest pain, pain/redness/swelling of arms or legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Trilipix (fenofibric acid capsules) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking fenofibric acid, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: gallbladder disease, liver disease (such as biliary cirrhosis, hepatitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, kidney disease.

Older adults may be more sensitive to the effects of this drug, especially muscle problems.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), drugs that may be harmful to the kidneys (such as cyclosporine, NSAIDs such as ibuprofen).

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as blood cholesterol/triglyceride levels, kidney/liver function tests, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. (See also Side Effects section.)

Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Fibricor, Trilipix

Generic Name: fenofibric acid (Pronunciation: FEN oh FYE brik AS id)

  • What is fenofibric acid (Trilipix)?
  • What are the possible side effects of fenofibric acid (Trilipix)?
  • What is the most important information I should know about fenofibric acid (Trilipix)?
  • What should I discuss with my healthcare provider before taking fenofibric acid (Trilipix)?
  • How should I take fenofibric acid (Trilipix)?
  • What happens if I miss a dose (Trilipix)?
  • What happens if I overdose (Trilipix)?
  • What should I avoid while taking fenofibric acid (Trilipix)?
  • What other drugs will affect fenofibric acid (Trilipix)?
  • Where can I get more information?

What is fenofibric acid (Trilipix)?

Fenofibric acid helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Fenofibric acid is used to treat high cholesterol and high triglyceride levels. It is sometimes given together with other cholesterol-lowering medications.

Fenofibric acid may also be used for purposes not listed in this medication guide.

What are the possible side effects of fenofibric acid (Trilipix)?

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking fenofibric acid and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using fenofibric acid and call your doctor at once if you have a serious side effect such as:

  • sharp stomach pain spreading to your back or shoulder blade;
  • stomach pain just after eating a meal;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pain, swelling, warmth, or redness in one or both legs; or
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.

Less serious side effects may include:

  • headache, dizziness;
  • back pain;
  • joint pain;
  • diarrhea, upset stomach; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Trilipix (fenofibric acid capsules) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about fenofibric acid (Trilipix)?

You should not take fenofibric acid if you are allergic to it, or if you have liver disease, gallbladder disease, severe kidney disease (or if you are on dialysis), or if you are breast-feeding a baby.

Before you take fenofibric acid, tell your doctor if you have kidney disease, diabetes, or underactive thyroid.

Fenofibric acid is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Avoid eating foods that are high in fat or cholesterol. Fenofibric acid will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Side Effects Centers
  • Trilipix
  • Fibricor

Patient Detailed How Take

What should I discuss with my healthcare provider before taking fenofibric acid (Trilipix)?

You should not take fenofibric acid if you are allergic to it, or if you have:

  • severe kidney disease (or if you are on dialysis);
  • liver disease;
  • gallbladder disease; or
  • if you are breast-feeding a baby.

To make sure you can safely take fenofibric acid, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • diabetes; or
  • underactive thyroid.

FDA pregnancy category C. It is not known whether fenofibric acid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Do not breast-feed while you are taking fenofibric acid.

How should I take fenofibric acid (Trilipix)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take fenofibric acid with or without food.

If you also take cholestyramine (Questran), colesevelam (Welchol), or colestipol (Colestid), take these medicines at least 1 hour after taking fenofibric acid, or 4 to 6 hours before taking fenofibric acid. Do not take any of these medicines at the same time you take fenofibric acid.

"Statin" cholesterol-lowering medications may be taken at the same time as fenofibric acid.

Fenofibric acid is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver, kidney, and gallbladder function may also need to be tested. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Trilipix
  • Fibricor

Patient Detailed Avoid Taking

What happens if I miss a dose (Trilipix)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Trilipix)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking fenofibric acid (Trilipix)?

Avoid eating foods that are high in fat or cholesterol. Fenofibric acid will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

What other drugs will affect fenofibric acid (Trilipix)?

Tell your doctor about all other medications you use, especially:

  • cyclosporine (Neoral, Sandimmune, Gengraf);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • a diuretic (water pill);
  • birth control pills or hormone replacement therapy; or
  • a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others.

This list is not complete and other drugs may interact with fenofibric acid. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about fenofibric acid.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.01. Revision date: 3/30/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers
  • Trilipix
  • Fibricor

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