Trilipix Information
Trilipix (Fenofibric) Indications And Usage
Trilipix (Fenofibric) 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:
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No incremental benefit of Trilipix (Fenofibric) on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established.
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Trilipix (Fenofibric) 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.
Trilipix (Fenofibric) Dosage And Administration
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Patients should be placed on an appropriate lipid-lowering diet before receiving Trilipix (Fenofibric) as monotherapy or co-administered with a statin , and should continue this diet during treatment. Trilipix (Fenofibric) delayed release capsules can be taken without regard to meals. Serum lipids should be monitored periodically. The maximum dose is 135 mg once daily.
Trilipix (Fenofibric) Contraindications
Trilipix (Fenofibric) is contraindicated in:
When Trilipix (Fenofibric) is co-administered with a statin, refer to the section of the respective statin labeling.
Trilipix (Fenofibric) Warnings And Precautions
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 significantly higher rate observed for gemfibrozil). 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.
Myalgia was reported in 3.3% of patients treated with Trilipix (Fenofibric) monotherapy and 3.1% to 3.5% of patients treated with Trilipix (Fenofibric) 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 (Fenofibric) monotherapy and 0.2% to 1.2% of patients treated with Trilipix (Fenofibric) 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 (Fenofibric) and statin therapy should be discontinued if markedly elevated CPK levels occur or myopathy or myositis is diagnosed.
Trilipix (Fenofibric) 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 (Fenofibric) 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 (Fenofibric) monotherapy and in 1.3% and 0.4%, respectively, of patients receiving Trilipix (Fenofibric) 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 (Fenofibric) co-administered 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 (Fenofibric) once daily and was 0% in those receiving dosages equivalent to 45 mg Trilipix (Fenofibric) 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.
Regular monitoring of liver function, including serum ALT (SGPT) should be performed for the duration of therapy with Trilipix (Fenofibric) , and therapy discontinued if enzyme levels persist above 3 times the upper limit of normal.
The effect of Trilipix (Fenofibric) on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. Because of similarities between Trilipix (Fenofibric) 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 (Fenofibric) .
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% CI 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% CI 0.69-0.99), and the hazard ratio for MACE in women receiving combination therapy versus statin monotherapy was 1.38 (95% CI 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% CI 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 =
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).
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
Trilipix (Fenofibric) Use In Specific Populations
Pregnancy Category: C
The safety of Trilipix (Fenofibric) in pregnant women has not been established. There are no adequate and well controlled studies of Trilipix (Fenofibric) in pregnant women. Trilipix (Fenofibric) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
When Trilipix (Fenofibric) 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/m). 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/m). No developmental findings were observed at 15 mg/kg/day (at less than 1 times the MRHD, based on body surface area comparisons; mg/m).
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/m.
Trilipix (Fenofibric) Overdosage
There is no specific treatment for overdose with Trilipix (Fenofibric) . 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 (Fenofibric) is highly bound to plasma proteins, hemodialysis should not be considered.
Trilipix (Fenofibric) Description
Trilipix (Fenofibric) (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:
The empirical formula is CHClNO 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.
Trilipix (Fenofibric) Clinical Pharmacology
The active moiety of Trilipix (Fenofibric) 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 transgenic mice and 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 AII.
Trilipix (Fenofibric) contains fenofibric acid, which is the only circulating pharmacologically active moiety in plasma after oral administration of Trilipix (Fenofibric) . 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 (Fenofibric) delayed release capsule are equivalent to those after one 200 mg capsule of micronized fenofibrate administered under fed conditions.
Absorption
Peak plasma levels of fenofibric acid occur within 4 to 5 hours after a single dose administration of Trilipix (Fenofibric) capsule under fasting conditions.
Fenofibric acid exposure in plasma, as measured by C and AUC, is not significantly different when a single 135 mg dose of Trilipix (Fenofibric) is administered under fasting or nonfasting conditions.
Distribution
Metabolism
In vivo
Excretion
Fenofibric acid is eliminated with a half-life of approximately 20 hours, allowing once daily administration of Trilipix (Fenofibric) .
Pediatrics
Gender
Race
Renal Impairment
Hepatic Impairment
Comparison of atorvastatin exposures when atorvastatin (80 mg QD for 10 days) is given in combination with fenofibric acid (Trilipix (Fenofibric) 135 mg QD for 10 days) and ezetimibe (10 mg QD for 10 days) versus when atorvastatin is given in combination with ezetimibe only (ezetimibe 10 mg QD and atorvastatin, 80 mg QD for 10 days): The C 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 QD for 10 days) is given in combination with fenofibric acid (Trilipix (Fenofibric) 135 mg QD for 10 days) and atorvastatin (80 mg QD for 10 days) versus when ezetimibe is given in combination with atorvastatin only (ezetimibe 10 mg QD and atorvastatin, 80 mg QD for 10 days): The C 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.
Trilipix (Fenofibric) Clinical Studies
Efficacy and safety of Trilipix (Fenofibric) 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
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 (Fenofibric) , there were three primary comparisons. For HDL-C and TG, Trilipix (Fenofibric) co-administered with each statin dose was compared with statin monotherapy at the corresponding dose. For LDL-C, Trilipix (Fenofibric) co-administered with each statin dose was compared with Trilipix (Fenofibric) 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 (Fenofibric) 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 (Fenofibric) 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 (Fenofibric) monotherapy (-5.1%). The results of the pooled analysis are described in Table 5.
Secondary efficacy endpoints in all three double-blind, controlled studies were percent changes in non-HDL-C (Trilipix (Fenofibric) co-administered with statin compared to Trilipix (Fenofibric) monotherapy and corresponding statin monotherapy), and percent changes in VLDL-C, Total-C, and Apo B (Trilipix (Fenofibric) co-administered with statin compared to corresponding statin monotherapy). Co-administration of Trilipix (Fenofibric) with statins resulted in the following changes in secondary parameters (Table 6).
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 (Fenofibric) 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 (Fenofibric) 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.
The effects of fenofibrate at a dose equivalent to Trilipix (Fenofibric) 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).
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
Trilipix (Fenofibric) How Supplied/storage And Handling
Trilipix (Fenofibric) (fenofibric acid) delayed release capsules are supplied in two dose strengths as follows:
Storage and Handling
Store Trilipix (Fenofibric) 45 and 135 mg delayed release capsules 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.
Trilipix (Fenofibric) Patient Counseling Information
Trilipix (Fenofibric) Medication Guide
(try-lip-iks)
(fenofibric acid, delayed release capsules)
Read this Medication Guide before you start taking Trilipix (Fenofibric) 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.
Trilipix (Fenofibric) can be used with other cholesterol-lowering medicines called statins. Statins include:
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 (Fenofibric) 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.
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.
Trilipix (Fenofibric) 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.You should be on a low fat and low cholesterol diet while you take Trilipix (Fenofibric) .
The safety and effectiveness of Trilipix (Fenofibric) in children is not known.
Using Trilipix (Fenofibric) with certain other medicines can affect the way these medicines work and other medicines may affect how Trilipix (Fenofibric) works. In some cases, using Trilipix (Fenofibric) 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.
Ask your healthcare provider if you are not sure if your medicine is one of these.
The most common side effects with Trilipix (Fenofibric) include:
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 (Fenofibric) . 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-FDA-1088.
Medicines are sometimes prescribed for conditions that are not mentioned in the Medication Guide. Do not use Trilipix (Fenofibric) for a condition for which it was not prescribed. Do not give Trilipix (Fenofibric) 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 (Fenofibric) . 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 (Fenofibric) .com or call 1-800-633-9110.
©Abbott
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.
Rev. 09/2011 Abbott Laboratories
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Trilipix (Fenofibric)
