Adult Dosing
Severe hypertriglyceridemia
Fibricor
- Initial dose: 35-105 mg PO qd
- Max: 105 mg/day
Note:
- Adjust the dose, if necessary, after repeat lipid determinations at 4-8 wk intervals
Trilipix
- Initial dose: 45-135 mg PO qd
- Max: 135 mg/day
Note:
- Adjust the dose, if necessary, after repeat lipid determinations at 4-8 wk intervals
Primary hyperlipidemia
Fibricor
- Start with 105 mg PO qd
- Max: 105 mg/day
Trilipix
- Start with 135 mg PO qd
- Max: 135 mg/day
Mixed dyslipidemia
Fibricor
- Start with 105 mg PO qd
- Max: 105 mg/day
Trilipix
- Start with 135 mg PO qd
- Max: 135 mg/day
Co-administration with statins (HMG-CoA reductase inhibitor) for treatment of mixed dyslipidemia
Trilipix
- 135 mg/day PO with HMG-CoA reductase inhibitor; daily dose of Trilipix may be taken at the same time as a statin
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Patients treated with either statin or fibrate monotherapy are at an increased risk of myositis or myopathy, and have been associated with rhabdomyolysis. The risk for rhabdomyolysis appears to be increased when fibrates are co-administered with a statin
- The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, hypothyroidism, or renal failure
- Myopathy should be considered in patients with diffuse myalgias, muscle tenderness/weakness, and/or marked elevations of CPK levels. Assess CPK levels in patients presenting with unexplained muscle pain, tenderness or weakness, especially if associated with malaise or fever. Discontinue therapy if CPK levels are markedly elevated or a diagnosis of myositis or myopathy is made
- Fenofibric acid used as monotherapy or co-administered with low to moderate doses of statins has been associated with increase in serum transaminase levels. Increase in transaminase levels may be dose dependent. Hepatocellular, chronic active, and cholestatic hepatitis observed with fenofibrate therapy have occurred after exposures of weeks to several years. Rarely, cirrhosis of liver has been reported in association with chronic active hepatitis. Monitor liver functions regularly, including serum ALT (SGPT) for the duration of therapy. Discontinue therapy if enzyme levels persist above 3x the upper limit of normal
- Reversible elevations in serum creatinine have been reported in patients receiving fenofibric acid as monotherapy or co-administered with statins
- Therapy may increase cholesterol excretion into the bile resulting in cholelithiasis. Conduct gallbladder studies if cholelithiasis is suspected. Discontinue therapy if gallstones are observed
- Caution should be exercised when administering fenofibric acid in conjunction with oral coumarin anticoagulants. Fenofibric acid may potentiate the anticoagulant effects of these agents causing prolongation of prothrombin time/INR. Frequently monitor prothrombin time/INR and adjust the oral anticoagulant doses until the prothrombin time/INR has stabilized in order to prevent bleeding complications
- Effect of fenofibric acid on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established
- Medications known to exacerbate hypertriglyceridemia should be discontinued or changed if possible, and the issue of excessive alcohol consumption should be addressed prior to considering triglyceride-lowering drug therapy. The importance of adhering to an appropriate lipid-lowering diet, even after initiating therapy, should be emphasized
- Pancreatitis has been reported in patients receiving fenofibric acid. This may be due to ineffectiveness of the drug 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
- Cases of pulmonary embolus (PE) and deep vein thrombosis (DVT) were observed at a higher rate in the fenofibrate-treated group compared to the placebo in clinical studies
- Rare occasions of acute hypersensitivity reactions including severe skin rashes requiring patient hospitalization and treatment with steroids have been reported during therapy, including rare spontaneous reports of Stevens-Johnson syndrome and toxic epidermal necrolysis
- Hematologic changes such as mild to moderate decreases in hemoglobin, hematocrit, and white blood cells have occurred following initiation of fenofibric acid therapy. Periodically determine blood counts during the first 12 months of therapy
- Severe decrease in HDL cholestrol levels in diabetic and non-diabetic patients have been reported in postmarketing setting of fenofibric acid. Discontinue the therapy if severely depressed HDL-C level is detected and monitor patient until it returns to baseline
Cautions: Use cautiously in
- Renal impairment
- Concurrent nephrotoxic agents
Supplemental Patient Information
- Advise patients to promptly inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms during therapy
Pregnancy Category:C
Breastfeeding: Manufacturer recommends not to be used in nursing mothers.
US Trade Name(s)
US Availability
fenofibric acid (generic)
- Delayed Release CAPS: 45, 135 mg
Fibricor
Trilipix
- Delayed Release CAPS: 45, 135 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Trilipix 45 MG CPDR [Bottle] (ABBOTT)
90 mg = $156.99
270 mg = $451.97 - Trilipix 135 MG CPDR [Bottle] (ABBOTT)
90 mg = $476.98
270 mg = $1343.02
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
500 mg/dl)