Physician FAQs
Here are some of the most commonly asked questions we've received from healthcare professionals about LOFIBRA®.
Does LOFIBRA® have to be taken at mealtimes?
What are the approved indications?
What are the safety considerations?
What are the possible drug interactions?
Who is Teva Biologics & Specialty Products ?
How does LOFIBRA® work?
The 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, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity).
The resulting fall in triglycerides 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 apoproteins A-I, A-II, and HDL-cholesterol.
Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.
return to topDoes LOFIBRA® have to be taken at mealtimes?
Yes. LOFIBRA® is more efficacious when taken with a meal. We believe this consistent dosing schedule enhances compliance by giving patients a regular daily routine.
return to topWhat are the approved indications?
LOFIBRA® [fenofibrate tablets and capsules (micronized)] is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia usually obviates the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., >2000 mg/dL) may increase the risk of developing pancreatitis. The effect of LOFIBRA® in relation to this risk has not been adequately studied.
LOFIBRA® [fenofibrate tablets and capsules (micronized)] is also indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, triglycerides, and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacologic interventions alone has been inadequate.
LOFIBRA® Tablets are also indicated to increase HDL-C in adult patients with hypercholesterolemia or mixed dyslipidemia.
return to topWhat are the safety considerations?
Dietary therapy, reduction in excess weight and alcohol intake, and treatment of medical problems contributing to lipid abnormalities should be attempted prior to treatment with LOFIBRA®. Discontinuation of estrogen therapy, thiazide diuretics, and beta-blockers in familial hypertriglyceridemia may avoid the need for specific drug therapy.
Fenofibrate is contraindicated in hepatic or severe renal dysfunction, including primary biliary cirrhosis, unexplained liver function abnormality, preexisting gallbladder disease, and hypersensitivity to fenofibrate.
Fenofibrate has been associated with increases in serum transaminases (ALT or AST) and creatine phosphokinase. Regular periodic monitoring of liver function should be performed for the duration of therapy and fenofibrate discontinued if enzyme levels persist three times above normal.
Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. LOFIBRA® should be discontinued if gallstones are found.
The effect of fenofibrate on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. Pancreatitis has been reported in patients taking fenofibrate. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate in 1.6% of patients.
return to topWhat are the possible drug interactions?
LOFIBRA® may increase the effects of coumarin-type anticoagulants. Dosage adjustment based on frequent prothrombin time/INR determinations is advisable.
Use with HMG-CoA reductase inhibitors should be avoided unless the benefits outweigh the risks. The use of fenofibrate alone may be associated with myositis, myopathy, or rhabdomyolysis and should be stopped if myopathy/myositis is suspected or diagnosed.
return to top
Who is Teva Biologics & Specialty Products ?
Click here to see information about TBSP.
return to topIndication
Treatment of Hypercholesterolemia
LOFIBRA® (fenofibrate capsules [micronized] and fenofibrate tablets) is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and APoB, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate. The effect of fenofibrate on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.
Treatment of Hypertriglyceridemia
LOFIBRA® is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.
Important Safety Information
Diet therapy, exercise, weight loss, reduced alcohol intake, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to lipid abnormalities should be attempted prior to treatment with LOFIBRA®. Medications known to exacerbate hypertriglyceridemia (betablockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
LOFIBRA® is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, unexplained persistent liver function abnormality, preexisting gallbladder disease, or hypersensitivity to fenofibrate.
Fenofibrate has been associated with increases in serum transaminases (ALT [SGPT] or AST [SGOT]) and creatine phosphokinase. Regular periodic monitoring of liver function should be performed for the duration of therapy with LOFIBRA®. Therapy should be discontinued if enzyme levels persist above three times the normal limit or if gallstones are found.
Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. Caution should be exercised when anticoagulants are given in conjunction with LOFIBRA® because LOFIBRA® may increase the effects of coumarin-type anticoagulants. Anticoagulant dosage adjustment based on frequent prothrombin time/INR determinations is advisable.
Use with HMG-CoA reductase inhibitors should be avoided unless the benefits outweigh the risks. The use of fenofibrate alone may be associated with myositis, myopathy, or rhabdomyolysis. Patients complaining of muscle pain, tenderness, or weakness should have prompt medical evaluation for myopathy, including serum creatine kinase level determination.
The dosage of fenofibrate should be minimized in patients with severe renal impairment. Because of differences in the pharmacokinetic profile between capsule and tablet formulations they should be interchanged with monitoring.
Adverse events reported by ≥4% of patients receiving LOFIBRA® in controlled clinical trials were abdominal pain, abnormal liver function tests, and respiratory disorders. Pancreatitis, thromboembolism, and hematologic changes have been reported.
