Trirole®

100-200 mg once daily

Contraindications:

Hypersensitivity to fenofibrate or fenofibric acid or any component of the formulation; active liver disease, including primary biliary cirrhosis and unexplained, persistent liver function abnormality; severe renal impairment or end-stage renal disease, including those receiving dialysis; preexisting gallbladder disease; breastfeeding

Interactions:

Bile Acid Sequestrants: May decrease the absorption of Fibric Acid Derivatives. Management: Separate doses by at least 2 hours to minimize this interaction; fenofibric acid labeling recommends administration one hour prior to or 4-6 hours after a bile acid sequestrant. Risk D: Consider therapy modification

HMG-CoA Reductase Inhibitors (Statins): Fenofibrate and Derivatives may enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Sulfonylureas: Fibric Acid Derivatives may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

 

Pregnancy and Lactation:

Triglyceride and lipid concentrations increase during pregnancy as required for normal fetal development. When increases are greater than expected, supervised dietary intervention should be initiated. In women who develop very severe hypertriglyceridemia and are at risk for pancreatitis, use of fenofibrate beginning in the second trimester is one intervention that may be considered.

It is not known if fenofibrate is present in breast milk. When treatment for very severe hypertriglyceridemia in breastfeeding women at risk for pancreatitis is needed, therapy with fenofibrate may be considered

Warning and Precaution:

• Cholelithiasis: May cause cholelithiasis; discontinue if gallstones are found upon gallbladder studies.
• HDL cholesterol: A paradoxical, severe, and reversible decrease in HDL-C (as low as 2 mg/dL) with a

simultaneous decrease in apolipoprotein A1 has been reported within 2 weeks to years after initiation

of fibrate therapy; clinical significance unknown. Monitor HDL-C within a few months of initiation of

therapy and discontinue if HDL-C becomes severely depressed; do not restart therapy.

• Hematologic effects: May cause mild-to-moderate decreases in hemoglobin, hematocrit and WBC

upon initiation of therapy which usually stabilizes with long-term therapy. Agranulocytosis and

thrombocytopenia has been reported. Periodic monitoring of blood counts is recommended during

the first year of therapy.

• Hepatic effects: Hepatic transaminases can become significantly elevated (dose related); serious

drug-induced liver injury has been reported after weeks to several months of therapy (some cases

have resulted in death or required liver transplant); may be characterized as hepatocellular, chronic

active, and cholestatic hepatitis, and cirrhosis has occurred in association with chronic active hepatitis.

• Hypersensitivity reactions: Acute hypersensitivity reactions, including anaphylaxis and angioedema,

have been reported. Additionally, delayed hypersensitivity reactions, including severe cutaneous

adverse reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and

drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported, occurring days

two weeks following fenofibrate initiation. Discontinue immediately for severe acute or delayed

hypersensitivity reactions.

• Myopathy/Rhabdomyolysis: Has been associated with rare myositis, myopathy, or rhabdomyolysis;

monitor patients closely. Risk increased in the elderly, those receiving concomitant HMG-CoA

reductase inhibitors or colchicine, and patients with diabetes mellitus, renal insufficiency, or

hypothyroidism. Instruct patients to report unexplained muscle pain, tenderness, weakness, especially

if accompanied with malaise or fever; or brown urine. Discontinue therapy in patients who develop

markedly elevated CPK concentrations or if myopathy/myositis is suspected or diagnosed.

• Pancreatitis: Pancreatitis has been reported with fenofibrate use; may be secondary to a failure of

efficacy in patients with severe hypertriglyceridemia, medication side effect, or due to biliary tract

stone or sludge formation from bile duct obstruction.

• Photosensitivity: Photosensitivity reactions have been reported, sometimes days to months after

therapy was initiated; some patients reported previous photosensitivity to ketoprofen.

• Renal effects: Increases in serum creatinine (>2 mg/dL) have been observed with use; clinical

significance unknown. These elevations tend to return to baseline following discontinuation of

fenofibrate. Fenofibrate has been shown to increase creatinine production (unknown mechanism)

resulting in an equal increase of creatinuria thereby demonstrating that the increase does not reflect a

reduction in creatinine clearance. Monitor renal function in patients with renal

impairment; consider monitoring renal function in patients with increased risk for developing renal

impairment (eg, elderly and patients with diabetes).

Adverse Reactions:

Hepatic: Increased serum alanine aminotransferase (≥3 x ULN: ≤13%), increased serum aspartate aminotransferase (≥3 x ULN: ≤13%), Skin rash, urticaria, Abnormal hepatic function tests,

Storage:

Store below 30 and protect from light and moisture.