Fenoglide Generic Name & Formulations
Fenofibrate 40mg, 120mg; tabs.
Adjunct to diet in severe hypertriglyceridemia and to reduce elevated LDL-C, total-C, TG, and apo B, and to increase HDL-C, in primary hyperlipidemia or mixed dyslipidemia.
Limitations of Use
Not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Fenoglide Dosage and Administration
Take with food. Hypertriglyceridemia: 40–120mg/day; adjust at 4–8 week intervals; max 120mg/day. Hyperlipidemia, dyslipidemia: initially 120mg/day. Mild to moderately renal impairment: initially 40mg/day. Elderly: select dose based on renal function.
Severe renal impairment (including dialysis). Active liver disease. Unexplained persistent liver function abnormalities. Primary biliary cirrhosis. Gallbladder disease. Nursing mothers (during and for 5 days after last dose).
Fenoglide Boxed Warnings
Risk of serious liver injury. Monitor liver function at baseline and periodically during therapy; discontinue if liver injury develops or if elevated enzymes persist (ALT or AST >3×ULN, or if accompanied by elevated bilirubin); do not restart if no alternative explanation. Monitor CBCs during the first year. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions, or paradoxical decreases in HDL occur (do not reinitiate). Diabetes. Hypothyroidism. Mild to moderate renal impairment: reduce dose; monitor. Elderly. Pregnancy.
Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR); caution. Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Fenoglide Adverse Reactions
Abnormal liver function tests, increased AST, ALT, CPK, rhinitis; respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, rash, hypersensitivity reactions (may be severe); rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.
Fenoglide Clinical Trials
Fenoglide Patient Counseling