EP-Feno

Fenofibrate

Adjunct to diet & other non-pharmacological treatment (eg, exercise, wt reduction) for the treatment of severe hypertriglyceridaemia w/ or w/o low HDL-C; mixed hyperlipidaemia when statin is contraindicated or not tolerated; & mixed hyperlipidaemia in patients at high CV risk in addition to statin when triglycerides & HDL-C are not adequately controlled.

Adult 145 mg once daily. Patient w/ renal impairment (eGFR 30-59 mL/min/1.73 m²) Max: 100 mg standard or 67 mg micronized once daily.

May be taken with or without food: Swallow whole w/ water.

Hypersensitivity. Known photoallergy or phototoxic reaction during treatment w/ fibrates or ketoprofen. Known gallbladder disease. Chronic or acute pancreatitis (except acute pancreatitis due to severe hypertriglyceridemia). Hepatic insufficiency (including biliary cirrhosis & unexplained persistent liver function abnormality). Severe renal insufficiency (eGFR <30 mL/min/1.73 m²).

Adequately treat secondary causes of hypercholesterolemia (eg, uncontrolled type 2 DM, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease or alcoholism) before fenofibrate therapy is considered. Reports of increased transaminase levels; pancreatitis; muscle toxicity, including rare cases of rhabdomyolysis, w/ or w/o renal failure; reversible elevations in serum creatinine. Monitor transaminase levels every 3 mth during the 1st 12 mth of treatment & thereafter periodically. Discontinue therapy if AST & ALT levels increase to >3x ULN, & in case of confirmed hepatitis. Increased risk of developing rhabdomyolysis in patients w/ pre-disposing factors for myopathy &/or rhabdomyolysis, including age >70 yr, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism & high alcohol intake. Stop treatment in patients presenting diffuse myalgia, myositis, muscular cramps & weakness &/or marked increases in creatine phosphokinase levels (>5x ULN). Reserve co-administration w/ HMG-CoA reductase inhibitor or another fibrate to patients w/ severe combined dyslipidaemia & high CV risk w/o any history of muscular disease & those w/ close monitoring of potential muscle toxicity. Measure creatinine during the 1st 3 mth after treatment initiation & periodically thereafter. Interrupt treatment when creatinine level is 50% above ULN. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Caution in patients w/ mild to moderate renal insufficiency. Discontinue use if eGFR decreases persistently to <30 mL/min/1.73 m² during follow-up. Not recommended in patients w/ hepatic impairment. Should only be used during pregnancy after careful benefit/risk assessment. Do not use during breast-feeding. Not recommended in childn & adolescents <18 yr.

GI signs & symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence); increased transaminases; increased blood homocysteine level.

Enhances oral anticoagulant effect & may increase risk of bleeding. Reports of reversible severe renal impairment during concomitant administration w/ ciclosporin. Increased risk of serious muscle toxicity if concomitantly used w/ HMG-CoA reductase inhibitors or other fibrates. Reports of reversible paradoxical HDL-C reduction during concomitant administration w/ glitazones. Carefully monitor if co-administered w/ CYP2C19-, CYP2A6-, & especially CYP2C9-metabolised drugs w/ narrow therapeutic index.

Dyslipidaemic Agents

C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.

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