APO-FENOFIBRATE

What it is

APO-FENOFIBRATE is fenofibrate, available as 48 mg and 145 mg film-coated tablets for oral administration. The 48 mg tablet is yellow coloured, oval shaped, and biconvex, debossed with 'cipla' on one side and code '459' on the other. The 145 mg tablet is white to off white coloured, oval shaped, and biconvex, debossed with 'cipla' on one side and code '458' on the other.

Approved indications

APO-FENOFIBRATE is indicated as an adjunct to diet in the treatment of: — Hypercholesterolaemia — Types II, III, IV and V dyslipidaemia — Dyslipidaemia associated with type 2 diabetes

Dosing overview

The usual dose of fenofibrate for adults with dyslipidaemia is 1 × 145 mg tablet. The 48 mg tablets are only recommended when a decreased dosage is required. In moderate renal dysfunction (eGFR between 30 and 60 mL/min/1.73m²), start with one 48 mg tablet once daily; the dose may be increased to two 48 mg tablets daily only after evaluation of renal function and lipid levels at the lower dose. Tablets may be given at any time of the day, with or without food, but should be taken at the same time each day.

Key safety warnings

Elevations in serum creatinine have been reported in patients on fenofibrate, which tend to return to baseline following discontinuation, though the clinical significance is unknown. Creatinine should be measured during the first 3 months after initiation of treatment and thereafter periodically. Fenofibrate has been associated with increases in serum transaminases, which usually return to normal limits on discontinuation or continued treatment; the incidence appears dose-related; baseline and ongoing monitoring every 3 months during the first 12 months and thereafter periodically should be performed. Therapy should be discontinued if AST and ALT levels increase to more than 3 times the upper limit of normal. Reports exist of elevations of creatine phosphokinase, myositis and myopathy associated with fenofibrate, with rhabdomyolysis reported rarely; patients with muscle pain, tenderness or weakness require prompt medical evaluation, and fenofibrate should be withdrawn if myositis is suspected or if CPK rises to ≥5 times the upper limit of normal. Patients with predisposing factors including age above 70 years, personal or familial history of hereditary muscular disorders, renal impairment, hypoalbuminaemia, hypothyroidism and high alcohol intake may be at increased risk; the putative benefits and risks should be carefully weighed. In the FIELD trial, pulmonary embolus and deep vein thrombosis were observed at higher rates in the fenofibrate-treated group than placebo, with 67 DVT events (1.4%) versus 48 events (1%) in placebo, and 53 PE events (1.1%) versus 32 events (0.7%) in placebo.

Contraindications

APO-FENOFIBRATE is contraindicated in children; patients with liver dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormality; patients with severe renal dysfunction (eGFR <30 mL/min/1.73m²); patients with existing gallbladder disease; concomitant use with another fibrate; patients hypersensitive to fenofibrate or excipients, or with known photoallergy or phototoxic reactions during treatment with fibrates or ketoprofen; chronic or acute pancreatitis except acute pancreatitis due to severe hypertriglyceridaemia; and patients allergic to peanuts, arachis oil, soya lecithin or related products due to risk of hypersensitivity reactions.

Regulatory history

APO-FENOFIBRATE fenofibrate 145 mg tablets (ARTG 291652) and 48 mg tablets (ARTG 291653) were first listed on 17 May 2019 under licence category RE.