FENOFIBRATE-WGR

What it is

Fenofibrate-WGR is a fenofibrate tablet medicine available in two strengths: 48 mg and 145 mg film-coated tablets. The 48 mg tablets are yellow, oval-shaped, film-coated tablets, whilst the 145 mg tablets are white to off-white, oval-shaped, film-coated tablets.

Approved indications

Fenofibrate-WGR 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-WGR is one 145 mg tablet. The 48 mg tablets are only recommended when a decreased dosage is required. Tablets should be swallowed whole with a glass of water and may be given at any time of the day, with or without food, although it is recommended that they be taken at the same time each day. Dosage reduction is required in patients with renal impairment. In moderate renal dysfunction, start with one 48 mg tablet once daily and may be increased to two 48 mg tablets daily only after evaluation of effects on renal function and lipid levels at the lower dose. In patients with severe renal dysfunction, fenofibrate-WGR is contraindicated.

Key safety warnings

Elevations in serum creatinine have been reported in patients on fenofibrate-WGR, which tend to return to baseline following discontinuation. It is recommended that creatinine is measured during the first 3 months after initiation of treatment and thereafter periodically. Fenofibrate-WGR has been associated with increases in serum transaminases, with the incidence appearing to be dose related. Baseline and ongoing monitoring of liver function should be performed every 3 months during the first 12 months of treatment and thereafter periodically. Therapy should be discontinued if AST and ALT levels increase to more than 3 times the upper limit of the normal range. There have been reports of elevations of creatine phosphokinase, myositis and myopathy associated with fenofibrate-WGR, and rhabdomyolysis has been reported rarely. Patients complaining of muscle pain, tenderness or weakness should have prompt medical evaluation, and if myositis is suspected or if CPK rises to ≥5 times the upper limit of normal, fenofibrate-WGR therapy should be withdrawn. The risk of serious muscle toxicity is increased if fenofibrate-WGR is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Fenofibrate-WGR may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated, and fenofibrate-WGR therapy should be discontinued if gallstones are found. In the FIELD trial, pulmonary embolism and deep vein thrombosis were observed at higher rates in the fenofibrate-WGR group than the placebo group, with deep vein thrombosis occurring in 1.4% of fenofibrate-WGR patients versus 1% of placebo patients, and pulmonary embolism in 1.1% versus 0.7% respectively.

Contraindications

Fenofibrate-WGR is contraindicated in children; patients with liver dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormality; patients with severe renal dysfunction; patients with existing gallbladder disease; co-administration with another fibrate; patients hypersensitive to fenofibrate or any excipients, and in cases of known photoallergy or phototoxic reactions during treatment with fibrates or ketoprofen; chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia; and patients allergic to peanuts, arachis oil, soya lecithin or related products due to risk of hypersensitivity reactions.

PBS listing

No information on PBS listing status is available in the provided sources.

Regulatory history

Fenofibrate-WGR 48 mg film-coated tablets (ARTG 442650) and 145 mg film-coated tablets (ARTG 442651) were first listed on the Australian Register of Therapeutic Goods on 21 May 2024.