ARX-FENOFIBRATE

What it is

ARX-FENOFIBRATE is available in two strengths: 48 mg tablets and 145 mg tablets, each containing micronised fenofibrate. ARX-FENOFIBRATE is indicated as an adjunct to diet in the treatment of hypercholesterolaemia, types II, III, IV and V dyslipidaemia, and dyslipidaemia associated with type 2 diabetes.

Approved indications

— Hypercholesterolaemia — Type II dyslipidaemia — Type III dyslipidaemia — Type IV dyslipidaemia — Type V dyslipidaemia — Dyslipidaemia associated with type 2 diabetes

Dosing overview

The usual dose of fenofibrate is 1 × 145 mg. The 48 mg tablets are only recommended when a decreased dosage is required. Patients should never be administered any combination of the 48 mg tablet and the 145 mg tablet of fenofibrate. ARX-FENOFIBRATE 48 mg and 145 mg may be given at any time of the day, with or without food, but it is recommended that they be taken at the same time each day. In moderate renal dysfunction (eGFR between 30 mL/min/1.73 m² and 60 mL/min/1.73 m²), start with one ARX-FENOFIBRATE 48 mg tablet once daily. The dose may be increased to two ARX-FENOFIBRATE 48 mg tablets daily only after evaluation of the effects on renal function and lipid levels at the lower dose. In patients with severe renal dysfunction (eGFR < 30 mL/min/1.73 m²), fenofibrate is contraindicated.

Key safety warnings

Elevations in serum creatinine have been reported in patients on fenofibrate. These elevations tend to return to baseline following discontinuation of fenofibrate. It is recommended that creatinine is measured during the first 3 months after initiation of treatment and thereafter periodically. Treatment should be interrupted in case of an increase in creatinine levels > 50% of upper limit of normal. Fenofibrate at doses equivalent to 145 mg per day has been associated with increases in serum transaminases. When transaminase determinations were followed either after discontinuation of treatment or during continued treatment, a return to normal limits was usually observed. The incidence of increases in transaminases related to fenofibrate therapy appears to be dose related. Baseline and ongoing monitoring (every 3 months during the first 12 months of treatment and thereafter periodically) of liver function should be performed for the duration of fenofibrate therapy. Therapy should be discontinued if AST (SGOT) and ALT (SGPT) levels increase to more than 3 times the upper limit of the normal range. There have been reports of elevations (sometimes marked) of creatine phosphokinase (CPK), myositis and myopathy associated with fibrates as well as other systemically absorbed lipid modifying drugs. Rhabdomyolysis has also been reported rarely. Patients receiving fenofibrate and complaining of muscle pain, tenderness or weakness should have prompt medical evaluation for myositis, including serum creatinine level determination. If myositis is suspected or if CPK rises to ≥ 5 times the upper limit of normal, fenofibrate therapy should be withdrawn. In the FIELD trial, pulmonary embolus and deep vein thrombosis were observed at higher rates in the fenofibrate-treated group compared to placebo. For deep vein thrombosis, there were 48 events (1%) in the placebo group and 67 (1.4%) in the fenofibrate group, and for pulmonary embolus, there were 32 (0.7%) events in the placebo group and 53 (1.1%) in the fenofibrate group.

Contraindications

ARX-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/1.73 m²); 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 or arachis oil or soya lecithin or related products due to risk of hypersensitivity reactions.

Regulatory history

ARX-FENOFIBRATE fenofibrate 48 mg and 145 mg film-coated tablets were first listed on the Australian Register of Therapeutic Goods on 21 May 2024.