AUSGEM

What it is

AUSGEM is a medicine containing 600 mg of gemfibrozil as the active ingredient. It is presented as a 19 mm x 9.2 mm deep convex, white, film coated oval shaped tablet.

Approved indications —

Severe hypertriglyceridaemia (Type IV and V) in patients who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. — Dyslipidaemia associated with diabetes. — Reduction of risk of coronary heart disease in patients with Type IIa and IIb hypercholesterolaemia. AUSGEM is indicated as an adjunct to diet and other therapeutic measures.

Dosing overview

The recommended dose for adults is 600 mg twice daily (total daily dose 1200 mg) administered one half hour before the morning and evening meal. For patients who cannot tolerate AUSGEM when given half an hour before food, it may be taken with food, although the bioavailability of gemfibrozil is higher when administered half an hour before food.

Key safety warnings

There have been reports of myositis, myopathy and markedly elevated creatine phosphokinase associated with gemfibrozil, and rhabdomyolysis has also been reported rarely. Muscle damage must be considered in any patient presenting with diffuse myalgia, muscle tenderness and/or marked increase in muscle CPK levels (>5x ULN); under these conditions treatment must be discontinued. Both clofibrate and gemfibrozil may increase cholesterol excretion into the bile leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. AUSGEM therapy should be discontinued if gallstones are found. The concomitant administration of gemfibrozil with simvastatin is contraindicated. There have been reports of severe myositis with markedly elevated creatine kinase and myoglobinuria (rhabdomyolysis) when gemfibrozil and HMG-CoA reductase inhibitors were used concomitantly. In most subjects who have had an unsatisfactory lipid response to either drug alone, the possible benefit of combined therapy with HMG-CoA reductase inhibitors and gemfibrozil does not outweigh the risks of severe myopathy, rhabdomyolysis, and acute renal failure. Abnormal liver function tests have been observed occasionally during gemfibrozil administration. They are usually reversible when gemfibrozil is discontinued. Therefore, periodic liver function studies are recommended and AUSGEM therapy should be terminated if abnormalities persist.

Contraindications

AUSGEM is contraindicated in patients with hypersensitivity to gemfibrozil or any of the excipients in the formulation, hepatic dysfunction including primary biliary cirrhosis, severe renal dysfunction, pregnancy or lactation, pre-existing gallbladder or biliary tract disease including gallstones, previous history of photoallergy or phototoxic reaction during treatment with fibrates, and Type I hyperlipoproteinaemia. Concomitant use with simvastatin, repaglinide, or dasabuvir is also contraindicated.

PBS listing

AUSGEM 600 mg tablets are listed on the PBS with an ex-manufacturer price of A$9.21 and restriction type of restricted and unrestricted.

Regulatory history

AUSGEM received ARTG registration on 16 December 1997 under licence category RE.