XENICAL

What it is

XENICAL is available as hard gelatin capsules containing 120 mg of orlistat. Orlistat is a potent, specific and reversible long-acting inhibitor of gastrointestinal lipases, which are required for the systemic absorption of dietary triglycerides. XENICAL selectively inhibits gastrointestinal lipase activity within the gastrointestinal tract and prevents the absorption of 30% of dietary fat, thus producing a weight-loss effect.

Approved indications

— Treatment of obese patients with a body mass index (BMI) ≥ 30. — Treatment of overweight patients with a BMI ≥ 27 in the presence of other risk factors, in conjunction with a mildly hypocaloric diet.

Dosing overview

The recommended oral dose of XENICAL is one 120 mg capsule with each main meal, during or up to one hour after the meal. If a meal is missed or contains no fat, the dose may be omitted. Doses above 120 mg three times daily have not been shown to provide additional benefit.

Key safety warnings

The possibility of experiencing gastrointestinal events may increase when XENICAL is taken with a diet high in fat (a diet high in fat would contain more than 30% calories from fat, which equates to more than 67 g fat). Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal events. Because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counselled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. The supplement should be taken at least 2 hours before or after the administration of XENICAL, such as bedtime. Cases of rectal bleeding have been reported with XENICAL. Prescribers should investigate further in case of severe and/or persistent symptoms. Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur. The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine. The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes to renal failure. This risk is increased in patients with underlying chronic kidney disease and/or volume depletion.

Contraindications

XENICAL is contraindicated in patients with hypersensitivity to orlistat or to any of the excipients in the capsule; pancreatic enzyme deficiency or chronic pancreatitis and major gastrointestinal surgery; chronic malabsorption syndrome; cholestasis; and during pregnancy or breastfeeding.

PBS listing

XENICAL capsule 120 mg is listed on the PBS. There is 1 PBS item with authority required restriction. The ex-manufacturer price is A$113.08.

Regulatory history

XENICAL orlistat 120 mg capsule blister pack was first listed on the Australian Register of Therapeutic Goods on 11 April 2000.