ARIMIDEX

What it is

ARIMIDEX is anastrozole, supplied as tablets containing 1 mg of the active ingredient.

Approved indications

— Adjuvant treatment of early breast cancer in postmenopausal women with estrogen/progesterone receptor positive disease. — First line treatment of advanced breast cancer in postmenopausal women with estrogen/progesterone receptor positive disease. — Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.

Dosing overview

The recommended dose is one 1 mg tablet taken orally once daily. For early breast cancer, the recommended duration of treatment is five years. For patients being switched from tamoxifen to ARIMIDEX, the switch should occur after completion of two to three years of tamoxifen therapy.

Key safety warnings

ARIMIDEX lowers circulating oestrogen levels and may cause a reduction in bone mineral density with a possible consequent increased risk of fracture. Women with osteoporosis or at risk of osteoporosis should have their bone mineral density formally assessed by bone densitometry at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis should be initiated and monitored as appropriate. ARIMIDEX has been found to be associated with tendonitis and tenosynovitis in randomised controlled trials, with tendon rupture as a potential risk. Tendonitis and tenosynovitis were estimated to be of uncommon occurrence, and tendon rupture of rare occurrence. Patients should be monitored for signs and symptoms of tendon disorders during treatment. ARIMIDEX is not recommended for use in children or in premenopausal women, as safety and efficacy have not been established in these groups.

Contraindications

ARIMIDEX must not be administered during pregnancy or lactation. It is contraindicated in patients with known hypersensitivity to anastrozole or to any of the excipients.

PBS listing

Information regarding PBS listing, item numbers, restriction type, and ex-manufacturer price is not contained in the provided source documents.

Regulatory history

ARIMIDEX (anastrozole 1 mg tablets) was first registered on the ARTG on 17 December 1996.