APO-ANASTROZOLE

What it is

APO-ANASTROZOLE is a tablet containing anastrozole . The 1 mg formulation is a white, round, biconvex film coated tablet .

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 tablet (1 mg) to be taken orally once daily . For early breast cancer, the recommended duration of treatment should be five years . For patients being switched to APO-ANASTROZOLE from tamoxifen, the switch should occur after completion of two to three years of tamoxifen therapy .

Key safety warnings

APO-ANASTROZOLE lowers circulating estrogen 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 . The use of anastrozole was found to be associated with tendonitis and tenosynovitis in randomised controlled trials, with tendon rupture found to be 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 with APO-ANASTROZOLE . APO-ANASTROZOLE is not recommended for use in children or in premenopausal women, as safety and efficacy have not been established in these groups of patients .

Contraindications

APO-ANASTROZOLE must not be administered during pregnancy or lactation . Known hypersensitivity to the active substance or to any of the excipients is a contraindication .

PBS listing

The 1 mg tablet strength is listed on the PBS with 2 items at a restricted authority level, with an ex-manufacturer price of A$6.15 .

Regulatory history

APO-ANASTROZOLE (anastrozole 1 mg film-coated tablet) was first listed on the ARTG on 25 February 2016 .