ARX-LETROZOLE

What it is

ARX-LETROZOLE is letrozole, available as coated tablets containing 2.5 mg letrozole. It is a non-steroidal aromatase inhibitor used as an antineoplastic agent.

Approved indications

— Treatment of postmenopausal women with hormone receptor positive breast cancer.

Dosing overview

The recommended dose of letrozole tablets is one 2.5 mg tablet daily. In the adjuvant setting, treatment should continue for 5 years or until tumour relapse occurs, whichever comes first. In patients with metastatic disease, treatment with letrozole should continue until tumour progression is evident.

Key safety warnings

Osteoporosis and bone fractures have been reported with the use of letrozole, and monitoring of overall bone health is recommended during treatment. The use of letrozole was found to be associated with tendonitis and tenosynovitis of uncommon occurrence, and tendon rupture of rare occurrence. In patients whose menopausal status is unclear, luteinising hormone, follicle-stimulating hormone and/or oestradiol levels should be measured before initiating treatment, and only women of postmenopausal endocrine status should receive letrozole. Physicians should discuss the necessity of adequate contraception with women who have the potential to become pregnant, including women who are perimenopausal or who recently became postmenopausal, until their postmenopausal status is fully established.

Contraindications

ARX-LETROZOLE is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, premenopausal endocrine status, pregnancy, and lactation.

PBS listing

ARX-LETROZOLE is not listed on the PBS.

Regulatory history

ARX-LETROZOLE letrozole 2.5 mg film-coated tablet was first listed on the Australian Register of Therapeutic Goods on 17 December 2018.