ERLYAND

What it is

ERLYAND is a medicine containing apalutamide . It is available as 60 mg and 240 mg film-coated tablets . Apalutamide is an orally administered androgen receptor inhibitor that binds directly to the ligand-binding domain of the androgen receptor, prevents androgen receptor nuclear translocation, inhibits DNA binding, and impedes androgen receptor-mediated transcription .

Approved indications —

Metastatic castration-sensitive prostate cancer (mCSPC) — Non-metastatic, castration-resistant prostate cancer (nmCRPC)

Dosing overview

The recommended dose of ERLYAND is 240 mg (one 240 mg tablet or four 60 mg tablets) administered orally once daily . Patients should concurrently receive a gonadotropin-releasing hormone (GnRH) analogue, unless they have had a bilateral orchiectomy . ERLYAND tablets should be administered orally once daily, with or without food .

Key safety warnings

Ischaemic cardiovascular events and ischaemic cerebrovascular disorders, including events leading to death, occurred in patients receiving ERLYAND . Patients should be monitored for signs and symptoms of ischaemic heart disease, and cardiovascular risk factors such as hypertension, diabetes, or dyslipidaemia should be optimised . Fractures occurred in patients receiving ERLYAND. Patients should be evaluated for fracture risk and monitored and managed according to established treatment guidelines, with consideration of bone-targeted agents . Falls, including events leading to death, occurred in patients receiving ERLYAND with increased frequency in the elderly. Patients should be evaluated for fall risk . Seizure occurred in patients receiving ERLYAND. ERLYAND must be permanently discontinued in patients who develop a seizure during treatment . Hypothyroidism occurred in patients receiving ERLYAND, more commonly in those already receiving thyroid replacement therapy. Initiation or adjustment of thyroid replacement therapy may be required . Rare postmarketing cases of severe cutaneous adverse reactions (including drug reaction with eosinophilia and systemic symptoms and Stevens Johnson syndrome/toxic epidermal necrolysis), which can be life-threatening or may lead to death, have been reported with androgen receptor inhibitors including ERLYAND . Postmarketing cases of interstitial lung disease, including fatal cases, have been observed in patients treated with anti-androgens, including apalutamide. In case of acute onset and unexplained worsening of pulmonary symptoms, treatment should be interrupted pending investigation, and if interstitial lung disease is diagnosed, apalutamide should be discontinued .

Contraindications

ERLYAND is contraindicated in women who are or may become pregnant .

PBS listing

ERLYAND 60 mg tablets are listed on the PBS with authority required restriction at an ex-manufacturer price of A$3553.30 .

Regulatory history

The 60 mg tablet was first approved on 05 July 2018 and the 240 mg tablet on 28 February 2024 . The TGA approved registration of ERLYAND on 4 July 2018 for the treatment of non-metastatic, castration-resistant prostate cancer following a Priority Review pathway and the ACSS Consortium's NCE Work Sharing pilot . In November 2021, the PBAC recommended ERLYAND for castration-resistant prostate cancer with no distant metastases on conventional imaging . In July 2022, the PBAC recommended ERLYAND for metastatic hormone-sensitive prostate cancer . This medicinal product is subject to additional monitoring in Australia .