NUBEQA

What it is

NUBEQA contains darolutamide 300 mg per film-coated tablet. Darolutamide is a non-steroidal androgen receptor antagonist that binds with nanomolar affinity directly to the receptor ligand binding domain. Darolutamide competitively inhibits androgen binding, androgen receptor nuclear translocation and androgen receptor mediated transcription. This medicinal product is subject to additional monitoring in Australia.

Approved indications

NUBEQA is indicated for the treatment of patients with: — Non-metastatic castration resistant prostate cancer (nmCRPC) — Metastatic hormone-sensitive prostate cancer (mHSPC) — Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Dosing overview

The recommended dose is 600 mg (two film-coated tablets of 300 mg) darolutamide taken twice daily, equivalent to a total daily dose of 1200 mg. The tablets should be taken whole with food. NUBEQA should be continued until disease progression or unacceptable toxicity. Patients receiving NUBEQA should also receive a luteinizing hormone releasing hormone (LHRH) agonist or antagonist (GnRH analog) concurrently or should have had bilateral orchiectomy. When used in combination with docetaxel in mHSPC patients, the first of 6 cycles of docetaxel should be administered within 6 weeks after the start of NUBEQA treatment. For patients with moderate hepatic impairment (Child-Pugh B), the recommended dose is 300 mg twice daily, and for patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m²), the recommended dose is 300 mg twice daily.

Key safety warnings

The safety of darolutamide has not been characterised in patients with recent cardiovascular events. Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. In a pooled analysis of two randomised, placebo-controlled clinical trials, ischaemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Patients should be monitored for signs and symptoms of ischemic heart disease. Optimise management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidaemia. Seizure occurred in patients receiving NUBEQA. All seizure events in patients receiving NUBEQA occurred in patients without prior history of seizure. Cases of idiosyncratic drug induced liver injury (DILI) consisting of Grade ≥ 3 increases in ALT and/or AST, including with concomitant bilirubin ≥2x ULN, have been reported with NUBEQA. Time to onset ranged approximately from 1 month up to 12 months after initiation of NUBEQA. Liver function test abnormalities were reversible upon NUBEQA discontinuation. Monitor ALT and AST as per routine clinical practice. In case of liver function test abnormalities suggestive of idiosyncratic DILI, permanently discontinue NUBEQA.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. NUBEQA is contraindicated in women who are or may become pregnant. Based on its mechanism of action, NUBEQA may cause fetal harm when administered during pregnancy. Exposure of the fetus to an androgen receptor inhibitor through seminal transfer to the pregnant woman has to be avoided, as this could affect development of the fetus. Patients having sex with pregnant women should use a condom during and for three months after the last dose of NUBEQA.

PBS listing

The 300 mg tablet is listed on the PBS with 2 items under authority required restriction, at an ex-manufacturer price of A$3375.64 as of 2026-05-01.

Regulatory history

NUBEQA darolutamide 300 mg tablets in blister pack and bottle form were first listed on the ARTG on 26 February 2020. In March 2021, the PBAC did not recommend NUBEQA for non-metastatic castration resistant prostate cancer. In July 2021, the PBAC recommended NUBEQA for castration resistant prostate cancer. In November 2022, the PBAC deferred consideration of metastatic hormone sensitive prostate cancer in combination with docetaxel, and in May 2023, the PBAC recommended NUBEQA for metastatic hormone sensitive prostate cancer. An AusPAR was published on 17 March 2023 for the indication of metastatic hormone-sensitive prostate cancer in combination with docetaxel.