VEOZA

What it is

VEOZA is a film-coated tablet containing 45 mg of fezolinetant for oral administration. Fezolinetant is a nonhormonal selective NK3 receptor antagonist that blocks neurokinin B (NKB) binding on kisspeptin/neurokinin B/dynorphin (KNDy) neurons to modulate neuronal activity in the thermoregulatory centre. This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information.

Approved indications

— Moderate to severe vasomotor symptoms (VMS) associated with menopause.

Dosing overview

The recommended dose of VEOZA is 45 mg once daily. VEOZA should be administered orally once daily at about the same time each day with or without food, taken with liquids, and should be swallowed whole. The benefit and duration of treatment with VEOZA should be periodically assessed based on the natural history and course of the vasomotor symptoms associated with menopause; no clinical data beyond a treatment period of 12 months are available.

Key safety warnings

Across the three phase 3 studies, elevations in serum alanine aminotransferase (ALT) levels at least 3 times the upper limit of normal (ULN) occurred in 2.1% of women receiving fezolinetant compared to 0.8% of women receiving placebo, and elevations in serum aspartate aminotransferase (AST) levels at least 3 times the ULN occurred in 1.0% of women receiving fezolinetant compared to 0.4% of women receiving placebo. In the post-marketing setting, cases of serious but reversible hepatotoxicity have been reported within 40 days of treatment, with patients experiencing transaminase elevations (greater than 10 times the ULN) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP), sometimes associated with signs or symptoms such as fatigue, pruritus, jaundice, dark urine, or abdominal pain. Baseline hepatic laboratory tests must be performed before initiating treatment; do not start VEOZA if ALT or AST is ≥ 2 × ULN or if total bilirubin is ≥ 2 × ULN, and perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months and 9 months after initiation of therapy.

Contraindications

VEOZA is contraindicated in patients with known hypersensitivity to fezolinetant or to any of the excipients in the formulation. Concomitant use of moderate or strong CYP1A2 inhibitors is contraindicated. VEOZA is contraindicated in patients with pre-existing Child-Pugh Class B (moderate) or Class C (severe) chronic hepatic impairment. VEOZA is contraindicated in patients with severe or end-stage renal impairment (eGFR < 30 mL/min/1.73 m²).

Regulatory history

VEOZA (fezolinetant 45 mg film-coated tablet) was first approved on 26 February 2024 and registered on the ARTG as entry 401401. In March 2025, the PBAC did not recommend VEOZA for listing on the PBS for moderate to severe menopause-related vasomotor symptoms.