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Neurokinin-3 receptor antagonist Pregnancy: No data on use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or adverse maternal/fetal outcomes. In animal embryo-fetal studies, embryo-lethality occurred at high doses above the human therapeutic dose in rats and rabbits, but no teratogenicity was observed; delayed parturition, embryo-lethality and delayed male reproductive maturation occurred in rat pre-/post-natal studies at doses above the human therapeutic dose.

Fezolinetant

Brand names: Veoza

An oral neurokinin-3 (NK3) receptor antagonist used to treat moderate-to-severe vasomotor symptoms (hot flushes) associated with the menopause.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 45 mg
Route: Oral
Frequency: Once daily, at about the same time each day, with or without food
US label §2.1 Recommended Dosage: 'Take a single 45 mg VEOZAH tablet orally once daily with or without food.' Take with liquids and swallow whole; do not cut, crush or chew tablets. Missed dose: administer as soon as possible unless there is less than 12 hours before the next scheduled dose, then return to the regular schedule the following day. HEPATIC MONITORING (label §2.1): perform baseline hepatic laboratory tests (ALT, AST, ALP, total and direct bilirubin) before initiating; do NOT start if ALT or AST is at or above 2 x ULN or if total bilirubin is at or above 2 x ULN. While on treatment, perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months and at 9 months after initiation, or whenever signs or symptoms suggest liver injury. Advise patients to discontinue immediately and seek medical attention (including hepatic laboratory tests) for new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine or abdominal pain. Paediatric: 'The efficacy and safety of VEOZAH in individuals less than 18 years of age have not been established.' Geriatric: insufficient numbers of women over 65 studied to determine whether response differs. NOTE: no UK SPC (eMC) was available in the bundle — this dose is taken from the US prescribing information and must be verified against current UK labelling.

Dose adjustments

Renal

Contraindicated in severe renal impairment or end-stage renal disease (US label §4, §8.6). No graded renal dose adjustment is stated in the fetched label.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known cirrhosis
  • Severe renal impairment or end-stage renal disease
  • Concomitant use with CYP1A2 inhibitors

Side effects

  • Abdominal pain
  • Diarrhoea
  • Insomnia
  • Back pain
  • Hot flush
  • Hepatic transaminase elevation (ALT and/or AST greater than 3 x ULN in 2.3% vs 0.9% placebo); postmarketing hepatotoxicity and jaundice reported

Interactions

  • CYP1A2 inhibitors (weak, moderate or strong) — fezolinetant is a CYP1A2 substrate; concomitant use increases fezolinetant Cmax and AUC and is contraindicated

Clinical monograph

How it works

It blocks neurokinin B signalling at NK3 receptors on hypothalamic thermoregulatory neurons (KNDy neurons), helping to restore temperature control without using hormones.

Prescribing in practice

  • Hepatotoxicity has been reported, so liver function must be checked before starting and monitored during treatment, with the drug stopped if liver injury is suspected.
  • Contraindicated in known cirrhosis or significant hepatic impairment and avoided with strong CYP1A2 inhibitors.
  • It is a non-hormonal option, useful where oestrogen is unsuitable, but is not a contraceptive.

Monitoring

Monitor liver function before treatment and at intervals during therapy, advising patients to report symptoms of liver injury.

Counselling the patient

  • Attend for the recommended blood tests to check your liver.
  • Report nausea, vomiting, abdominal pain, dark urine or yellowing of the skin or eyes promptly.
  • This treats hot flushes but does not provide contraception.

Evidence & guidelines

Efficacy for menopausal vasomotor symptoms was demonstrated in the SKYLIGHT randomised controlled trial programme.

Reference: NICE TA982; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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