Fezolinetant
VEOZAH
What it isNeurokinin-3 receptor antagonist acting in hypothalamic thermoregulation; menopausal vasomotor symptoms.
Why this oneIt targets the hot-flash circuit without hormones, unlike estrogen therapy and off-label antidepressant options.
What limits itHepatotoxicity requires liver monitoring, and CYP1A2 inhibitors are contraindicated.
FDA-approved for
- menopausal hot flashes (2023)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Moderate–severe vasomotor symptoms of menopause | adult women | 45 mg QD | 45 mg QD |
Renal Contraindicated in severe renal impairment or ESRD.
Hepatic Contraindicated in known cirrhosis; do not start if AST/ALT or total bilirubin ≥2x ULN.
Instructions
- Take with or without food; swallow whole with liquids; do not cut, crush, or chew.
- Take at about the same time each day.
- Perform baseline hepatic labs, then follow-up monthly for 3 months, and at 6 and 9 months.
Contraindications
- Known cirrhosis
- Severe renal impairment or end-stage renal disease
- Concomitant use with CYP1A2 inhibitors
Cautions
- Hepatotoxicity / hepatic transaminase elevation — monitor LFTs
Adverse reactions
- Abdominal pain
- Diarrhea
- Insomnia
- Back pain
- Hot flush
- Hepatic transaminase elevation
Pregnancy No human data; not indicated in pregnancy; embryo-lethality at high doses in animals.
Lactation No data on presence in human milk.
⚠ BOXED WARNING
- Hepatotoxicity
Cost, est. cash$300–$2,500/month
Generic entry2034 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Fezolinetant ballicule
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