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Veozah
fezolinetant
Black Box Warnings .
Hepatotoxicity Risk
hepatotoxicity has occured; monitor LFTs before tx start, do not start if ALT or AST >2x ULN or if bilirubin >2x ULN; monitor LFTs monthly for 1st 3mo, then at 6mo and 9mo after tx start; D/C immediately if liver injury s/sx (new onset fatigue, appetite decr, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, abdominal pain), if ALT or AST >5x ULN, or if AST or ALT >3x ULN and bilirubin >3x ULN; if AST or ALT >3x ULN, monitor LFTs more frequently until resolution
Adult Dosing .
Dosage forms: TAB: 45 mg
vasomotor sx, mod-severe menopausal
- [45 mg PO qd]
- Info: do not cut/crush/chew tab
renal dosing
- [see below]
- eGFR <30: contraindicated
- HD/PD: not defined
hepatic dosing
- [see below]
- cirrhosis: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- cirrhosis
- ALT or AST >2x ULN
- bilirubin >2x ULN
- eGFR <30
Drug Interactions .
Overview
fezolinetant
NK-3 antagonist
- CYP1A2 substrate
Contraindicated
- acyclovir
- allopurinol
- caffeine
- caffeine citrate
- cannabidiol
- cannabis
- capmatinib
- cimetidine
- ciprofloxacin
- danshen
- deferasirox
- diazoxide
- disulfiram
- echinacea
- efavirenz
- enasidenib
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- famotidine
- fexinidazole
- fluvoxamine
- ginseng, Asian
- givosiran
- glecaprevir
- interferon beta 1a
- interferon beta 1b
- methoxsalen
- mexiletine
- obeticholic acid
- osilodrostat
- pacritinib
- peginterferon alfa 2a
- pentoxifylline
- pibrentasvir
- propafenone
- propranolol
- ritlecitinib
- rucaparib
- safinamide
- stiripentol
- valacyclovir
- vemurafenib
- verapamil
- viloxazine
- zileuton
Adverse Reactions .
Serious Reactions
- hepatotoxicity
Common Reactions
- abdominal pain
- diarrhea
- insomnia
- back pain
- hot flashes
- ALT or AST elevated
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, then at 1mo, 2mo, 3mo, 6mo, and 9mo after tx start
Pregnancy/Lactation .
Pregnancy
Clinical Summary
N/A; drug unlikely to be used during pregnancy based on indication
Lactation
Clinical Summary
N/A; drug unlikely to be used while breastfeeding based on indication
Pharmacology .
Metabolism: liver; CYP450: 1A2 (primary), 2C9, 2C19 substrate
Excretion: urine 76.9% (1.1% unchanged), feces 14.7% (0.1% unchanged); Half-life: 9.6h
Subclass: Neurokinin 3 Receptor Antagonists
Mechanism of Action
selectively antagonizes neurokinin 3 receptor on kisspeptin/neurokinin B/dynorphin (KNDy) neuron, modulating neuronal activity in thermoregulatory center
Formulary .
No Formulary Selected
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