- Details
- Description
Packaging Size:
30t/bottle
Strength:
45mg
Composition:
Fezolinetant
Treatment:
Hot Flashes (vasomotor symptoms)
Form:
Tablet
Brand:
LuciFezo
Quantity Unit:
45mg*30t/Box
Manufacturer:
Lucius Pharmaceuticals (Lao) Co.,Ltd
About Fezolinetant
Fezolinetant is a medication used for the treatment of hot flashes (vasomotor symptoms) due to menopause.It is a small-molecule, orally active, selective neurokinin-3 (NK3) receptor antagonist which is under development by for the treatment of sex hormone-related disorders.
Menopausal Vasomotor Symptoms
Indicated for treatment of moderate-to-severe vasomotor symptoms (VMS) caused by menopause
45 mg PO qDay
Dosage Modifications
Renal impairment
- Mild or moderate (eGFR 30-89 mL/min/1.73 m2): No dose adjustment required
- Severe (eGFR 15-29 mL/min/1.73 m2 or end-stage renal disease [ESRD]): Contraindicated
Hepatic impairment
-
At baseline
- ALT or AST ≥2x ULN or if total bilirubin elevated (eg, ≥2x ULN): Do not start therapy
- Mild or moderate (Child-Pugh A or B): Increased systemic exposure observed; no recommendations listed in prescribing information
- Severe (Child-Pugh C): Not studied
-
Treatment-related toxicity
ALT/AST >5x ULN OR ALT/AST >3x ULN and total bilirubin >2x ULN: Discontinue
Dosing Considerations
Monitoring
-
Before initiating
- Obtain liver function tests (LFTs) including ALT/AST, alkaline phosphatase, and total and direct bilirubin
- May initiate if baseline hepatic transaminases <2x ULN and total bilirubin is normal
-
During treatment
- Monitor LFTs monthly for the first 3 months, at 6 months, and 9 months after starting therapy
- Perform more frequent LFT monitoring (until resolution) if ALT/AST >3x ULN occur
