Drug Detail:Fezolinetant (Fezolinetant)
Drug Class: Miscellaneous central nervous system agents
Usual Adult Dose for Postmenopausal Symptoms
Recommended dose: 45 mg orally once a day
Comments:
- Evaluate liver function prior to treatment initiation and periodically as recommended.
Use: For the treatment of moderate to severe vasomotor symptoms due to menopause
Renal Dose Adjustments
- Mild to Moderate Renal Impairment (estimated GFR 30 to less than 90 mL/min/m2): No dose adjustment recommended
- Severe Renal Impairment (estimated GFR 15 to less than 30 mL/min/m2): Contraindicated
- End-stage Renal Disease (estimated GFR less than 15 mL/min/m2): Contraindicated
Liver Dose Adjustments
- Mild to Moderate Liver Dysfunction (Child-Pugh Class A or B): Data not available
- Severe Liver Dysfunction (Child-Pugh Class C): Unknown
- Patients with cirrhosis: Contraindicated
Precautions
CONTRAINDICATIONS:
- Patients with known cirrhosis
- Patients with severe renal impairment or end-stage renal disease
- Concomitant use of CYP450 1A2 inhibitors
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take with liquid and swallow whole; do not crush, cut, or chew tablets.
- May be taken with or without food.
- Administer at approximately the same time each day.
- Missed doses should be taken as soon as possible unless next scheduled dose is within 12 hours.
Storage requirements:
- Store at 20C to 25C (68F to 77F) with excursions permitted to 15C to 30C (59F to 86F).
Monitoring:
- Prior to treatment initiation, evaluate hepatic function including ALT, AST, and bilirubin (total and direct).
- After starting therapy, assess liver function periodically at 3 months, 6 months, and 9 months or when clinically indicated to evaluate symptoms of liver injury.
- Review renal function to ensure estimated GFR maintained greater than 30 mL/min/m2.
- Monitor for potential drug interactions before and during therapy.
Patient advice:
- Read the FDA-approved patient labeling (Medication Guide).
- Do not take this medication if you have cirrhosis, severe kidney problems, or kidney failure.
- Blood tests to evaluate liver function are required prior to treatment and then periodically.
- Monitor for symptoms of liver injury including nausea, vomiting, or yellowing of skin or eyes.
- Report all medication and supplement use to your healthcare provider.
