Fezolinetant Dosage

Medically reviewed by Drugs.com. Last updated on Sep 13, 2023.

Usual Adult Dose for Postmenopausal Symptoms

Recommended dose: 45 mg orally once a day

Comments:

• Evaluate liver function prior to treatment initiation and as recommended.
• The benefit and duration of treatment should be periodically assessed based on the history and course of the vasomotor symptoms (VMS); no data available beyond 12 months.

Use: For the treatment of moderate to severe VMS associated with menopause

Renal Dose Adjustments

Mild or moderate renal dysfunction (estimated GFR greater than 30 mL/min/1.73 m2): No dose adjustment recommended
Severe renal dysfunction or end-stage renal disease (estimated GFR less than 30 mL/min/1.73 m2): Contraindicated

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended
Moderate or severe liver dysfunction (Child-Pugh B or C): Contraindicated

Precautions

The following product is subject to additional monitoring: Veoza

CONTRAINDICATIONS:

• Known hypersensitivity to either the active component or to any of the ingredients
• Concomitant use of moderate or strong CYP450 1A2 inhibitors
• Pre-existing Child-Pugh B or C chronic hepatic impairment
• Severe or end stage renal impairment (estimated GFR less than 30 mL/min/1.73 m2)

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:

• For oral use
• Before starting treatment, perform baseline liver function tests.
• Administer with or without food at about the same time each day.
• This drug should be given with liquid and swallowed whole; do not crush, cut, or chew tablets.
• Missed doses should be taken as soon as possible, unless the next scheduled dose is within 12 hours.

Storage requirements: Store below 30C.

Monitoring:

• Drug interactions: For potential use of CYP450 1A2 inhibitors (prior to and during therapy)
• General: For treatment benefit (periodically during therapy)
• Hepatic: Liver function tests (at baseline and at least once within first 3 months of therapy)

Patient advice:

• Read the Consumer Medicine Information.
• Understand that blood tests to evaluate liver function are required prior to therapy and then periodically.
• Report all medication and supplement use to your health care provider.
• Patients of childbearing potential: Notify a health care provider of a known or suspected pregnancy, or if breastfeeding.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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