Fezolinetant

Fezolinetant
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]

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Overview

Fezolinetant is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of moderate to severe vasomotor symptoms due to menopause.. Common adverse reactions include abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Fezolinetant is used to treat moderate and severe vasomotor symptoms due to menopause.

The recommended dosage is 45 mg administered orally as a tablet, once daily with or without meal. Always perform blood work to evaluate for hepatic impairment/failure prior to initiation of the treatment and follow up with blood workup every 3 months, 6 months and 9 months after initiating the therapy.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Fezolinetant FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

• Known history of cirrhosis

• Known history of Severe renal impairment or end-stage renal disease

• Concomitant use with CYP1A2 inhibitors

Warnings

Elevation of Hepatic transaminases

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Fezolinetant Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Fezolinetant Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Fezolinetant Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Fezolinetant in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fezolinetant in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fezolinetant during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fezolinetant in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Fezolinetant in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Fezolinetant in geriatric settings.

Gender

There is no FDA guidance on the use of Fezolinetant with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fezolinetant with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fezolinetant in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fezolinetant in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fezolinetant in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fezolinetant in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Fezolinetant Administration in the drug label.

Monitoring

There is limited information regarding Fezolinetant Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Fezolinetant and IV administrations.

Overdosage

There is limited information regarding Fezolinetant overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Fezolinetant Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Fezolinetant Mechanism of Action in the drug label.

Structure

There is limited information regarding Fezolinetant Structure in the drug label.

Pharmacodynamics

There is limited information regarding Fezolinetant Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Fezolinetant Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Fezolinetant Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Fezolinetant Clinical Studies in the drug label.

How Supplied

There is limited information regarding Fezolinetant How Supplied in the drug label.

Storage

There is limited information regarding Fezolinetant Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Fezolinetant Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Fezolinetant interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Fezolinetant Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Fezolinetant Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.