Version July 2025
The FDA has issued a drug safety communication that Veozah (fezolinetant) can cause rare but serious liver injury based on a postmarketing case reported in a patient who developed symptomatic acute mixed hepatocellular cholestatic liver injury with elevated liver function tests within 40 days of starting fezolinetant, which resolved upon discontinuation. The FDA has updated the warnings of the prescribing information to include new recommendations for liver function test monitoring at baseline, during therapy, and in patients experiencing signs and symptoms of liver injury (eg, fatigue, nausea, vomiting, unusual itching, light-colored stools, jaundice, right upper abdominal pain). Patients should be advised to discontinue therapy and immediately contact their health care provider if they experience signs and symptoms of liver injury.
Further information can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due.
Hepatotoxicity has occurred with the use of fezolinetant in the postmarketing setting. Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start fezolinetant if either aminotransferase is ≥2 times the upper limit of normal (ULN) or if the total bilirubin is ≥2 times ULN for the evaluating laboratory. Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment. Advise patients to discontinue fezolinetant immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain). Discontinue fezolinetant if transaminase elevations are >5 times ULN, or if transaminase elevations are >3 times ULN and the total bilirubin level is >2 times ULN. If transaminase elevations >3 times ULN occur, perform more frequent follow-up laboratory tests until resolution.
Note: Perform LFTs prior to initiation; do not initiate therapy in patients with ALT, AST, and/or total bilirubin ≥2 times the ULN.
Vasomotor symptoms associated with menopause: Oral: 45 mg once daily.
Missed doses: If a dose is missed, administer the dose as soon as remembered; if there is <12 hours before the next scheduled dose, skip the missed dose and return to the regular schedule the following day.
GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR <30 mL/minute/1.73 m2: Use is contraindicated.
Hepatic impairment prior to treatment initiation:
Mild to moderate impairment (Child-Pugh class A or B): Use is contraindicated; increased exposure of fezolinetant has been reported.
Severe impairment (Child-Pugh class C): Use is contraindicated (has not been studied).
Acute hepatotoxicity during treatment: Note: Signs and symptoms of liver injury may include new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.
ALT or AST >3 times ULN: Evaluate liver transaminases more frequently until resolution.
ALT or AST >5 times ULN or ALT or AST >3 times ULN with total bilirubin >2 times the ULN or signs and symptoms of liver injury: Discontinue treatment immediately and institute appropriate medical attention.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Endocrine & metabolic: Hot flash (3%)
Gastrointestinal: Abdominal pain (4%), diarrhea (4%)
Hepatic: Increased serum transaminases (2%)
Nervous system: Insomnia (4%)
Neuromuscular & skeletal: Back pain (3%)
Postmarketing: Hepatic: Hepatotoxicity (including increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum bilirubin)
Known cirrhosis; severe renal impairment or end-stage renal disease; concomitant use with CYP1A2 inhibitors.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Hepatic transaminase elevation: Hepatic serum transaminase elevations (ie, ALT and AST) >3 times the ULN have occurred. Cases of fezolinetant-induced liver injury, usually occurring within 40 days of therapy initiation, were reported postmarketing and resolved with drug discontinuation. Elevations are typically asymptomatic and resolve with continued therapy, dose interruption, or discontinuation.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Veozah: 45 mg
No
Tablets (Veozah Oral)
45 mg (per each): $22.66
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Veozah: 45 mg
Oral: Administer at about the same time each day with liquids; administer with or without food. Swallow tablet whole; do not cut, crush, or chew.
Vasomotor symptoms associated with menopause: Treatment of moderate to severe vasomotor symptoms due to menopause.
Substrate of CYP1A2 (Major with inhibitors), CYP1A2 (Minor with inducers), CYP2C19 (Minor), CYP2C9 (Minor), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Aldesleukin: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
CYP1A2 Inhibitors (Moderate): May increase serum concentration of Fezolinetant. Risk X: Avoid
CYP1A2 Inhibitors (Strong): May increase serum concentration of Fezolinetant. Risk X: Avoid
CYP1A2 Inhibitors (Weak): May increase serum concentration of Fezolinetant. Risk X: Avoid
Diazoxide Choline: May increase serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk X: Avoid
Dinutuximab Beta: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Elranatamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Epcoritamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Filgotinib: May increase serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Glofitamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Leniolisib: May increase serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid
Mosunetuzumab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Pacritinib: May increase serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Primaquine: May increase serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk C: Monitor
Ritlecitinib: May increase serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Talquetamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Tarlatamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Teclistamab: May increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Fezolinetant is approved for moderate to severe vasomotor symptoms in postmenopausal patients.
It is not known if fezolinetant is present in breast milk.
LFTs (including ALT, AST, alkaline phosphatase, total and direct serum bilirubin) prior to initiation of therapy, monthly for the first 3 months then at 6 and 9 months; and when symptoms suggest liver injury (eg, nausea, vomiting, yellowing of the skin or eyes).
Neurokinin 3 (NK3) receptor antagonist that blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center.
Distribution: Vz/F: 189 L.
Protein binding: 51%.
Metabolism: Primarily by CYP1A2; CYP2C9 and CYP2C19 to a lesser extent.
Half-life elimination: 9.6 hours.
Time to peak: Median 1.5 (1 to 4) hours.
Excretion: Urine: 76.9% (1.1% as unchanged drug); feces: 14.7% (0.1% as unchanged drug).
Clearance: 10.8 L/hour.
