Can fezolinetant be restarted with elevated transaminases?

Published

Do not start fezolinetant if alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is ≥ 2 × upper limit of normal (ULN) or if total bilirubin is ≥ 2 × ULN upper limit of normal (ULN) for the evaluating laboratory. Fezolinetant is contraindicated in women with known cirrhosis

  • Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury (including serum ALT, serum AST, serum alkaline phosphatase, and total and direct serum bilirubin) prior to fezolinetant initiation.1
  • 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).1
  • Astellas does not provide specific treatment recommendations on the management of transaminase elevation while on fezolinetant therapy beyond the guidance provided in the product label1, and has not specifically studied restarting treatment after discontinuation; treatment decisions are left to the clinical discretion of the prescriber based on institutional protocol, practice guidelines, and patient-specific characteristics and response.

  1. VEOZAH [package insert]. Northbrook, IL, USA: Astellas Pharma, Inc. Available at: https://www.astellas.com/us/system/files/veozah_uspi.pdf. 

find-my-msl

Find My MSL

Medical Science Liaisons are available to help answer your scientific questions.

submit

Submit an Inquiry

For any medical inquiries, please submit your question online to Astellas Medical Information or call or fax your inquiry.

Astellas Phone: 1-800-727-7003

Fax: 1-877-829-7942

adverse

Report an Adverse Event or Product Complaint

Report adverse events and product complaints to Astellas or FDA MedWatch.

Astellas Phone: 1-800-727-7003

FDA MedWatch: 1-800-FDA-1088

Hours: M–F, 8 AM–4:30 PM (CT)