Liver Function Monitoring for Veozah (Fezolinetant)
Patients taking Veozah require baseline liver function testing before initiation, then monthly monitoring for the first 3 months, followed by testing at 6 months and 9 months after starting therapy. 1
Baseline Requirements
- Do not start Veozah if either aminotransferase (ALT or AST) is ≥2× upper limit of normal (ULN) or if total bilirubin is ≥2× ULN 1
- Baseline hepatic laboratory tests must evaluate for both hepatic function and injury before beginning treatment 1
Standard Monitoring Schedule
- Monthly liver function tests for the first 3 months after initiation 1
- Testing at 6 months after initiation 1
- Testing at 9 months after initiation 1
- Additional testing should be performed whenever signs or symptoms suggest liver injury 1
Management of Elevated Transaminases
Discontinue Veozah immediately if:
- Transaminase elevations are >5× ULN 1
- Transaminase elevations are >3× ULN and total bilirubin is >2× ULN 1
For transaminase elevations >3× ULN (but not meeting discontinuation criteria):
- Perform more frequent follow-up hepatic laboratory tests until resolution 1
Warning Signs Requiring Immediate Action
Advise patients to discontinue Veozah immediately and seek medical attention including hepatic laboratory tests if they experience: 1
- New onset fatigue
- Decreased appetite
- Nausea or vomiting
- Pruritus (itching)
- Jaundice (yellowing of eyes or skin)
- Pale feces
- Dark urine
- Abdominal pain
Contraindications Related to Liver Disease
- Known cirrhosis is an absolute contraindication to Veozah use 1
- The drug carries a boxed warning specifically for hepatotoxicity, as cases have occurred in the postmarketing setting 1
Clinical Context
This intensive monitoring schedule reflects the serious hepatotoxicity risk associated with Veozah. The monthly monitoring during the first 3 months captures the critical window when drug-induced liver injury most commonly manifests, as most cases of drug-induced hepatotoxicity occur within the first 2-24 weeks of therapy 2. The extended monitoring at 6 and 9 months provides additional safety surveillance beyond the highest-risk period 1.