What liver function tests are recommended before initiating veozah treatment?

Liver Tests Required Before Initiating Veozah Treatment

Before starting Veozah (fezolinetant) treatment, baseline hepatic laboratory tests must include serum ALT, AST, alkaline phosphatase (ALP), and total and direct bilirubin to evaluate hepatic function and potential injury. 1

Specific Requirements and Thresholds

Mandatory Pre-Treatment Testing

• Alanine aminotransferase (ALT)
• Aspartate aminotransferase (AST)
• Alkaline phosphatase (ALP)
• Total bilirubin
• Direct bilirubin

Critical Thresholds for Starting Treatment

• Do not initiate Veozah if:
  • ALT or AST ≥ 2× ULN (upper limit of normal)
  • Total bilirubin ≥ 2× ULN 1

Rationale for Liver Testing Requirements

Veozah has been associated with potential hepatotoxicity:

• In clinical trials, 2.3% of women receiving Veozah experienced elevations in serum transaminases (ALT/AST) >3× ULN compared to 0.9% with placebo 1
• Post-marketing reports have identified cases of drug-induced liver injury with elevations of ALT, AST, ALP, and total bilirubin occurring within 40 days of starting Veozah 1

Monitoring Schedule After Initiating Treatment

After starting Veozah, follow-up hepatic laboratory tests should be performed:

• Monthly for the first 3 months
• At 6 months
• At 9 months after initiation of therapy 1

Warning Signs Requiring Immediate Discontinuation

Patients should be advised to discontinue Veozah immediately and seek medical attention if they experience:

• New onset fatigue
• Decreased appetite
• Nausea or vomiting
• Pruritus or jaundice
• Pale feces or dark urine
• Abdominal pain 1

Criteria for Discontinuation During Treatment

Veozah must be discontinued if:

• Transaminase elevations are >5× ULN
• Transaminase elevations are >3× ULN and total bilirubin is >2× ULN 1

Common Pitfalls to Avoid

1. Inadequate baseline testing: Failing to obtain all required liver tests before starting treatment may miss pre-existing liver conditions that contraindicate Veozah use.

2. Overlooking contraindications: Veozah is contraindicated in women with known cirrhosis, regardless of liver test results 1.

3. Insufficient monitoring: Following the recommended monitoring schedule is essential as hepatotoxicity can develop after treatment initiation.

4. Delayed response to abnormalities: If transaminase elevations >3× ULN occur during treatment, more frequent follow-up hepatic laboratory tests should be performed until resolution 1.

By following these specific testing requirements before initiating Veozah treatment, clinicians can minimize the risk of hepatotoxicity and ensure appropriate patient selection for this therapy.