Veozah and the Importance of Liver Enzyme Monitoring
Veozah (fezolinetant) is a nonhormonal medication for moderate to severe hot flashes from menopause. It works by targeting NK3 receptors in the brain. While beneficial, it carries a risk of elevated liver enzymes and, rarely, serious liver injury.
Due to these risks, the FDA mandates a specific liver monitoring schedule for all patients. Healthcare providers must perform liver function tests before starting Veozah and regularly during treatment. This monitoring is vital as liver issues may not show symptoms initially.
The Mandatory Liver Enzyme Monitoring Schedule for Veozah
The FDA and manufacturer require a clear monitoring schedule to detect potential liver issues early.
Before Starting Veozah
Before starting Veozah, baseline liver tests, including ALT, AST, ALP, and bilirubin, are required. Treatment should not begin if baseline ALT or AST levels are two or more times the upper limit of normal (ULN), or if total bilirubin is two or more times ULN.
During Treatment
Following baseline testing, the monitoring schedule is as follows:
- Monthly for the first 3 months: Liver function tests are needed each month for the first three months.
- At 6 months: A follow-up test is necessary at six months.
- At 9 months: Another follow-up test is required at nine months.
What to Do if Liver Enzyme Levels Become Elevated
If liver enzyme levels rise, healthcare providers will take action based on the severity. More frequent testing is needed for transaminase levels over three times ULN (if total bilirubin is not also elevated) until levels normalize. Treatment must stop immediately if transaminase elevations are more than five times ULN, or more than three times ULN with total bilirubin over two times ULN.
Recognizing Signs and Symptoms of Liver Injury
Patients should watch for symptoms of liver injury and contact their doctor immediately if any occur. Early detection and stopping the medication can prevent serious damage.
Warning signs of liver injury include:
- New or unusual fatigue
- Nausea and vomiting
- Unusual itching (pruritus)
- Yellowing of the skin or eyes (jaundice)
- Light-colored stools
- Dark urine
- Pain or swelling in the upper right abdomen
Comparison of Veozah vs. Statin Liver Monitoring
The monitoring for Veozah differs from medications like statins, which have a less frequent schedule based on updated data.
| Feature | Veozah (Fezolinetant) | Statins (e.g., Atorvastatin) |
|---|---|---|
| Indication | Moderate to severe hot flashes due to menopause | High cholesterol |
| FDA Monitoring Schedule | Baseline, then monthly for the first 3 months, and again at months 6 and 9 | Baseline, then as clinically indicated |
| Monitoring Rationale | Mandatory due to risk of elevated liver enzymes and rare but serious liver injury | Routine monitoring no longer recommended; only test if clinically indicated or at risk |
| Monitoring Period | Specified intervals, especially in the first year | Less frequent, based on physician discretion |
| Required Baseline Test? | Yes, absolutely | Yes, recommended |
Conclusion
Adhering to the mandated liver enzyme monitoring schedule is essential for safe Veozah treatment. The schedule includes baseline testing, monthly checks for the first three months, and further tests at six and nine months. This allows for early detection of potential liver issues. Report any signs of liver injury to your doctor, who can provide necessary tests and guidance. Consult the FDA Drug Safety Communication for more details on Veozah and liver injury.
