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Understanding What to monitor with Veozah: A Patient and Provider Guide

2 min read

The U.S. Food and Drug Administration (FDA) has issued a Boxed Warning for Veozah, emphasizing the risk of rare but serious liver injury. Therefore, understanding what to monitor with Veozah, particularly liver function and concerning symptoms, is paramount for patient safety.

Quick Summary

Veozah, a non-hormonal treatment for hot flashes, necessitates strict hepatic laboratory monitoring and symptom surveillance due to hepatotoxicity risks. Patients and healthcare providers must follow a specific testing schedule and be vigilant for signs of liver injury throughout therapy.

Key Points

  • Pre-Treatment Liver Screening: Baseline hepatic laboratory tests are mandatory before initiating Veozah to assess liver function.

  • Regular Follow-Up Bloodwork: A specific schedule of follow-up liver enzyme tests is required monthly for the first three months of treatment, then again at months 6 and 9.

  • Symptom Awareness is Critical: Patients should monitor for signs of liver injury and report them immediately.

  • Immediate Discontinuation for Severe Abnormalities: Veozah must be stopped if liver enzyme elevations reach specific high levels.

  • Review Medication Interactions: It is essential to screen for and avoid concomitant use with strong CYP1A2 inhibitors.

  • Assess Renal Function: Providers must check for severe kidney problems, as this condition contraindicates the use of Veozah.

In This Article

The Critical Importance of Hepatic Monitoring

Veozah, or fezolinetant, is a prescription medication for moderate to severe menopausal hot flashes. It acts as a neurokinin 3 (NK3) receptor antagonist in the brain to regulate body temperature. Due to a risk of liver injury, the FDA has included a Boxed Warning for Veozah, highlighting postmarketing cases of serious hepatotoxicity. Monitoring for liver issues is crucial and involves both lab tests and symptom reporting.

Required Hepatic Laboratory Testing

Your healthcare provider will order blood tests, including serum ALT, AST, ALP, and total and direct bilirubin, to monitor your liver function.

Testing Timeline Before starting Veozah, a baseline liver blood test is required. Treatment should not begin if certain liver enzyme levels are elevated. Follow-up tests are needed monthly for the first three months, then at month 6 and month 9. Additional tests are needed if symptoms of liver problems appear.

Discontinuation Criteria Veozah should be stopped immediately if transaminase levels exceed 5 times the upper limit of normal (ULN) or are more than 3 times ULN with total bilirubin above 2 times ULN. If transaminase levels are greater than 3 times ULN, more frequent testing is required.

Recognizing and Reporting Symptoms of Liver Injury

Patients should be vigilant for and report symptoms of liver injury promptly. Key symptoms include unusual fatigue, nausea, vomiting, decreased appetite, persistent itching, jaundice, dark urine, pale stools, or pain in the upper right abdomen.

Monitoring Other Aspects of Veozah Treatment

Other health factors beyond liver function also require attention during Veozah treatment.

Medication Interactions

Veozah is metabolized by the CYP1A2 enzyme. Taking it with moderate-to-strong CYP1A2 inhibitors can increase fezolinetant levels and side effect risks, and is contraindicated. Always provide a full list of medications and supplements to your doctor.

Renal Function

Veozah is eliminated through the kidneys. Severe renal impairment or end-stage renal disease is a contraindication. Kidney function should be assessed before starting treatment.

Comparison of Monitoring Types

Effective monitoring of Veozah therapy requires collaboration between the patient and healthcare team. The table below outlines their respective roles.

Monitoring Type Responsibility Frequency Purpose Action if Concern Arises
Hepatic Lab Testing Healthcare Provider Baseline, monthly for 3 months, then at 6 and 9 months, and symptom-based To detect liver injury early, even before symptoms appear Provider adjusts treatment, potentially discontinuing Veozah
Symptom Surveillance Patient Daily To catch subjective and early indicators of liver problems Patient contacts provider immediately; potential urgent care visit
Medication Review Provider and Patient Baseline and with any new medication/supplement To identify and avoid drug-drug interactions that affect Veozah levels Provider may suggest alternative medication
General Health & Side Effects Patient Ongoing To manage common side effects like abdominal pain, diarrhea, and insomnia Patient discusses management strategies with provider

Conclusion

Monitoring is a vital component of safe Veozah therapy, primarily focused on liver health. Providers are responsible for scheduled lab tests and screening for contraindications. Patients must actively monitor for and report concerning symptoms. For more detailed information, consult the official FDA-approved patient labeling.

Frequently Asked Questions

The most important things to monitor with Veozah are your liver function, checked with regular blood tests, and for any signs or symptoms of liver injury, such as jaundice, fatigue, and nausea.

You will need a baseline blood test before starting Veozah, monthly tests for the first three months, and then additional tests at months six and nine of your treatment.

You should watch for unusual fatigue, nausea, vomiting, itching, yellowing of the skin or eyes (jaundice), dark urine, pale stools, or pain in the upper abdomen. Report any of these symptoms to your doctor right away.

Yes, you should not take Veozah with medications that are strong inhibitors of the CYP1A2 enzyme, such as fluvoxamine or ciprofloxacin, as this can increase Veozah's levels and side effect risk. Discuss all your current medications and supplements with your healthcare provider.

If your liver enzyme levels are significantly elevated, your doctor may advise you to stop taking Veozah. If the levels are only moderately high, more frequent monitoring may be required until they return to normal.

Veozah is contraindicated in patients with severe kidney problems or end-stage renal disease because it is cleared from the body by the kidneys. Your healthcare provider will assess your kidney function before prescribing the medication.

There are no known direct interactions between Veozah and alcohol, but alcohol can worsen liver health and menopausal symptoms. Your doctor may advise you to limit or avoid alcohol consumption during treatment.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.