Updated Labeling for Veozah Includes Boxed Warning for Hepatotoxicity
In a significant update, the prescribing information for Veozah (fezolinetant), a medication designed to alleviate moderate to severe vasomotor symptoms associated with menopause, has been revised to include a boxed warning regarding the risk of hepatotoxicity. This change follows the Food and Drug Administration’s (FDA) evaluation of a postmarketing report that highlighted instances of serious liver injury linked to the drug.
Veozah operates as an oral neurokinin 3 receptor antagonist and is specifically indicated for managing symptoms such as hot flashes that can significantly impact the quality of life during menopause. The newly added boxed warning serves as a crucial alert for healthcare providers, emphasizing the need for thorough evaluation of hepatic function before initiating treatment with Veozah.
According to the updated labeling, healthcare providers must refrain from starting Veozah in patients if their aminotransferase levels are greater than or equal to two times the upper limit of normal (ULN), or if the total bilirubin level is equal to or exceeds two times the ULN as determined by the evaluating laboratory.
For patients who are prescribed Veozah, the guidelines stipulate that hepatic laboratory testing should be performed monthly during the initial three months of treatment, followed by evaluations at six months and nine months. If a patient exhibits transaminase elevations exceeding five times the ULN, or if there are elevations greater than three times the ULN along with total bilirubin levels above two times the ULN, discontinuation of the medication is warranted. Additionally, more frequent monitoring is advised for patients showing transaminase elevations greater than three times the ULN.
Patients receiving Veozah should also be informed about the signs and symptoms indicative of liver injury. These symptoms may include new onset fatigue, loss of appetite, nausea, vomiting, itching, jaundice (yellowing of the skin and eyes), pale stools, dark urine, or abdominal discomfort. Immediate discontinuation of the medication is advised should any of these symptoms arise.
In a statement regarding the label update, Sara Jacobson, Director of Astellas Therapeutic Area Communications, emphasized the importance of the revised warning. She stated, “In the case of this label update, the prominence of the already available warning on hepatotoxicity has been increased through the boxed warning. It is important to note that the overall benefit-risk of Veozah has not changed and remains positive, but we want to further ensure that patients and healthcare providers are aware of the potential side effects of Veozah, and the hepatic laboratory testing, as it relates to its benefit to help reduce moderate to severe vasomotor symptoms due to menopause.”
It is also critical to note that Veozah is contraindicated in women who have known cirrhosis, severe renal impairment, end-stage renal disease, or those who are taking concomitant CYP1A2 inhibitors. This contraindication is essential to prevent adverse effects and ensure patient safety while using the medication.
As the medical community continues to prioritize patient safety and effective treatment options for menopause-related symptoms, the updates to Veozah’s labeling aim to enhance awareness and monitoring of potential liver-related risks associated with its use.
