Veoza Special Precautions

Medical examination/consultation: Prior to the initiation or reinstitution of Veoza, a careful diagnosis should be made, and complete medical history (including family history) must be taken. During treatment, periodic check-ups must be carried out according to standard clinical practice.
Liver disease: Veoza is not recommended for use in individuals with Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment. Women with active liver disease or Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment have not been included in the clinical efficacy and safety studies with fezolinetant (see Dosage & Administration) and this information cannot be reliably extrapolated. The pharmacokinetics of fezolinetant has been studied in women with Child-Pugh Class A (mild) and B (moderate) chronic hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatotoxicity: Elevations in serum alanine aminotransferase (ALT) levels at least 3 times the upper limit of normal (ULN) occurred in 2.1% of women receiving fezolinetant compared to 0.8% of women receiving placebo. Elevations in serum aspartate aminotransferase (AST) levels at least 3 times the ULN occurred in 1.0% of women receiving fezolinetant compared to 0.4% of women receiving placebo (see Adverse Reactions). ALT and/or AST elevations were not accompanied by an increase in bilirubin (greater than two times the ULN, i.e., there were no cases of Hy's law) with fezolinetant. Women with ALT or AST elevations were generally asymptomatic. Transaminase levels returned to pre-treatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation.
In the post-marketing setting, cases of serious but reversible hepatotoxicity have been reported within the first few weeks of treatment. Patients have experienced transaminase elevations (greater than 10 times the ULN) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP), sometimes associated with signs or symptoms such as fatigue, pruritus, jaundice, dark urine, or abdominal pain.
Evaluate hepatic function (ALT, AST, ALP, and bilirubin) before initiating therapy. Do not initiate fezolinetant if ALT or AST is equal to or exceeds 2 times the ULN or if the total bilirubin is elevated (e.g., equal to or exceeds 2 times the ULN).
Patients should discontinue fezolinetant immediately and seek medical attention, including hepatic laboratory tests, if they experience signs or symptoms that may suggest hepatotoxicity such as new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale faeces, dark urine, or abdominal pain.
Follow-up evaluation of hepatic function is recommended monthly for the first three months of initiating fezolinetant and thereafter periodically based on clinical judgement.
Discontinue fezolinetant if: transaminase elevations are greater than 5 times the ULN; transaminase elevations are greater than 3 times the ULN and the total bilirubin level is greater than 2 times the ULN.
Exclude alternative causes of hepatic laboratory test elevations.
Known or previous breast cancer or oestrogen-dependent malignancies: Women undergoing oncologic treatment (e.g., chemotherapy, radiation therapy, anti-hormone therapy) for breast cancer or other oestrogen-dependent malignancies have not been included in the clinical studies. Therefore, Veoza is not recommended for use in this population as the safety and efficacy are unknown.
Women with previous breast cancer or other oestrogen-dependent malignancies and no longer on any oncologic treatment have not been included in the clinical studies. A decision to treat these women with Veoza should be based on a benefit-risk consideration for the individual.
Concomitant use of hormone replacement therapy with oestrogens (local vaginal preparations excluded): Concomitant use of fezolinetant and hormone replacement therapy with oestrogens has not been studied, and therefore concomitant use is not recommended.
Seizures or other convulsive disorders: Fezolinetant has not been studied in women with a history of seizures or other convulsive disorders. There were no cases of seizures or convulsive disorders during clinical studies. A decision to treat these women with Veoza should be based on a benefit-risk consideration for the individual.
Effects on ability to drive and use machines: Fezolinetant has no or negligible influence on the ability to drive and use machines.