Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use

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 and ALT and AST elevations

In a total of three phase III studies, 2.3% of patients treated with fezolinetant (corresponding to an incidence rate of 2.7 cases per 100 women-years adjusted for the duration of exposure) experienced increases in alanine aminotransferase (ALT) and/or or aspartate aminotransferase (AST) to values >3x the upper limit of normal range (ULN). With placebo, such increases were documented in 0.9% of patients (or 1.5 cases per 100 women-years). Cases with an increase in transaminases to values >5x ULN were rare.

Furthermore, cases of bilirubin elevation to >2x ULN were not observed. The transaminase elevations usually occurred within the first three months of treatment and were generally asymptomatic and, in most cases, reversible despite continued therapy. Fezolinetant has not been studied in patients with severe hepatic impairment (see section 4.2).


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 Driving

4.7         Effects on ability to drive and use machines

Fezolinetant has no or negligible influence on the ability to drive and use machines.