Veoza

Posology The recommended dose is 45 mg once daily. Benefit of long-term treatment should be periodically assessed since the duration of VMS can vary by individual. Missed dose If a dose of Veoza is missed or not taken at the usual time, the missed dose should be taken as soon as possible, unless there is less than 12 hours before the next scheduled dose.

Individuals should return to the regular schedule the following day. Elderly Fezolinetant has not been studied for safety and efficacy in women initiating Veoza treatment over 65 years of age. No dose recommendation can be made for this population.

2). Veoza is not recommended for use in individuals with Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment. 2). 2). 73 m2) renal impairment. 2). Paediatric population There is no relevant use of Veoza in the paediatric population for the indication of moderate to severe VMS associated with menopause.

Method of administration Veoza should be administered orally once daily at about the same time each day with or without food and taken with liquids. Tablets are to be swallowed whole and not broken, crushed, or chewed due to the absence of clinical data under these conditions.

0%). 6 There were no serious adverse reactions reported at an incidence greater than 1% across the total study population. On fezolinetant 45 mg, four serious adverse reactions were reported. 1%). 2%). Tabulated list of adverse reactions The safety of fezolinetant has been studied in 2203 women with VMS associated with menopause receiving fezolinetant once daily in phase 3 clinical studies.

Adverse reactions observed during clinical studies and from spontaneous reporting are listed below by frequency category in each system organ class. Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); and not known (cannot be estimated from the available data).

Table 1. Adverse reactions for fezolinetant 45 mg MedDRA system organ class (SOC) Frequency category Adverse reaction Psychiatric disorders Common Insomnia Gastrointestinal disorders Common Diarrhoea, Abdominal pain Hepatobiliary disorders Common Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased Not known Drug-induced liver injury (DILI)* *see Description of selected adverse reactions Description of selected adverse reactions ALT increased/AST increased/DILI Serious cases with elevations of ALT and/or AST (> 10 x ULN) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP) were reported post-marketing.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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. 2) and this information cannot be reliably extrapolated. 2). Drug-induced liver injury (DILI) Elevations in serum alanine aminotransferase (ALT) levels and serum aspartate aminotransferase (AST) at least 3 times the upper limit of normal (ULN) were observed in women treated with fezolinetant, including serious cases with increased total bilirubin and symptoms suggesting liver injury.

Elevated liver function tests (LFTs) and symptoms suggestive of liver injury were generally reversible on discontinuation of therapy. LFTs must be performed prior to treatment initiation with fezolinetant. , ≥ 2 x ULN). LFTs must be performed monthly during the first three months of treatment, then based on clinical judgement.

LFTs must also be performed when symptoms suggestive of liver injury occur. Treatment should be discontinued in the following situations: − Transaminase elevations are ≥ 3 x ULN with: total bilirubin > 2 x ULN OR symptoms of liver injury.

− Transaminase elevations > 5 x ULN. 4 Monitoring of liver function should be maintained until they have normalised. Patients should be informed about the signs and symptoms of liver injury and should be advised to contact their doctor immediately once these occur.

, 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.

1. 5). 6).