VEOZA Film-coated tablet Ref.[107086] Active ingredients: Fezolinetant

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.

Hepatic impairment

No dose modification is recommended for individuals with Child-Pugh Class A (mild) chronic hepatic impairment (see section 5.2).

Veoza is not recommended for use in individuals with Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment. Fezolinetant has not been studied in individuals with Child-Pugh Class C (severe) chronic hepatic impairment (see section 5.2).

Renal impairment

No dose modification is recommended for individuals with mild (eGFR 60 to less than 90 ml/min/1.73 m²) or moderate (eGFR 30 to less than 60 ml/min/1.73 m²) renal impairment (see section 5.2).

Veoza is not recommended for use in individuals with severe (eGFR less than 30 ml/min/1.73 m²) renal impairment. Fezolinetant has not been studied in individuals with end-stage renal disease (eGFR less than 15 ml/min/1.73 m²) and is not recommended for use in this population (see section 5.2).

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.

Doses of fezolinetant up to 900 mg have been tested in clinical studies in healthy women. At 900 mg, headache, nausea, and paraesthesia were observed.

In the case of overdose, the individual should be closely monitored, and supportive treatment should be considered based on signs and symptoms.

3 years.

This medicinal product does not require any special storage conditions.

PA/Aluminium/PVC/Aluminium unit dose blisters in cartons.

Pack sizes: 28 × 1, 30 × 1, and 100 × 1 film-coated tablets.

Not all pack sizes may be marketed.

This medicinal product may pose a risk to the aquatic environment (see section 5.3).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.