VEOZA™ FILM-COATED TABLETS 45 MG [SIN17196P]

Product Info

VEOZA™ FILM-COATED TABLETS 45 MG

[SIN17196P]

4.1 Therapeutic indications

VEOZA is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Concomitant use of moderate or strong CYP1A2 inhibitors (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).