Posology : מינונים

4.2     Posology and method of administration

Posology
Liver function tests (transaminases and bilirubin) should be determined before initiating therapy with fezolinetant. Monitoring should occur during the first 3 months of treatment. Further checks should be carried out at the discretion of the treating doctor depending on the individual risk constellation and if symptoms occur that could indicate liver damage (such as nausea, vomiting or jaundice). If there is evidence of liver dysfunction, treatment with fezolinetant should be discontinued or temporarily interrupted at the discretion of the treating physician after alternative causes for the transaminase elevation have been clarified. Due to the risk of transaminase elevations, a maximum dose of 45 mg per day must not be exceeded.

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
In a population pharmacokinetic analysis, baseline liver function values were found to be a relevant risk factor for an increase in transaminases. VEOZA must therefore not be used in patients with pre- existing moderate or severe liver insufficiency. Its use is not recommended in patients with mildly impaired liver function. If such patients are treated with fezolinetant, liver function tests should be monitored closely.

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.