VEOZA

/ Astellas

The recommended dose is 45 mg once daily.
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.
See prescribing information for full details.

indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause

* Hypersensitivity to the active substance or to any of the excipients
* Concomitant use of moderate or strong CYP1A2 inhibitors.
* Known or suspected pregnancy.
* Moderate or severe hepatic impairment (Child Pugh B or C).

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. 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.
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
Concomitant use of fezolinetant and hormone replacement therapy with oestrogens has not been studied, and therefore concomitant use is not recommended. (local vaginal preparations excluded).
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 fezolinetant should be based on a benefit-risk consideration for the individual
See prescribing information for full details.

Common: Insomnia, diarrhoea, abdominal pain, Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased
See prescribing information for full details.

Effect of other medicinal products on fezolinetant
CYP1A2 inhibitors
Fezolinetant is primarily metabolised by CYP1A2 and to a lesser extent by CYP2C9 and CYP2C19. Concomitant use of fezolinetant with medicinal products that are moderate or strong inhibitors of CYP1A2 (e.g., ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine) increase the plasma Cmax and AUC of fezolinetant. Concomitant use of moderate or strong CYP1A2 inhibitors with this medical product is contraindicated.
See prescribing information for full details.

Pregnancy
Fezolinetant is contraindicated during pregnancy. If pregnancy occurs during use with fezolinetant, treatment should be withdrawn immediately. There are no or limited data from the use of fezolinetant in pregnant women.
Lactation
Fezolinetant is not indicated during lactation. It is unknown whether fezolinetant and its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from fezolinetant therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

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.