ABBREVIATED SUMMARY OF PRODUCT CHARACTERISTICS
 

For full prescribing information refer to the Summary of Product Characteristics (SPC).

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
NAME OF THE MEDICINAL PRODUCT: Veoza 45 mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each film-coated tablet contains 45 mg of fezolinetant. For the full list of excipients, see section 6.1 of the SPC.
PHARMACEUTICAL FORM: Film-coated tablet (tablet). Round, light red tablets (approximately 7 mm diameter × 3 mm thickness), debossed with the company logo and ‘645’ on the same side.
CLINICAL PARTICULARS: Therapeutic indications: Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause (see section 5.1 of the SPC). Posology and method of administration: 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 of the SPC). 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 of the SPC). 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 of the SPC). 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 of the SPC). 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. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC. Concomitant use of moderate or strong CYP1A2 inhibitors (see section 4.5 of the SPC). Known or suspected pregnancy (see section 4.6 of the SPC). Special warnings and precautions for use: 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. Women with active liver disease or Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment have not been included in the clinical efficacy and safety studies with fezolinetant (see section 4.2 of the SPC) and this information cannot be reliably extrapolated. The pharmacokinetics of fezolinetant has been studied in women with Child-Pugh Class A (mild) and B (moderate) chronic hepatic impairment (see section 5.2 of the SPC). 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. Treatment should not be started if ALT or AST is ≥ 2 x ULN or if total bilirubin is elevated (e.g., ≥ 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. 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. 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 (local vaginal preparations excluded): Concomitant use of fezolinetant and hormone replacement therapy with oestrogens has not been studied, and therefore concomitant use is not recommended. 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 Veoza should be based on a benefit-risk consideration for the individual. Interactions: 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 C_max and AUC of fezolinetant. Concomitant use of moderate or strong CYP1A2 inhibitors with Veoza is contraindicated (see section 4.3 of the SPC). Co-administration with fluvoxamine, a strong CYP1A2 inhibitor, resulted in an overall 1.8-fold increase in fezolinetant C_max and 9.4-fold increase in AUC; no change in t_max was observed. Given the large effect of a strong CYP1A2 inhibitor and supportive modelling, the increase in fezolinetant concentrations is expected to be of clinical concern also following concomitant use with moderate CYP1A2 inhibitors (see section 4.3 of the SPC). The increase in fezolinetant exposure was however not predicted to be clinically relevant following concomitant use with weak CYP1A2 inhibitors. CYP1A2 inducers: In vivo data: Smoking (moderate inducer of CYP1A2) decreased fezolinetant C_max to a geometric LS mean ratio of 71.74%, while AUC decreased to a geometric LS mean ratio of 48.29%. The efficacy data did not point to relevant differences between smokers and non-smokers. No dose modification is recommended for smokers. Transporters: In vitro data: Fezolinetant is not a substrate of P-glycoprotein (P-gp). Major metabolite ES259564 is a substrate of P-gp. Effect of fezolinetant on other medicinal products: Cytochrome P450 (CYP) enzymes: In vitro data: Fezolinetant and ES259564 are not inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Fezolinetant and ES259564 are not inducers of CYP1A2, CYP2B6, and CYP3A4. Transporters: In vitro data: Fezolinetant and ES259564 are not inhibitors of P-gp, BCRP, OATP1B1, OATP1B3, OCT2, MATE1, and MATE2-K (IC50 > 70 µmol/l). Fezolinetant inhibited OAT1 and OAT3 with IC50 values of 18.9 µmol/l (30 × C_max,u) and 27.5 µmol/l (44 × C_max,u), respectively. ES259564 does not inhibit OAT1 and OAT3 (IC50 > 70 µmol/l). Undesirable effects: Summary of the safety profile: The most frequent adverse reactions with fezolinetant 45 mg were diarrhoea (3.2%) and insomnia (3.0%). 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. The most serious adverse reaction was an event of endometrial adenocarcinoma (0.1%). The most frequent adverse reactions leading to dose discontinuation with fezolinetant 45 mg were alanine aminotransferase (ALT) increased (0.3%) and insomnia (0.2%). 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

*see Description of selected adverse reactions
Description of selected adverse reactions: ALT increased/AST increased/DILI: In clinical trials, elevations in ALT levels > 3 x ULN occurred in 2.1% of women receiving fezolinetant compared to 0.8% of women receiving placebo. Elevations in AST levels > 3 x ULN occurred in 1.0% of women receiving fezolinetant compared to 0.4% of women receiving placebo. 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. In some cases, elevated liver function tests were associated with signs and symptoms suggestive of liver injury such as fatigue, pruritus, jaundice, dark urine, pale faeces, nausea, vomiting, decreased appetite, and/or abdominal pain (see section 4.4 of the SPC). Overdose: 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.
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.
België/Belgique: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten / Agence fédérale des médicaments et des produits de santé; www.fagg.be / www.afmps.be; Afdeling Vigilantie / Division Vigilance: Website/Site internet: www.eenbijwerkingmelden.be / www.notifieruneffetindesirable.be; e-mail: adr@fagg-afmps.be

Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie or Astellas Pharma Co. Ltd. Tel: +353 1 467 1555, E-mail: irishdrugsafety@astellas.com.
Nederland: Nederlands Bijwerkingen Centrum Lareb; Website: www.lareb.nl
Luxembourg/Luxemburg : Centre Régional de Pharmacovigilance de Nancy ou Division de la pharmacie et des médicaments de la Direction de la santé ; Site internet : www.guichet.lu/pharmacovigilance

MARKETING AUTHORISATION HOLDER: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands

MARKETING AUTHORISATION NUMBERS: EU/1/23/1771/001-004

DATE OF REVISION OF THE TEXT: February 2025
Job Bag Number: MAT-IE-VEO-2025-00015

Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu.
Ireland: Astellas Pharma Co. Ltd., Tel.: +353 1 467 1555. SPC may be found at www.medicines.ie.

Delivery Status: subject to medical prescription.
Astellas Pharma B.V.,
NL: Sylviusweg 62, 2333BE Leiden, Netherlands
BE/LU: Medialaan 50, 1800 Vilvoorde, Belgium
IE: Legal classification: POM/S1A.