VEOZA™ (fezolinetant) 45 mg film-coated tablets
▼ 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.
Pharmacotherapeutic group: Other gynaecologicals, ATC code: G02CX06.
Therapeutic indications: VEOZA is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause (see Section 5.1 in the Summary of Product Characteristics (SmPC)).
*Posology: Recommended dose is 45 mg once daily.
Contraindications: Hypersensitivity to the active substance or to any of the excipients; concomitant use of moderate or strong CYP1A2 inhibitors; known or suspected pregnancy.
*Special warnings and precautions for use: Diagnosis must include medical (including family) history. During treatment, periodic check-ups must be carried out according to standard clinical practice. Is not recommended for use in individuals with Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment, nor in individuals with severe renal impairment. Monitoring of liver function in women with known or suspected hepatic disorder is advised. VEOZA is not recommended in women undergoing oncologic treatment for breast cancer or other oestrogen-dependent malignancies, nor in women using hormone replacement therapy with oestrogens (local vaginal preparations excluded). Has not been studied in women over 65 years of age, nor in women with a history of seizures or other convulsive disorders. Animal studies have shown reproductive toxicity.
*Undesirable effects: The listed adverse drug reactions are insomnia, diarrhoea, abdominal pain, and increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST), all with a frequency of less than 10%.
Marketing authorisation holder: Astellas Pharma Europe B.V., The Netherlands.
Norway: Dispensing group: C. Reimbursement: No. Pack size and price (pr 16.01.2024): 45 mg: 30 tabl. (blister) 836.90 kr. Local representative: Astellas Pharma, Tel: +47 66 76 46 00. For more information see www.felleskatalogen.no.
Based on authorised SmPC dated 07 December 2023.
*The section has been rewritten and/or abbreviated compared to the authorised SmPC. The SmPC can be ordered free of charge from the local representative.
VEOZA™ (fezolinetant) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause*1
Use this form to discuss with your patients the current impact and severity of vasomotor symtoms in their lives
VEOZA is a neurokinin 3 (NK3) receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, also known as hot flushes and night sweats1-3
VEOZA is not a hormone. It is a VMS treatment that blocks NKB, a known trigger of VMS associated with menopause2,4,5
It is a selective NK3 receptor antagonist that blocks NKB binding on the KNDy neuron to modulate neuronal activity in the thermoregulatory centre. This action helps to reduce the number and intensity of hot flushes and night sweats2
KNDy=kisspeptin/neurokinin B/dynorphin; NK3=neurokinin 3; NKB=neurokinin B; VMS=vasomotor symptoms
VEOZA demonstrated statistically significant reductions from baseline in the frequency and severity of moderate to severe VMS per 24 hours in postmenopausal women compared to placebo, at weeks 4 and 122*
The efficacy of VEOZA was evaluated in two 12-week, randomised, placebo-controlled, double-blind phase 3 studies, followed by a 40-week non-placebo controlled treatment extension period2
The efficacy of VEOZA was evaluated in two identical 12-week, randomised, placebo-controlled, double-blind Phase 3 studies (SKYLIGHT 1 & SKYLIGHT 2), followed by a 40-week non-placebo controlled extension treatment period.2 The studies consisted of postmenopausal women with a minimum average of 7 moderate to severe VMS per day2
*Improvement compared to placebo, does not indicate statistical significance.
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 be broken, crushed or chewed6
Across the phase 3 studies, the most common adverse reactions (≥3%) with VEOZA 45 mg were diarrhoea (3.2%) and insomnia (3.0%). The most frequent adverse reactions leading to dose discontinuation with VEOZA were alanine aminotransferase (ALT) increased (0.3%) and insomnia (0.2%)7
The safety of VEOZA was evaluated in phase 3 clinical studies with 2 203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice5
Legend: Common (≥ 1/100 to < 1/10); Not known (cannot be estimated from the available data).
* SmPC see section 4.8
Practice resources, such as mechanism of action video, quick product overview leaflet, VMS symptom survey tool, are avilable to help you evaluate VEOZA
*See section 5.1 in SmPC
REFERENCES: 1. VEOZA SmPC §4.1 02.2025. 2. VEOZA SmPC §5.1 02.2025. 3. Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinicians’ Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society, 2019:43-55. 4. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin Investig Drugs. 2021;30(7):681-94. 5. Jayasena CN, Comninos AN, Stefanopoulou E, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015; 5:8466. 6. VEOZA SmPC §4.2 02.2025. 7. VEOZA SmPC §4.8 02.2025.
VEOZA™ (fezolinetant) 45 mg filmdrasjerte tabletter
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Farmakoterapeutisk gruppe: Middel mot vasomotoriske symptomer ved menopause (G02CX06).
Indikasjoner: Behandling av moderate til alvorlige vasomotoriske symptomer (VMS) assosiert med menopause (se preparatomtalen (SPC) pkt. 5.1).
*Dosering: 45 mg 1 gang daglig.
Kontraindikasjoner: Overfølsomhet for innholdsstoffene. Samtidig bruk av moderate eller sterke CYP1A2‑hemmere. Kjent eller mistenkt graviditet.
*Forsiktighetsregler: Diagnosen må inkludere medisinsk (inkl. familie) historie. Under behandlingen skal det utføres periodiske kontroller. Anbefales ikke til personer med Child-Pugh klasse B (moderat) eller C (alvorlig) kronisk leversvikt, eller til personer med alvorlig nedsatt nyrefunksjon. Overvåkning av leverfunksjon hos kvinner med kjent eller mistenkt leversykdom anbefales. Ikke anbefalt ved onkologisk behandling mot brystkreft eller andre østrogenavhengige maligniteter, eller til kvinner som bruker hormonerstatningsterapi med østrogener (lokale vaginale preparater unntatt). Har ikke blitt studert hos kvinner over 65 år eller hos kvinner med en historie med anfall eller andre krampeforstyrrelser. Dyrestudier har vist reproduksjonstoksisitet.
*Bivirkninger: Insomni, diaré, abdominalsmerter, økt ALAT og økt ASAT, alle med frekvens <10%.
MT-innehaver: Astellas Pharma Europe B.V., Nederland.
Reseptgruppe: C Refusjon: Nei. Pakningsstørrelse og pris (pr. DD.MM.YYYY): 45 mg: 30 tabletter (blister) XXXX kr. Lokal representant: Astellas Pharma, Tel: +47 66 76 46 00. For mer informasjon se www.felleskatalogen.no