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
The efficacy of VEOZA was evaluated in postmenopausal women with moderate to severe VMS in two 12-week, randomised, placebo-controlled, double-blind phase 3 studies, followed by a 40-week non-placebo controlled extension treatment period2
Coprimary endpoints: Mean change from baseline in moderate to severe VMS frequency and severity2
Clinically meaningful is defined as a reduction in ≥2 hot flushes per 24 h versus placebo2
VMS=vasomotor symptoms
The efficacy of VEOZA was evaluated in postmenopausal women with moderate to severe VMS in two 12-week, randomised, placebo-controlled, double-blind phase 3 studies, SKYLIGHT 1 and SKYLIGHT 2, followed by a 40-week non-placebo controlled extension treatment period1-3
Coprimary endpoints:
Mean change from baseline in moderate to severe VMS frequency and severity1-3
Participants in the study:1-3
*Baseline demographics also include women receiving fezolinetant 30 mg
Figure adapted from reference 2 and 3
REFERENCES: 1. VEOZA SmPC §5.1 12.2023. 2. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomises controlled study. Lancet. 2023;401(10382):1091-102. 3. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. 2023;108(8):1981-1997.
REFERENCES: 1. VEOZA SmPC §5.1 12.2023. 2. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomises controlled study. Lancet. 2023;401(10382):1091-102. 3. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. 2023;108(8):1981-1997.
REFERENCES: 1. VEOZA SmPC §5.1 12.2023. 2. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomises controlled study. Lancet. 2023;401(10382):1091-102. 3. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. 2023;108(8):1981-1997.
VEOZA provides statistically significant relief from the number and severity of daily hot flushes and night sweats compared with placebo2
FREQUENCY: Measured as a daily mean and analyzed as weekly average2-4
LS mean: Least squares mean estimated from a mixed model for repeated measures analysis of covariance2
Data cointain a pooled analysis of SKYLIGHT 1 and SKYLIGHT 22
†Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment2
Figure adapted from reference 2
VEOZA provided statistically significant reductions in the severity of VMS episodes at weeks 4 and 122
BLN=baseline; SE=standard error; VMS=vasomotor symptoms; WK=week
Data contain a pooled analysis of SKYLIGHT 1 and SKYLIGHT 22
†Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment2
Figure made by Astellas based on the references 2-4
Patients taking VEOZA experienced a reduction in VMS episodes at weeks 4 and 12 (coprimary endpoints), which was sustained through 52 weeks)3,4
Mean change in frequency of VMS from baseline to each week up to week 12 was a secondary endpoint and was not adjusted for multiplicity3,4
Mean change in the frequency of VMS from baseline to each visit in the extension period was an exploratory endpoint. Assessments after the 12-week placebo-controlled period were descriptive only3,4
Figure adapted from reference 3 and 4
The safety of VEOZA was evaluated in phase 3 clinical studies with 2 203 postmenopausal women receiving VEOZA2
Two identical phase 3 efficacy and safety studies that were randomised, placebo-controlled, double-blind for 12 weeks, followed by re-randomisation of women previously receiving placebo to VEOZA (women on VEOZA remained on VEOZA) for an additional 40 weeks of non-placebo controlled treatment2-4
One phase 3, 52-week, randomised, placebo-controlled, double-blind study evaluating safety5
SKYLIGHT 4 was a randomised, placebo-controlled, double-blind, 52-week phase 3 stafety study of postmenopausal women, aged ≥40 to ≤65 years, seeking treatment for VMS1
Primary endpoints:1
Figure adapted from reference 1
Study population1
*Baseline demographics include women receiving fezolinetant 30 mg
REFERENCE: 1. Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomized controlled trial. Obstet Gynecol. 2023;141(4):737-47.
REFERENCE: 1. Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomized controlled trial. Obstet Gynecol. 2023;141(4):737-47.
REFERENCE: 1. Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomized controlled trial. Obstet Gynecol. 2023;141(4):737-47.
*See section 5.1 in SmPC
REFERENCES: 1. VEOZA SmPC §4.1 02.2024. 2. VEOZA SmPC §5.1 02.2024. 3. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet 2023;401(10382):1091-102. 4. Johnson KA, Martin N, Nappi RE, et al. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023;108(8):1981-1997. 5. Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomized controlled trial. Obstet Gynecol. 2023;141(4):737-47. 6. VEOZA SmPC § 4.8 02.2024.