Recommended Age for Veozahh (Fezolinetant)
Veozahh (fezolinetant) is recommended for adults only and is not approved for use in children or adolescents of any age.
FDA Approval and Indication
Fezolinetant (Veozahh) received its first FDA approval in May 2023 as a non-hormonal treatment for moderate to severe vasomotor symptoms (hot flashes) associated with menopause 1. As a neurokinin 3 receptor (NK3R) antagonist, it works by modulating the activity of neurons associated with thermoregulation in the central nervous system.
Age-Specific Recommendations
The clinical trials that led to Veozahh's approval specifically enrolled women aged 40-65 years who were experiencing menopausal symptoms 2, 3. The SKYLIGHT 1 and SKYLIGHT 2 phase 3 randomized controlled trials that established the efficacy and safety of fezolinetant included only adult women in this age range 2, 3.
Efficacy Data
In clinical trials, fezolinetant demonstrated significant reductions in both:
- Frequency of vasomotor symptoms (hot flashes)
- Severity of vasomotor symptoms
These improvements were observed as early as 1 week after starting treatment and were maintained throughout the 52-week study period 2, 3.
Safety Considerations
The safety profile of Veozahh has only been established in adult women. Common treatment-related adverse events included:
- Hepatic events (22.7%)
- Visual disturbances (27.3%) 2
There is no safety or efficacy data for the use of Veozahh in pediatric populations, and the drug has not been studied in children or adolescents.
Clinical Application
Veozahh represents a non-hormonal alternative for treating menopausal symptoms in women who:
- Cannot take hormone therapy
- Do not wish to take hormonal treatments
- Have contraindications to estrogen therapy 4
Important Distinctions from Other Medications
Unlike some medications that may have pediatric dosing recommendations based on weight (such as those mentioned in other guidelines for tuberculosis treatment 5), Veozahh has no established pediatric dosing or indication. This contrasts with medications like ethambutol, which can be used in children weighing more than 40 kg with adult dosing 5.
Conclusion
Veozahh is exclusively indicated for adult women experiencing moderate to severe vasomotor symptoms associated with menopause, typically occurring in women aged 40-65 years. There is no approved use for this medication in pediatric populations of any age.