Fezolinetant tablets (Veozah) - selected U.S. label sections
- Product / population
- VEOZAH oral tablets for the labeled menopausal vasomotor-symptom indication.
- Renal measure
- eGFR in mL/min/1.73 m2
Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.
Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.
Renal restrictions
Mild impairment (eGFR 60 to below 90) and moderate impairment (30 to below 60) do not require adjustment. Severe impairment (15 to below 30) and end-stage disease (below 15) are contraindications.
Additional mandatory safety review
The boxed warning concerns hepatotoxicity. Obtain hepatic laboratory tests before initiation, monthly for the first 3 months, and at months 6 and 9. Cirrhosis and concomitant CYP1A2 inhibitors are also contraindications. A renal eligibility finding alone does not establish treatment eligibility.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cae9f798-24f9-4580-a4fc-e6c710cbda3c