Veozah™
Drug - Veozah™ (fezolinetant) [Astellas Pharma US, Inc.]
January 2025
Therapeutic area -
Initial approval criteria
- Patient is at least 18 years of age; AND
- Patient has a diagnosis of menopause with moderate to severe vasomotor symptoms; AND
- Patient does not have cirrhosis; AND
- Patient does not have severe renal impairment or end-stage renal disease; AND
- Patient will avoid concomitant therapy with weak, moderate, or strong CYP1A2 inhibitors (e.g., fluvoxamine, mexiletine, cimetidine); AND
- Prescriber attests that baseline liver function tests have been conducted and total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels are not elevated ≥ 2 times the upper limit of normal (ULN); AND
- Initial approval is for 3 months
Renewal criteria
- Patient must continue to meet the above criteria; AND
- Patient must have symptom improvement; AND
- Patient has not experienced any treatment-restricting adverse effects (e.g., ALT or AST > 3 times the ULN).
- Renewal approval is for 12 months
Quantity limits
Questions?
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