FEZOLINETANT TAB

Clinical Criteria Summary

Moderate to severe vasomotor symptoms (VMS) associated with menopause
Contraindication or intolerance to menopausal hormone therapy (MHT) or patient preference to avoid MHT
Contraindication, intolerance, or insufficient response to one nonhormonal treatment for VMS

Known cirrhosis
Severe renal impairment (estimated glomerular filtration rate [eGFR] less than 30 ml/min/1.73m2)
Concomitant use of CYP1A2 inhibitors (e.g., cimetidine, mexiletine, fluvoxamine)
Baseline AST, ALT, or total bilirubin ≥ 2 times the upper limit of normal

Perform baseline liver function testing before initiating (ALT, AST, ALP, total and direct bilirubin)
Perform follow-up liver function testing monthly for the first 3 months, then at 6 and 9 months after initiating
Perform follow-up testing if any signs or symptoms of liver injury occur
Consider periodic assessment of liver function during extended treatment

Discontinue if transaminase elevations are greater than 5 times upper limit of normal
Discontinue if transaminase elevations are greater than 3 times upper limit of normal and total bilirubin greater than 2 times upper limit of normal

Periodically reassess and discuss the need for continued treatment given the finite duration of VMS
Advise patients on signs and symptoms of hepatotoxicity and when to seek medical attention

Dosing Criteria: 0.45 mg conjugated equine estrogens/20 mg bazedoxifene daily
Clinical Use Criteria: Bazedoxifene is an alternative to progestin for patients with a uterus
Systemic Estrogen Formulary Requirements:
Prescribe the lowest effective dose of estrogen
Product selection should consider patient symptoms, risk-benefit profile, and patient preference
A progestin (or bazedoxifene alternative) must be prescribed for all patients with an intact uterus receiving systemic estrogen to reduce endometrial hyperplasia and cancer risk