FEZOLINETANT TAB
Clinical Criteria Summary
Document 484: Fezolinetant VEOZAH Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Laboratory Monitoring Requirements
- 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
Discontinuation Criteria
- 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
Patient Counseling & Reassessment
- 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
Document 560: Menopausal Therapies in VA Table
Criteria for Systemic Hormonal Menopausal Medications
- Bazedoxifene/Estrogens: Bazedoxifene is an alternative to progestin for patients with a uterus.
- General Systemic Estrogen Therapy:
- All systemic estrogen preparations are effective in treating vasomotor symptoms.
- Transdermal estrogen may have lower risk of thrombosis.
- The lowest effective dose of estrogen should be used.
- Choice of product should consider patient symptoms, risk-benefit profile, and patient preference.
- A progestin should be prescribed to all patients with an intact uterus receiving systemic estrogen therapy to reduce the risk of endometrial hyperplasia and cancer.
Criteria for Genitourinary Symptoms of Menopause (GSM) Medications
- Prasterone (DHEA): PA-F (Prior Authorization, Facility Level) applies; PBM Criteria for Use available. Classified as low dose vaginal estrogen.
- Estradiol vaginal ring (Estring): Not to be confused with FEMRING.
Criteria for Systemic Nonhormonal Medications
- Ospemifene: Oral option indicated for vaginal dryness and dyspareunia.
- Fezolinetant: PBM Criteria for Use available.
- Citalopram, Escitalopram, Paroxetine, Desvenlafaxine, Venlafaxine, Gabapentin, Oxybutynin: PBM Criteria for Use available; all marked as off-label use.