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
- Contraindication, intolerance, or insufficient response to one non-neurokinin pathway 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
Monitoring & Laboratory Requirements
- Perform baseline liver function testing before initiating fezolinetant (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 fezolinetant (and if any signs or symptoms of liver injury occur)
- Periodically reassess and discuss the need for continued treatment with patients, given the finite duration of VMS
- Consider periodic assessment of liver function during extended treatment
Discontinuation Criteria
- Discontinue fezolinetant if transaminase elevations are greater than 5 times upper limit of normal
- Discontinue fezolinetant if transaminase elevations are greater than 3 times upper limit of normal and the total bilirubin greater than 2 times upper limit of normal
Document 560: Menopausal Therapies in VA Table
Criteria for Systemic Hormonal Menopausal Medications
- Bazedoxifene/Conjugated Estrogens (DUAVEE): Alternative to progestin for patients with a uterus.
- Systemic Estrogen Preparations: Effective in treating vasomotor symptoms. Use the lowest effective dose of estrogen. Choice of product should consider patient symptoms, risk-benefit profile, and patient preference. Transdermal estrogen may have lower risk of thrombosis.
- Progestins (when used with systemic estrogen): 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
- Estradiol Ring (ESTRING): PA-F; subject to PBM Criteria for Use; classified as low dose vaginal estrogen.
- Ospemifene (OSPHENA): Oral option indicated for vaginal dryness and dyspareunia.
Criteria for Systemic Nonhormonal Medications
- Fezolinetant (VEOZAH): Subject to PBM Criteria for Use.
- Elinzanetant (LYNKUET): Pending PBM review.
- Testosterone Topical Gel: Indicated off-label for HSDD; use 1% testosterone gel tubes 50 mg (should last ~5–10 days); subject to PBM Clinical Guidance.
- Gabapentin: Useful for nocturnal symptoms.