ELAGOLIX TAB
Clinical Criteria Summary
Exclusion Criteria
- Pregnancy
- Known osteoporosis
- Severe hepatic impairment (Child-Pugh C)
- Concomitant use of organic anion transporting polypeptide (OATP)1B1 (e.g., gemfibrozil, cyclosporine)
- Known hypersensitivity
- Concomitant use of hormonal contraceptives
Inclusion Criteria
- Prescribed by or in consultation with a VA/VA Community Care Gynecology or Women’s Health Provider
- Diagnosis of endometriosis (clinical or surgical) in a premenopausal patient
- Contraindication, intolerance, or inadequate response to one alternative treatment (e.g., NSAID, estrogen-containing or progestin-only hormonal contraceptive)
- Assessed for history of suicidal ideation, depression, and mood disorders prior to starting treatment
- Assessed for risk of bone density loss
- Planned duration of treatment not to exceed a maximum of 6 months for high dose (200 mg twice daily) or 24 months for low dose (150 mg once daily) elagolix due to risk for bone loss
Additional Inclusion Criteria
- For patients who can become pregnant: Exclude pregnancy prior to receiving elagolix or start within 7 days of menses onset
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective nonhormonal contraception during treatment and for 28 days after stopping treatment
Safety Monitoring & Risk Assessment
- Monitor for mood changes and depressive symptoms after starting treatment due to association with mood disorders, depression, and suicidal ideation
- Consider bone mineral density (BMD) assessment in patients with history of low trauma fracture or risk factors for low bone density