ELAGOLIX/ ESTRADIOL/ NORETHRINDRONE CAP,ORAL
Clinical Criteria Summary
Document 579
Indication & Patient Population
- Heavy Menstrual Bleeding Associated with Uterine Leiomyomas (Fibroids)
- Premenopausal patient
Exclusion Criteria
- High risk or history of arterial, venous thrombotic, or thromboembolic disorder
- Pregnancy
- Known osteoporosis
- Uncontrolled hypertension
- Current or history of breast cancer or other hormonally sensitive malignancies
- Known hepatic impairment or disease
- Undiagnosed abnormal uterine bleeding
- Concomitant use of hormonal contraceptives
- Concomitant use of organic anion transporting polypeptide (OATP) 1B1 (e.g., gemfibrozil, cyclosporine)
- Any additional contraindication to receiving estrogen and/or progestin
- Known hypersensitivity to elagolix, estradiol, or norethindrone
Inclusion Criteria
- Prescribed by or in consultation with a VA/VA Community Care Gynecology or Women’s Health Provider
- Confirmed diagnosis of uterine leiomyoma and heavy menstrual bleeding
- Contraindication, intolerance, or inadequate response to one alternative treatment (e.g., estrogen-progestin hormonal contraceptives, progestin-only contraceptives, tranexamic acid)
Monitoring, Duration, & Safety Requirements
- 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 24 months (due to risk for bone loss)
- Monitor for mood changes and depressive symptoms after starting treatment
- Baseline DXA (dual-energy X-ray absorptiometry) and periodic follow-up during treatment; consider risks and benefits in patients with history of low trauma fracture or risk factors for low bone density
Pregnancy Prevention & Counseling
- Exclude pregnancy prior to receiving EEN or start within 7 days of menses onset
- Counseling provided on potential risks vs. benefits of treatment
- Use of effective nonhormonal contraception during treatment and for 28 days after stopping treatment
Document 588
Indication & Patient Population
- Management of heavy menstrual bleeding (HMB) associated with uterine leiomyomas (fibroids) in premenopausal women
- Applicable to premenopausal women 18 to 51 years old with ultrasound-confirmed diagnosis of uterine fibroids and HMB defined as > 80 ml menstrual blood loss per cycle for ≥ 2 cycles
Dosing & Administration
- One oral capsule taken twice daily, packaged in weekly blister packs
- Morning dose: elagolix 300 mg, estradiol 1 mg, norethindrone 0.5 mg
- Evening dose: elagolix 300 mg
Contraindications
- High risk of arterial, venous thrombotic, or thromboembolic disorders
- Pregnancy
- Known osteoporosis
- Current or history of breast cancer or other hormonally sensitive malignancies
- Known hepatic impairment or disease
- Undiagnosed abnormal uterine bleeding
- Known anaphylactic reaction to EEN
- Concomitant use of organic anion transporting polypeptide (OATP)1B1 inhibitors (e.g., cyclosporine, gemfibrozil)
Warnings & Precautions
- Boxed warning: Risk of thromboembolic disorders and vascular events
- Bone loss
- Suicidal ideation and exacerbation of mood disorders
- Transaminase elevations
- Elevated blood pressure
- Change in menstrual bleeding pattern and reduced ability to recognize pregnancy
- Alopecia
- Allergy to FD&C Yellow No. 5
- Additional standard warnings for estrogen and progestin
Treatment Duration & Limitations
- Maximum treatment duration of 24 months due to concerns of bone loss
- Add-back therapy (estrogen plus progestin) combined with elagolix to lessen bone loss and improve overall tolerability