Indications for ORIAHNN:
Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Limitations of Use:
Limit use to 24 months due to the risk of continued bone loss, which may not be reversible.
Exclude pregnancy prior to starting or begin within 7 days from onset of menses. Take at same time each day. AM: 1 cap (300mg/1mg/0.5mg) daily. PM: 1 cap (300mg) daily.
High risk of arterial, venous thrombotic, or thromboembolic disorder (eg, smokers or migraineurs over 35 years of age, history of DVT or PE, vascular disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, headaches with focal neurologic symptoms). Pregnancy. Osteoporosis. Hepatic impairment or disease. Breast cancer or other hormonally-sensitive malignancies. Undiagnosed abnormal uterine bleeding. Concomitant OATP1B1 inhibitors that are known or suspected to potentiate elagolix.
Thromboembolic disorders. Vascular events.
Increased risk of thrombotic or thromboembolic disorders. Discontinue if thrombotic, cardiovascular or cerebrovascular event, unexplained visual changes, or jaundice occurs and at least 4–6 weeks prior to surgery associated with increased risk of thromboembolism or during periods of immobilization. Risk of decrease in bone mineral density (BMD). Assess BMD at baseline and periodically thereafter. Consider treatment benefits/risks in those with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss; supplementation with calcium and Vit.D may be beneficial. Perform breast exams and regular mammography. Discontinue if a hormonally-sensitive malignancy develops. Evaluate if new onset or worsening depression, anxiety, other mood changes occur. Monitor BP; discontinue if significant rise occurs. Gallbladder disease. History of cholestatic jaundice associated with prior estrogen use or with pregnancy. Monitor lipid levels; consider discontinuing if hypertriglyceridemia or hypercholesterolemia worsens. Diabetes. Prediabetes. Hypothyroidism. Hypoadrenalism. Reduced ability to recognize pregnancy. Perform pregnancy testing if suspected; discontinue if confirmed. Advise women to use non-hormonal contraception during and for 1 week after discontinuation. Nursing mothers.
GnRH antagonist + estrogen + progestin.
See Contraindications. May potentiate P-gp substrates (eg, digoxin; monitor), CYP2C19 substrates (eg, omeprazole; limit doses to ≤40mg daily). May antagonize CYP3A substrates. Antagonizes oral midazolam, rosuvastatin: consider increasing their doses. May be antagonized by strong CYP3A inducers. May be potentiated by strong CYP3A inhibitors, rifampin: not recommended. May affect levels of thyroid-binding globulin, corticosteroid-binding globulin, coagulation factors, sex hormone binding globulin, lipids, glucose.
Hot flushes, headache, fatigue, metrorrhagia; bone loss, elevated hepatic transaminase, elevated lipids, hypertension, depression-related adverse reactions, mood changes, alopecia.
Caps—56 (14 weekly blister packs x 4)