INDICATION1
ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.
IMPORTANT SAFETY INFORMATION1
THROMBOEMBOLIC AND VASCULAR EVENTS
Estrogen and progestin combinations, including ORIAHNN, increase the risk of thrombotic or thromboembolic disorders, including pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events.
ORIAHNN is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke and women with uncontrolled hypertension.
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Vascular Events
Bone Loss
Hormonally Sensitive Malignancies
Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders
Hepatic Impairment and Transaminase Elevations
Elevated Blood Pressure
Gallbladder Disease or History of Cholestatic Jaundice
Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy
Effects on Carbohydrate and Lipid Metabolism
Alopecia
Effect on Other Laboratory Results
RISK OF ALLERGIC REACTIONS DUE TO THE INACTIVE INGREDIENT (FD&C YELLOW NO. 5)
ADVERSE REACTIONS
These are not all of the possible side effects of ORIAHNN.
Safety and effectiveness of ORIAHNN in pediatric patients have not been established.
US-ORIA-210460
Please see Full Prescribing Information.
References: 1. ORIAHNN [package insert]. North Chicago, IL: AbbVie Inc. 2. Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382(4)(suppl):328-340. doi:10.1056.NEJMoa1904351. 3. Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135(6):1313-1326. doi:10.1097/AOG.0000000000003869. 4. Data on file. ABVRRTI71860. 5. Dasharathy SS, Mumford SL, Pollack AZ, et al. Menstrual bleeding patterns among regularly menstruating women. Am J Epidemiol. 2012;175(6):536-545. doi:10.1093/aje/kwr356. 6. Fraser IS, Critchley HO, Broder M, Munro MG. The FIGO recommendations on terminologies and definitions for normal and abnormal uterine bleeding. Semin Reprod Med. 2011;29(5):383-390. doi:10.1055/s-0031-1287662. 7. Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021;224(1):72.e1-72.e50. doi:10.1016/j.ajog.2020.07.032. 8. Data on file. ABVRRTI71538. 9. Data on file. ABVRRTI71503. 10. Munro MG, Critchley HOD, Fraser IS; FIGO Menstrual Disorders Committee. The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions. Int J Gynaecol Obstet. 2018;143(3)393-408. doi:10.1002/ijgo.12666. 11. Sheth SS, Hajari AR, Lulla CP, Kshirsagar D. Sonographic evaluation of uterine volume and its clinical importance. J Obstet Gynaecol Res. 2017;43(1):185-189. doi:10.1111/jog.13189. 12. Harb TS, Adam RA. Predicting uterine weight before hysterectomy: ultrasound measurements versus clinical assessment. Am J Obstet Gynecol. 2005;193(6):2122-2125. doi:10.1016/j.ajog.2005.07.014. 13. Jimenez K, Kulnigg-Dabsch S, Gasche C. Management of iron deficiency anemia. Gastroenterol Hepatol. 2015;11(4):241-250. 14. Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002;99(2):290-300. doi:10.1016/s0029-7844(01)01702-1. 15. Coyne KS, Margolis MK, Bradley LD, Guido R, Maxwell GL, Spies JB. Further validation of the uterine fibroid symptom and quality-of-life questionnaire. Value Health. 2012:15(1):135-42. doi:10.1016/j.jval.2011.07.007. 16. Al-Hendy A, Soliman AM, Wang H, Coyne K, Carr BR. Elagolix improves quality of life among uterine fibroids patients with heavy menstrual bleeding in phase 3 trials. Poster presented at: Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists; May 3-6, 2019; Nashville, TN. 17. Data on file. ABVRRTI70605. 18. Data on file. ABVRRTI69765. 19. Data on file. ABVRRTI70883. 20. Data on file. ABVRRTI71826. 21. Data on file. ABVRRTI71523. 22. Gillispie V. Up to 12 months of efficacy and safety of elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroids. Presented at: American Association of Gynecologic Laparoscopists 48th Global Congress on MIGS; November 9-13, 2019; Vancouver, British Columbia, Canada.