ONE treatment that controls heavy menstrual bleeding due
to fibroids1

Study design: ORIAHNN was studied in two 6-month Phase 3 pivotal studies (ELARIS UF-1 AND UF-2) including premenopausal women aged 25-53 with heavy menstrual bleeding associated with uterine fibroids and in an additional 6-month extension study (UF-EXTEND), which did not include a placebo arm1-3

ORIAHNN controls heavy menstrual bleeding due to fibroids

Proportion of women achieving a clinically meaningful bleeding reduction at Final Month1†

ELARIS UF-2

ELARIS UF-1

ORIAHNN

77%

(n=189)

Placebo

11%

(n=94)

P<0.001

Final Month

The last 28 days before and including the last treatment visit date or the last dose date. This can occur anytime from Month 1 to 6 in the pivotal studies.1


Results were similar in ELARIS UF-1 [ORIAHNN (n=206): 69%; placebo (n=102): 9%, P<0.001].

ELARIS UF-1

Results were similar in ELARIS UF-1 [ORIAHNN (n=206): 69%; placebo (n=102): 9%, P<0.001].

What did it take to achieve a
clinically meaningful bleeding
reduction?

Measuring Cup Icon.

≥50% bleeding volume reduction from baseline to Final Month1†

AND

Measuring Cup Icon.

<80 mL bleeding volume at Final Month1†

=

responder

=  responder

Quick and continued menstrual bleeding reduction with ORIAHNN

Over 50% bleeding reduction at Month 1 and continued reduction seen at Months 3 and 64

Menstrual blood loss (MBL) reduction in ELARIS UF-24

Graph depicting reduction in menstrual bleeding after 6 months with ORIAHNN as compared to placebo. Graph depicting reduction in menstrual bleeding after 6 months with ORIAHNN as compared to placebo. Graph depicting reduction in menstrual bleeding after 6 months with ORIAHNN as compared to placebo.

Results were similar in ELARIS UF-1 [Month 1: ORIAHNN (n=187), 52% (124.3 mL) mean reduction, MBL=106 mL; placebo (n=95), 13% (33.1 mL) mean reduction, MBL=226 mL; Month 3: ORIAHNN (n=172), 82% (186.8 mL) mean reduction, MBL=44 mL; placebo (n=85), 4% (0.1 mL) mean reduction, MBL=263 mL; Month 6: ORIAHNN (n=132), 81% (188.5 mL) mean reduction, MBL=41 mL; placebo (n=71), 3% (8.8 mL) mean reduction, MBL=240 mL].

On average, normal menstrual bleeding in women without fibroids is 30-47 mL5,6

Regardless of her characteristics, ORIAHNN controlled her heavy menstrual bleeding

Proportion of women who met the primary endpoint in ELARIS UF-1 and UF-2 at Final Month1,7-12†

Subgroup analyses of the primary endpoint were explored to assess potential differences in treatment effect across subgroup levels and were not controlled for multiplicity.

Click on a subgroup to view results

Select a subgroup to view results

Disease severity subgroups

Baseline ranges and percentages for race and ethnicity depict the entire study population (N=790), while the subgroup analyses depict the ORIAHNN group alone.

72%

Overall pooled results for primary endpoint in ELARIS UF-1 and UF-2 (n=395)7

ORIAHNN delivered clinically significant# improvement in Hgb levels at Month 61,13

In women with anemia who took ORIAHNN

Proportion of women with baseline Hgb ≤10.5 g/dL who achieved a >2 g/dL increase at Month 6

ELARIS UF-2

ELARIS UF-1

ORIAHNN

50%

(n=48)

Placebo

21%

(n=24)

P=0.02

Month 6

Results were similar in ELARIS UF-1 [ORIAHNN (n=52): 62%, placebo (n=31): 16%, P<0.001].

ELARIS UF-1

Results were similar in ELARIS UF-1 [ORIAHNN (n=52): 62%, placebo (n=31): 16%, P<0.001].

Over 90% of women with baseline Hgb ≤10.5 g/dL took supplemental iron.

During the ELARIS UF-1 and UF-2 trials 2 women (0.5%) had heavy menstrual bleeding and required blood transfusion due to anemia (a serious adverse event).

The baseline Hgb in the anemic ORIAHNN-treated women evaluated in this endpoint was ≤10.5 g/dL1

Amenorrhea with ORIAHNN—defined as zero bleeding or spotting2

Proportion of women who experienced Amenorrhea at Final Month2

Percentage of women with Amenorrhea was a non-ranked secondary endpoint. These results were not controlled for multiplicity.

ELARIS UF-2

ELARIS UF-1

ORIAHNN

53%

(n=172)

Placebo

5%

(n=85)

Final Month

The last 28 days before and including the last treatment visit date or the last dose date. This can occur anytime from Month 1 to 6 in the pivotal studies.1

Results were similar in ELARIS UF-1 [ORIAHNN (n=183): 48%, placebo (n=91): 4%].

ELARIS UF-1

Results were similar in ELARIS UF-1 [ORIAHNN (n=183): 48%, placebo (n=91): 4%].

In ORIAHNN clinical trials, Amenorrhea was defined as having zero bleeding or spotting during the Final Month,† which was a 28-day interval1,2

Quality-of-life and symptom severity results

Health-related quality-of-life scores in ELARIS UF-22,14-17

Total scores for HRQoL range from 0 to 100, with higher scores indicating a better HRQoL

  •  
    ORIAHNN
  •  
    Placebo

86: HRQoL score for normal control group (women without fibroids)14,15

Symptom severity scores in ELARIS UF-22,14-17

Scores for symptom severity range from 0 to 100, with higher scores indicating increased severity

  •  
    ORIAHNN
  •  
    Placebo

23: Symptom severity score for normal control group (women without fibroids)14,15

The UFS-QOL is a questionnaire that measures the impact of UF symptoms, including measures of heavy menstrual bleeding on quality of life across 2 scales: HRQoL and symptom severity.14,15

UFS-QOL data from ELARIS UF-1 and UF-2 was a non-ranked endpoint that was not controlled for multiplicity.2

In a study evaluating the UFS-QOL questionnaire, which includes heavy menstrual bleeding measures, 29 control patients had an average symptom severity score of 23 and an average HRQoL total score of 86.14

UFS-QOL=Uterine Fibroid Symptom and Quality of Life.

Change in fibroid symptoms

PGIC questionnaire evaluated the assessment of whether severity of symptoms improved or worsened in premenopausal women who suffer from heavy menstrual bleeding due to fibroids18

PGIC results at Month 6 in ELARIS UF-218

Patients' assessment of whether severity of symptoms improved or worsened was a non-ranked endpoint and was not controlled for multiplicity.2

Click on a symptom to view results

Select a symptom to view results

Fibroid symptoms

PGIC=Patient Global Impression of Change.

BMI=body mass index; FIGO score=The International Federation of Gynecology and Obstetrics score for classifying leiomyomas.

*The ORIAHNN free trial provides a single 28-day trial supply of ORIAHNN at no cost to new patients residing in the United States with a valid prescription for an FDA-approved indication of ORIAHNN and who enroll in Oriahnn Complete. The trial is intended solely to allow new patients not currently taking ORIAHNN to determine with their healthcare provider whether ORIAHNN is right for them. There is no obligation to continue use of ORIAHNN after the trial has concluded and this program does not guarantee insurance coverage. Eligible patients are limited to one 28-day trial supply and may not re-enroll. The ORIAHNN trial supply will be dispensed only through an AbbVie-authorized pharmacy to the patient’s home address and may not be sold or further distributed. No claims for payment may be submitted to any third party insurance plan for product dispensed by program. AbbVie reserves the right to change or discontinue the trial at any time without notice. The trial is not health insurance and is not a discount, coupon, rebate or financial assistance program. Limitations may apply.

Final Month in ELARIS UF-1 and UF-2 is defined as the last 28 days before and including the last treatment visit date or the last dose date.

Submucosal: FIGO score 0-3; Intramural: FIGO score 4; Subserosal: FIGO score 5-8.

§Primary fibroid volume is defined as largest fibroid identified by ultrasound.

||A uterus that is 14-16 weeks in size is approximately 355-460 cm3.

For primary fibroid volume only, N=778.

#A >2 g/dL increase in Hgb levels.

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

  • ORIAHNN is contraindicated in women at a high risk of arterial, venous thrombotic, or thromboembolic disorders; who are pregnant; with 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, angioedema, or hypersensitivity to ingredients of ORIAHNN; or with concomitant use of organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase elagolix plasma concentrations.

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders and Vascular 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. Components of ORIAHNN increase the risk of thrombotic or thromboembolic disorders, including pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at high risk for these events. In general, the risk is greatest among women over 35 years of age who smoke, and women with uncontrolled hypertension, dyslipidemia, vascular disease, or obesity.
  • Discontinue ORIAHNN if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs. If feasible, discontinue ORIAHNN at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. Stop ORIAHNN if there is sudden, unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately.

Bone Loss

  • ORIAHNN is contraindicated in women with known osteoporosis. ORIAHNN may cause a decrease in bone mineral density (BMD) in some patients, which is greater with increasing duration of use and may not be completely reversible after stopping treatment.
  • The impact of ORIAHNN-associated decreases in BMD on long-term bone health and future fracture risk is unknown. Consider the benefits and risks of ORIAHNN in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss, including those taking medications that may decrease BMD (e.g., systemic or chronic inhaled corticosteroids, anticonvulsants, or proton pump inhibitors).
  • Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing ORIAHNN if the risk associated with bone loss exceeds the potential benefit of treatment. Limit the duration of use to 24 months to reduce the extent of bone loss.

Hormonally Sensitive Malignancies

  • ORIAHNN is contraindicated in women with current or a history of breast cancer and in women at increased risk for hormonally sensitive malignancies, such as those with mutations in BRCA genes.
  • The use of estrogen alone and estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. Surveillance measures, such as breast examinations and regular mammography, are recommended. Discontinue ORIAHNN if a hormonally sensitive malignancy is diagnosed.

Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders

  • Depression, depressed mood, and/or tearfulness were reported at a higher incidence in women taking ORIAHNN (3%) compared with placebo (1%) in the Phase 3 clinical trials. Suicidal ideation and behavior, including a completed suicide, occurred in women treated with lower doses of elagolix in clinical trials conducted for a different indication.
  • Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate.
  • Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing ORIAHNN if such events occur.

Hepatic Impairment and Transaminase Elevations

  • ORIAHNN is contraindicated in women with known hepatic impairment or disease.
  • Transaminase elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) occurred with ORIAHNN in Phase 3 clinical trials. No pattern in time to onset of these liver transaminase elevations was identified. Transaminase levels returned to baseline within 4 months after peak values in these patients.
  • Instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice.

Elevated Blood Pressure

  • ORIAHNN is contraindicated in women with uncontrolled hypertension. Maximum mean increases in systolic blood pressure occurred at Month 5, and a mean maximum increase in diastolic blood pressure occurred at Month 4 in ORIAHNN-treated women, as compared to placebo-treated women.
  • For women with well-controlled hypertension, continue to monitor blood pressure and stop ORIAHNN if blood pressure rises significantly. Monitor blood pressure in normotensive women treated with ORIAHNN.

Gallbladder Disease or History of Cholestatic Jaundice

  • Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Discontinue ORIAHNN if jaundice occurs.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy

  • ORIAHNN may delay the ability to recognize the occurrence of a pregnancy because it may reduce the intensity, duration, and amount of menstrual bleeding. Perform pregnancy testing if pregnancy is suspected and discontinue ORIAHNN if pregnancy is confirmed.
  • The effect of hormonal contraceptives on the efficacy of ORIAHNN is unknown. Advise women to use non-hormonal contraception during treatment and for 1 week after discontinuing ORIAHNN.

Effects on Carbohydrate and Lipid Metabolism

  • ORIAHNN may decrease glucose tolerance and result in increased glucose levels. More frequent monitoring in ORIAHNN-treated women with prediabetes and diabetes may be needed.
  • In women with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Use of elagolix is associated with increases in total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and serum triglycerides. Monitor lipid levels and consider discontinuing ORIAHNN if hypercholesterolemia or hypertriglyceridemia worsens.

Alopecia

  • In Phase 3 clinical trials, more women experienced alopecia, hair loss, and hair thinning with ORIAHNN (3.5%) compared to placebo (1.0%). In almost one-third of affected ORIAHNN-treated women, alopecia was the reason for discontinuing treatment. No specific pattern was described. In the majority of these women, hair loss was continuing when ORIAHNN was stopped. Whether the hair loss is reversible is unknown. Consider discontinuing ORIAHNN if hair loss becomes a concern.

Effect on Other Laboratory Results

  • The use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce the free thyroid or corticosteroid hormone levels. Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy, respectively.
  • The use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, coagulation factors, lipids, and glucose.

RISK OF ALLERGIC REACTIONS DUE TO THE INACTIVE INGREDIENT (FD&C YELLOW NO. 5)

  • ORIAHNN contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

ADVERSE REACTIONS

  • Most common adverse reactions occurring in ≥5% of women receiving ORIAHNN in clinical trials were hot flush, headache, fatigue, and metrorrhagia.

These are not all of the possible side effects of ORIAHNN.

Safety and effectiveness of ORIAHNN in pediatric patients have not been established.

US-GYNUF-200028

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.

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.

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…

INDICATION1

ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas in premenopausal women…

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.

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…

INDICATION1

ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas in premenopausal women…

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

  • ORIAHNN is contraindicated in women at a high risk of arterial, venous thrombotic, or thromboembolic disorders; who are pregnant; with 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, angioedema, or hypersensitivity to ingredients of ORIAHNN; or with concomitant use of organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase elagolix plasma concentrations.

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders and Vascular 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. Components of ORIAHNN increase the risk of thrombotic or thromboembolic disorders, including pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at high risk for these events. In general, the risk is greatest among women over 35 years of age who smoke, and women with uncontrolled hypertension, dyslipidemia, vascular disease, or obesity.
  • Discontinue ORIAHNN if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs. If feasible, discontinue ORIAHNN at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. Stop ORIAHNN if there is sudden, unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately.

Bone Loss

  • ORIAHNN is contraindicated in women with known osteoporosis. ORIAHNN may cause a decrease in bone mineral density (BMD) in some patients, which is greater with increasing duration of use and may not be completely reversible after stopping treatment.
  • The impact of ORIAHNN-associated decreases in BMD on long-term bone health and future fracture risk is unknown. Consider the benefits and risks of ORIAHNN in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss, including those taking medications that may decrease BMD (e.g., systemic or chronic inhaled corticosteroids, anticonvulsants, or proton pump inhibitors).
  • Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing ORIAHNN if the risk associated with bone loss exceeds the potential benefit of treatment. Limit the duration of use to 24 months to reduce the extent of bone loss.

Hormonally Sensitive Malignancies

  • ORIAHNN is contraindicated in women with current or a history of breast cancer and in women at increased risk for hormonally sensitive malignancies, such as those with mutations in BRCA genes.
  • The use of estrogen alone and estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. Surveillance measures, such as breast examinations and regular mammography, are recommended. Discontinue ORIAHNN if a hormonally sensitive malignancy is diagnosed.

Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders

  • Depression, depressed mood, and/or tearfulness were reported at a higher incidence in women taking ORIAHNN (3%) compared with placebo (1%) in the Phase 3 clinical trials. Suicidal ideation and behavior, including a completed suicide, occurred in women treated with lower doses of elagolix in clinical trials conducted for a different indication.
  • Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate.
  • Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing ORIAHNN if such events occur.

Hepatic Impairment and Transaminase Elevations

  • ORIAHNN is contraindicated in women with known hepatic impairment or disease.
  • Transaminase elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) occurred with ORIAHNN in Phase 3 clinical trials. No pattern in time to onset of these liver transaminase elevations was identified. Transaminase levels returned to baseline within 4 months after peak values in these patients.
  • Instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice.

Elevated Blood Pressure

  • ORIAHNN is contraindicated in women with uncontrolled hypertension. Maximum mean increases in systolic blood pressure occurred at Month 5, and a mean maximum increase in diastolic blood pressure occurred at Month 4 in ORIAHNN-treated women, as compared to placebo-treated women.
  • For women with well-controlled hypertension, continue to monitor blood pressure and stop ORIAHNN if blood pressure rises significantly. Monitor blood pressure in normotensive women treated with ORIAHNN.

Gallbladder Disease or History of Cholestatic Jaundice

  • Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Discontinue ORIAHNN if jaundice occurs.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy

  • ORIAHNN may delay the ability to recognize the occurrence of a pregnancy because it may reduce the intensity, duration, and amount of menstrual bleeding. Perform pregnancy testing if pregnancy is suspected and discontinue ORIAHNN if pregnancy is confirmed.
  • The effect of hormonal contraceptives on the efficacy of ORIAHNN is unknown. Advise women to use non-hormonal contraception during treatment and for 1 week after discontinuing ORIAHNN.

Effects on Carbohydrate and Lipid Metabolism

  • ORIAHNN may decrease glucose tolerance and result in increased glucose levels. More frequent monitoring in ORIAHNN-treated women with prediabetes and diabetes may be needed.
  • In women with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Use of elagolix is associated with increases in total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and serum triglycerides. Monitor lipid levels and consider discontinuing ORIAHNN if hypercholesterolemia or hypertriglyceridemia worsens.

Alopecia

  • In Phase 3 clinical trials, more women experienced alopecia, hair loss, and hair thinning with ORIAHNN (3.5%) compared to placebo (1.0%). In almost one-third of affected ORIAHNN-treated women, alopecia was the reason for discontinuing treatment. No specific pattern was described. In the majority of these women, hair loss was continuing when ORIAHNN was stopped. Whether the hair loss is reversible is unknown. Consider discontinuing ORIAHNN if hair loss becomes a concern.

Effect on Other Laboratory Results

  • The use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce the free thyroid or corticosteroid hormone levels. Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy, respectively.
  • The use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, coagulation factors, lipids, and glucose.

RISK OF ALLERGIC REACTIONS DUE TO THE INACTIVE INGREDIENT (FD&C YELLOW NO. 5)

  • ORIAHNN contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

ADVERSE REACTIONS

  • Most common adverse reactions occurring in ≥5% of women receiving ORIAHNN in clinical trials were hot flush, headache, fatigue, and metrorrhagia.

These are not all of the possible side effects of ORIAHNN.

Safety and effectiveness of ORIAHNN in pediatric patients have not been established.

US-GYNUF-200028

Please see Full Prescribing Information.