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*Terms and Conditions apply. This benefit covers ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules). Eligibility: Available to patients with commercial insurance coverage for ORIAHNN who meet eligibility criteria. Co-pay assistance program is not available to patients receiving reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the ORIAHNN Savings Card and patient must call 1-800-ORIAHNN (1-800-674-2466) to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the ORIAHNN Savings Card program from any third-party payers. Offer subject to change or discontinuation without notice. Restrictions, including monthly maximums, may apply. Subject to all other terms and conditions, the maximum annual benefit that may be available solely for the patient’s benefit under the co-pay assistance program is $5,000.00 per calendar year. The actual application and use of the benefit available under the co-pay assistance program may vary on a monthly, quarterly, and/or annual basis depending on each individual patient’s plan of insurance and other prescription drug costs. This assistance offer is not health insurance. By redeeming this card, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer. To learn about AbbVie’s privacy practices and your privacy choices, visit https://privacy.abbvie
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.
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.
Reference: 1. ORIAHNN [package insert]. North Chicago, IL: AbbVie Inc.
ELARIS UF-1 and UF-2
ELARIS UF-EXTEND (UF-3)
BID=twice a day; E2/NETA=estradiol/norethindrone acetate.
*The reference arm was given elagolix 300 mg BID to characterize the impact of E2/NETA on efficacy and safety. This regimen is not commercially available and is not approved for use.
†Final Month in ELARIS UF-1 and UF-2 is defined as the last 28 days before and including the last dose date.
‡Final Month in ELARIS UF-EXTEND is defined as the last 28 days before and including the last dose date.
ORIAHNN was studied in an additional 6-month extension study (ELARIS UF-EXTEND), which did not include a placebo arm.1,3
Key exclusion criteria included a >8% decrease in BMD. There was no exclusion criteria based on efficacy results in ELARIS UF-1 and UF-2.3
BMD=bone mineral density.
Menstrual blood loss (MBL) in ELARIS UF-EXTEND3,19
Formal statistical hypothesis testing was not performed for the primary and secondary endpoints. Descriptive statistics were provided to summarize the primary and secondary endpoints.3
ORIAHNN was studied in an additional 6-month extension study (ELARIS UF-EXTEND), which did not include a placebo arm. Key exclusion criteria included a >8% decrease in BMD. There was no exclusion criteria based on efficacy results in ELARIS UF-1 and UF-2.1,3
Time interval since start of pivotal studies
Data reflect women taking ORIAHNN from baseline in ELARIS UF-1 and UF-2 who continued into ELARIS UF-EXTEND.3
BMD=bone mineral density.
ORIAHNN was studied in an additional 6-month extension study (ELARIS UF-EXTEND), which did not include a placebo arm. Key exclusion criteria included a >8% decrease in BMD. There was no exclusion criteria based on efficacy results in ELARIS UF-1 and UF-2.1,3
Women with baseline Hgb ≤10.5 g/dL were instructed to take supplemental iron.3
BMD=bone mineral density.
In ORIAHNN clinical trials, Amenorrhea was defined as having zero bleeding or spotting during the Final Month, which was a 28-day interval.2,3
ORIAHNN was studied in an additional 6-month extension study (ELARIS UF-EXTEND), which did not include a placebo arm. Key exclusion criteria included a >8% decrease in BMD. There was no exclusion criteria based on efficacy results in ELARIS UF-1 and UF-2.1,3
In ORIAHNN clinical trials, Amenorrhea was defined as having zero bleeding or spotting during the Final Month, which was a 28-day interval.2,3
ORIAHNN was studied in an additional 6-month extension study (ELARIS UF-EXTEND), which did not include a placebo arm. Key exclusion criteria included a >8% decrease in BMD. There was no exclusion criteria based on efficacy results in ELARIS UF-1 and UF-2.1,3
BMD=bone mineral density.
The Patient Global Impression of Change on Non-bleeding Uterine Fibroid Symptoms (PGIC-NBUFS) questionnaire is used to document the presence of and to assess the change in overall severity of non-bleeding symptoms and the severity of specific non-bleeding fibroid symptoms.
Since I started treatment, my [category] has/is:
The PGIC-NBUFS questionnaire was assessed at Month 1, Month 3, and Month 6 to measure non-bleeding symptoms in women with heavy bleeding due to fibroids:
• Abdominal or pelvic pain
• Abdominal or pelvic pressure
• Abdominal or pelvic cramping
• Back pain
• Abdominal bloating
Patients' assessment of whether severity of symptoms improved or worsened was a non-ranked endpoint and was not controlled for multiplicity.2
PGIC=Patient Global Impression of Change.
The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire measures the impact of UF symptoms, including measures of heavy menstrual bleeding, on quality of life. It includes 2 scales: health-related quality of life (HRQoL) and symptom severity. Both the HRQoL and symptom severity scale total scores range from 0 to 100.
*HRQoL subscales were grouped according to exploratory factor analysis, which is a statistical method that groups items into scales based on their degree of correlation with other items that measure the same underlying concepts.
UFS-QOL=Uterine Fibroid Symptom and Quality of Life.
