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Oriahnn

Oriahnn is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Limitation of Use:

Use of Oriahnn should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].

Oriahnn Dosage and Administration Important Dosing Information
  • Exclude pregnancy before starting Oriahnn or start Oriahnn within 7 days from the onset of menses [see Use in Specific Populations (8.1) and (8.3)].
  • The recommended dosage of Oriahnn is:
    • One elagolix 300 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg capsule in the morning (AM), and
    • One elagolix 300 mg capsule in the evening (PM).
  • Take the morning and evening capsules at approximately the same time each day, with or without food.
  • The recommended duration of treatment with Oriahnn is 24 months [see Warnings and Precautions (5.2)].
Missed Dose

Instruct the patient to take the missed dose of Oriahnn within 4 hours of the time that it was supposed to be taken and then the next dose at the usual time. If more than 4 hours have passed since a capsule is usually taken, instruct the patient not to takethe missed dose and take the next dose at the usual time. Take only one morning capsule and one evening capsule per day.

Dosage Forms and Strengths

Oriahnn consists of two capsules:

  • The morning (AM) capsule is white and yellow, printed with “EL300 AM” containing 300 mg elagolix, 1 mg estradiol, and 0.5 mg norethindrone acetate.
  • The evening (PM) capsule is white and light blue, printed with “EL300 PM” containing 300 mg elagolix.
Contraindications

Oriahnn is contraindicated in women:

  • With a high risk of arterial, venous thrombotic, or thromboembolic disorders [see Boxed Warning and Warnings and Precautions (5.1)]. Examples include women over 35 years of age who smoke, and women who are known to have:
    • current or history of deep vein thrombosis or pulmonary embolism
    • vascular disease (e.g., cerebrovascular disease, coronary artery disease, peripheral vascular disease)
    • thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
    • inherited or acquired hypercoagulopathies
    • uncontrolled hypertension
    • headaches with focal neurological symptoms or have migraine headaches with aura if over age 35
  • Who are pregnant. Exposure to Oriahnn early in pregnancy may increase the risk of early pregnancy loss [see Use in Specific Populations (8.1)].
  • With known osteoporosis because of the risk of further bone loss [see Warnings and Precautions (5.2)].
  • With current or history of breast cancer or other hormonally-sensitive malignancies, and with increased risk for hormonally-sensitive malignancies [see Warnings and Precautions (5.3)].
  • With known hepatic impairment or disease [see Warnings and Precautions (5.5)].
  • With undiagnosed abnormal uterine bleeding.
  • With known anaphylactic reaction, angioedema, or hypersensitivity to Oriahnn or any of its components.
  • Taking inhibitors of organic anion transporting polypeptide (OATP)1B1 (a hepatic uptake transporter) that are known or expected to significantly increase elagolix plasma concentrations [see Drug Interactions (7.2)].
Warnings and Precautions Thromboembolic Disorders and Vascular Events

Oriahnn is contraindicated in women with current or history of thrombotic or thromboembolic disorders and in women at increased risk for these events [see Contraindications (4)]. In the Phase 3 clinical trials (Studies UF-1, UF-2, and UF-3), two thrombotic events occurred in 453 Oriahnn-treated women (thrombosis in the calf and pulmonary embolism) [see Adverse Reactions (6.1) and Clinical Studies (14)]. Estrogen and progestin combinations, including the estradiol/norethindrone acetate component 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 or is suspected. 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 immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported in patients receiving estrogens and progestins.

Bone Loss

Oriahnn is contraindicated in women with known osteoporosis [see Contraindications (4)]. Oriahnn may cause a decrease in bone mineral density (BMD) in some patients. BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment [see Adverse Reactions (6.1)].

In the Phase 3 clinical trials (Studies UF-1, UF-2, and UF-3) [see Clinical Studies (14)], seven out of 453 (1.5%) Oriahnn-treated women experienced fractures, including one (0.2%) with a fragility fracture, compared to one out of 196 (0.5%) placebo-treated women (patient had a non-fragility fracture). Five of the seven Oriahnn-treated women reported these fractures in the post-treatment follow-up period. The impact of BMD decreases on long-term bone health and future fracture risk in premenopausal women is unknown.

Consider the benefits and risks of Oriahnn treatment in patients with a history of a low-trauma fracture or other risk factors for osteoporosis or bone loss, including 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 [see Indications and Usage (1) and Dosage and Administration (2.1)].

Although the effect of supplementation with calcium and vitamin D was not studied, such supplementation for patients with inadequate dietary intake may be beneficial.

Hormonally-Sensitive Malignancies

Oriahnn is contraindicated in women with current or history of breast cancer and in women at increased risk for hormonally-sensitive malignancies, such as those with mutations in BRCA genes [see Contraindications (4)].

In the Phase 3 clinical trials (Studies UF-1, UF-2, and UF-3), two (0.4%) cases of breast cancer in 453 Oriahnn-treated women were observed. No breast cancer cases were seen in placebo-treated women [see Adverse Reactions (6.1)].

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

In Phase 3 placebo-controlled clinical trials (Studies UF-1 and UF-2), Oriahnn-treated women had a higher incidence (3%) of depression, depressed mood, and/or tearfulness compared to placebo-treated women (1%) [see Adverse Reactions (6.1)]. 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

Contraindication in Patients with Hepatic Impairment

Oriahnn is contraindicated in women with known hepatic impairment or disease [see Contraindications (4), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

Transaminase Elevations

In Phase 3 placebo-controlled clinical trials (Studies UF-1 and UF-2), elevations (> 3 times the upper limit of the reference range) in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) occurred in 1.1% (4/379) and 1.3% (5/379) of Oriahnn-treated patients, respectively, compared to no elevations in placebo. Transaminases peaked at 8 times the upper limit for ALT and 6 times the upper limit for AST. 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 [see Adverse Reactions (6.1)].

Elevated Blood Pressure

Oriahnn is contraindicated in women with uncontrolled hypertension [see Contraindications (4)]. In Studies UF-1 and UF-2, a maximum mean increase in systolic blood pressure of 5.1 mmHg [95% confidence interval (CI) 2.68, 7.59] occurred at Month 5, and a maximum mean increase in diastolic blood pressure of 2.1 mmHg (95% CI 0.43, 3.84) occurred at Month 4 in Oriahnn-treated women, as compared to placebo-treated women [see Adverse Reactions (6.1)].

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 [see Adverse Reactions (6.1)]. Perform pregnancy testing if pregnancy is suspected, and discontinue Oriahnn if pregnancy is confirmed [see Use in Specific Populations (8.1, 8.3)].

The effect of hormonal contraceptives on the efficacy of Oriahnn is unknown. Advise women to use non-hormonal contraception during treatment and for one week after discontinuing Oriahnn [see Use in Specific Populations (8.1, 8.3)].

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 pre-existing 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 [see Adverse Reactions (6.1)].

Alopecia

In Phase 3 clinical trials (Studies UF-1 and UF-2), more women experienced alopecia, hair loss, and hair thinning with Oriahnn (3.5%) compared to placebo (1.0%). In almost one-third (4/14) of affected Oriahnn-treated women, alopecia was a reason for discontinuing treatment. No specific pattern was described. In the majority of affected 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 [see Adverse Reactions (6.1)].

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 [see Pharmacodynamics (12.2)].

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

The following serious adverse reactions are discussed elsewhere in labeling:

  • Thromboembolic Disorders and Vascular Events [see Warnings and Precautions (5.1)]
  • Bone Loss [see Warnings and Precautions (5.2)]
  • Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders [see Warnings and Precautions (5.4)]
  • Hepatic Transaminase Elevations [see Warnings and Precautions (5.5)]
  • Elevated Blood Pressure [see Warnings and Precautions (5.6)]
  • Effects on Carbohydrate and Lipid Metabolism [see Warnings and Precautions (5.9)]
  • Alopecia [see Warnings and Precautions (5.10)]
Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Oriahnn was evaluated in two 6-month, randomized, double-blind, placebo-controlled trials (Studies UF-1 and UF-2), in which 790 premenopausal women received at least 1 dose of Oriahnn (n=395), elagolix 300 mg twice daily (n=199), or placebo (n=196) [see Clinical Studies (14)]. Women who completed 6-month treatment in either Study UF-1 or Study UF-2 and met eligibility criteria (n=433) entered a 6-month extension study (Study UF-3), receiving either Oriahnn (n=276) or elagolix 300 mg twice daily (n=157). Elagolix 300 mg twice daily is not an approved dosage but was included as a reference arm. A total of 341women received Oriahnn for 6 months and 182 women received Oriahnn for 12 months.

Serious Adverse Events

Serious adverse events were reported in three (0.8%) Oriahnn-treated women in Studies UF-1 and UF-2. Two women had heavy menstrual bleeding and required blood transfusion due to anemia (0.5%) and one woman with history of bariatric surgery had a laparoscopic cholecystectomy due to cholelithiasis.

In Study UF-3, two women were diagnosed with breast cancer. One woman had completed 6 months of treatment with Oriahnn in Study UF-1 and received 34 additional days of Oriahnn in Study UF-3 when diagnosed. The second woman had received placebo in Study UF-2 and completed 6 months of Oriahnn in Study UF-3 when diagnosed [see Warnings and Precautions (5.3)].

Adverse Reactions Leading to Study Discontinuation

In Studies UF-1 and UF-2, the discontinuation rate due to adverse reactions was 10% among Oriahnn-treated women and 7% among placebo-treated women. The most common adverse reactions leading to study drug discontinuation in the Oriahnn group were nausea (1%), headache (1%), alopecia (1%), metrorrhagia (1%), menorrhagia (1%), and hot flush (1%). One event each of the following adverse reactions led to study drug discontinuation: affect lability, angina pectoris, depression, hepatic enzyme increased, homicidal ideation, hypertension, irritability, thrombosis.

In women who received Oriahnn in Studies UF-1 or UF-2 and then in Study UF-3, 4% discontinued treatment due to adverse reactions. Three women discontinued due to serious adverse events (one each for breast cancer, menorrhagia with pelvic pain, and hysterectomy).

Common Adverse Reactions

Adverse reactions reported in ≥5% of Oriahnn-treated women in Studies UF-1 and UF-2 and at a greater frequency than placebo-treated women are presented in Table 1.

Table 1. Adverse Reactions that Occurred in at Least 5% of Women with Uterine Fibroids Who Received Oriahnn in Studies UF-1 and UF-2 and at a Greater Incidence Than Placebo
Adverse Reaction Oriahnn
N=395
Placebo
N=196
Hot flush 22% 9%
Headache 9% 7%
Fatigue 6% 4%
Metrorrhagia 5% 1%

The most commonly reported adverse reactions in the blinded extension trial (Study UF-3) were consistent with those in the placebo-controlled trials.

Less Common Adverse Reactions

In Studies UF-1 and UF-2, adverse reactions reported in ≥3% and 3% was seen in 27% (48/175) of women and a decline of ≥8% was seen in 1.7% (3/175) of women.

To assess for recovery, the change in BMD over time was analyzed for women who received continuous Oriahnn treatment for up to 12 months and were then followed after cessation of therapy for an additional 12 months in Study UF-3 (Figure 1). The LS mean percent change from baseline in BMD 12 months after cessation of therapy was -0.72 (95% CI -1.2, -0.2), -0.59 (-1.0, -0.2), and -0.95 (-1.6, -0.3) at the lumbar spine, total hip, and femoral neck, respectively. Twelve months after cessation of Oriahnn, continued bone loss was observed at the lumbar spine, total hip, and femoral neck in 24%, 32%, and 40% of women, respectively. Partial recovery was observed in 46%, 33%, and 38% and full recovery was observed in 30%, 35%, and 22% of women at these same sites. The time to maximum recovery in women who partially recovered is unknown.


Figure 1. Mean Percent Change From Baseline in Lumbar Spine BMD in Women Who Received 12 Months of Oriahnn (On-Treatment) and 12 Months of Follow Up (Off Treatment)


Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders

In the placebo-controlled trials (Studies UF-1 and UF-2), Oriahnn was associated with adverse mood changes. Depression, depressed mood, and/or tearfulness were reported in 3% of Oriahnn-treated women compared to 1% of placebo-treated women. One woman treated with lower dose elagolix alone for another disease completed suicide 2 days after elagolix discontinuation.

Hepatic Transaminase Elevations

In Studies UF-1 and UF-2, elevations of serum ALT and AST with no concurrent elevations of bilirubin were reported.

  • ALT elevations to at least 3 times the upper limit of normal (ULN) occurred in 1.1% (4/379) of Oriahnn-treated women and no placebo-treated women. Peak elevation of ALT almost 8 times the ULN was reported in 1 Oriahnn-treated woman.
  • AST elevations to at least 3 times the ULN occurred in 5/379 (1.3%) in Oriahnn-treated women and no placebo-treated women. Peak elevation of AST 6 times the ULN was reported in 1 Oriahnn-treated woman.

Blood Pressure Elevations

There were more Oriahnn-treated women with systolic blood pressure ≥ 160 mmHg (7.1%) and diastolic blood pressure ≥ 100 mmHg (11.3%) compared to placebo-treated women (3.7% and 6.3%, respectively). The incidence of hypertensive adverse reactions was 3.8% in Oriahnn-treated women and 3.1% placebo-treated women. One Oriahnn-treated woman in Study UF-1, with no prior history but with elevated cholesterol levels, had severe hypertension (BP 204/112) and chest pain. ECG was negative. Her hypertension was controlled with anti-hypertensives and she completed Study UF-3.

Changes in Lipid Parameters

Increases in total cholesterol, low-density lipoprotein cholesterol (LDL-C), serum triglycerides, and apolipoprotein B were noted during Oriahnn treatment in Studies UF-1 and UF-2.

Of the women with Grade 0 LDL-C ( 2 g/dL in Hgb at Month 6   UF-1 UF-2   Oriahnn
n=52
(N=206) Placebo
n=31
(N=102) Oriahnn
n=48
(N=189) Placebo
n=24
(N=94) (%) at Month 6 62% 16% 50% 21% Difference from placebo %
          95% CI
          p-value 45%
(27, 64)
< 0.001   29%
(8, 51)
0.02   CI: confidence interval
n: number of subjects with Hgb ≤10.5 g/dL at Baseline and had Hgb measurements at Month 6
N: number of subjects in each treatment arm How Supplied/Storage and Handling

Oriahnn consists of two capsules: one to be taken in the morning (AM) and one to be taken in the evening (PM).

  • morning (AM) capsules are white and yellow, printed with “EL300 AM” and contain elagolix 300 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg.
  • evening (PM) capsules are white and light blue, printed with “EL300 PM” and contain elagolix 300 mg.

Oriahnn is packaged in weekly blister packs. Each blister pack contains seven AM capsules and seven PM capsules. Four blisters are packaged into a carton (NDC 0074-1017-56).

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15˚C to 30˚C (59˚F to 86˚F). [See USP Controlled Room Temperature].

Dispose unused medication via a take-back option if available. Otherwise, follow FDA instructions for disposing medication in the household trash, www.fda.gov/drugdisposal. Do NOT flush down the toilet.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Thromboembolic Disorders and Vascular Events

Advise patients that use of estrogen and progestin combinations may increase the risk of thromboembolic disorders and vascular events, especially in women at high risk for these events [see Boxed Warning, Contraindications (4), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

Bone Loss

Advise patients about the risk of bone loss. Advise patients that supplementary calcium and vitamin D may be beneficial if dietary intake of calcium and vitamin D is not adequate. Advise patients that oral iron supplement should not be taken at the same time as calcium and vitamin D [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

Suicidal Ideation and Exacerbation of Mood Disorders

Advise patients that suicidal ideation and exacerbation of mood disorders may occur with Oriahnn use. Instruct patients with new onset or worsening depression, anxiety, or other mood changes to promptly seek medical attention [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

Liver Injury

Advise patients to promptly seek medical attention in case of signs or symptoms that may reflect liver injury, such as jaundice [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)].

Change in Menstrual Bleeding Pattern

Advise patients that Oriahnn may delay the recognition of pregnancy because it may reduce the duration and amount of menstrual bleeding. Advise patients to use effective non-hormonal contraception while taking Oriahnn and to discontinue Oriahnn if pregnancy is diagnosed. Advise pregnant patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to Oriahnn during pregnancy [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1, 8.3)].

Alopecia

Advise patients that alopecia, hair loss, and hair thinning in no specific pattern, may occur with Oriahnn use. Advise patients that hair loss and hair thinning may not resolve completely after stopping Oriahnn. Advise patients to contact their healthcare provider if they have concerns about changes to their hair [see Warnings and Precautions (5.10) and Adverse Reactions (6.1)].

Drug Interactions

Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Advise patients to avoid grapefruit juice while taking Oriahnn [see Drug Interactions (7)].

Oriahnn Missed Dose Instructions

Instruct patients about what to do in the event a dose is missed. See “If you miss a dose of Oriahnn” section in FDA-approved Medication Guide.

Oriahnn Disposal Instructions

Instruct patients to dispose of unused medication via a take-back option if available or to otherwise follow FDA instructions for disposing of medication in the household trash, www.fda.gov/drugdisposal, and not to flush down the toilet.

Manufactured by AbbVie Inc. North Chicago, IL 60064

Oriahnn is a trademark of AbbVie Inc.

© 2020 AbbVie Inc. All rights reserved.

03-B969

MEDICATION GUIDE
Oriahnn (or-ee-ahn)
(elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules)
co-packaged for oral use
What is the most important information I should know about Oriahnn?
Oriahnn may cause serious side effects, including:
  • cardiovascular conditions
    • Oriahnn may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age and smoke, have uncontrolled high blood pressure, high cholesterol, diabetes, or are obese. Stop taking Oriahnn and call your healthcare provider right away or go to the nearest hospital emergency room right away if you have:
      • leg pain or swelling that will not go away
      • sudden shortness of breath
      • double vision, bulging of the eyes, sudden blindness, partial or complete
      • pain or pressure in your chest, arm, or jaw
      • sudden, severe headache unlike your usual headaches
      • weakness or numbness in an arm or leg, or trouble speaking
  • bone loss (decreased bone mineral density)
    • While you are taking Oriahnn, your estrogen levels may be low. Low estrogen levels can lead to bone mineral density loss.
    • If you have bone loss on Oriahnn, your bone density may improve after you stop taking Oriahnn, but complete recovery may not occur. It is unknown if these bone changes could increase your risk for broken bones as you age. For this reason, you should not take Oriahnn for more than 24 months.
    • Your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density when you start taking Oriahnn and periodically after you start.
    • Your healthcare provider may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle that promotes bone health. Iron supplements should not be taken at the same time that you take vitamin D and calcium supplements.
  • effects on pregnancy
    • Do not take Oriahnn if you are trying to become pregnant or are pregnant. It may increase the risk of early pregnancy loss.
    • If you think you may be pregnant, stop taking Oriahnn right away and call your healthcare provider.
      • If you become pregnant while taking Oriahnn, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-833-782-7241.
    • Oriahnn can decrease your menstrual bleeding or result in no menstrual bleeding at all, making it hard to know if you are pregnant. Watch for other signs of pregnancy such as breast tenderness, weight gain, and nausea.
    • Oriahnn does not prevent pregnancy. You will need to use effective methods of birth control while taking Oriahnn and for 1 week after you stop taking Oriahnn. Examples of effective methods can include condoms or spermicide, which do not contain hormones.
    • Talk to your healthcare provider about which birth control to use during treatment with Oriahnn. Your healthcare provider may change the birth control you were on before you start taking Oriahnn.
What is Oriahnn?
Oriahnn is a prescription medicine used to control heavy menstrual bleeding in premenopausal women (before “change of life” or menopause) with uterine fibroids.
It is not known if Oriahnn is safe and effective in children under 18 years of age.
Do not take Oriahnn if you:
  • have or have had:
    • stroke or a heart attack
    • a problem that makes your blood clot more than normal
    • blood circulation disorder
    • certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
    • blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
    • high blood pressure not well controlled by medicine
    • diabetes with kidney, eye, nerve, or blood vessel damage
    • certain kinds of headaches with numbness, weakness, or changes in vision or have migraine headaches with aura if you are over age 35
    • breast cancer or any cancer that is sensitive to female hormones
    • osteoporosis
    • unexplained vaginal bleeding that has not been diagnosed. Your healthcare provider should check any unexplained vaginal bleeding to find out the cause.
    • liver problems including liver disease
    • smoke and are over 35 years old
  • are taking medicines known as OATP1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix (an ingredient in Oriahnn). Ask your healthcare provider if you are not sure if you are taking this type of medicine.
  • have had a serious allergic reaction to elagolix, estradiol, norethindrone acetate, or any of the ingredients in Oriahnn. Ask your healthcare provider if you are not sure.
  • FD&C Yellow No.5 (tartrazine) is an ingredient in Oriahnn which may cause an allergic type reaction such as bronchial asthma in some patients who are also allergic to aspirin. See the end of this Medication Guide for a complete list of ingredients in Oriahnn.
Before you take Oriahnn, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had:
    • broken bones or other conditions that may cause bone problems.
    • depression, mood swings, or suicidal thoughts or behavior.
    • yellowing of the skin or eyes (jaundice) or jaundice caused by pregnancy (cholestasis of pregnancy).
  • are scheduled for surgery. Oriahnn may increase your risk of blood clots after surgery. Your doctor may advise you to stop taking Oriahnn before you have surgery. If this happens, talk to your healthcare provider about when to restart Oriahnn after surgery.
  • are pregnant or think you may be pregnant.
  • are breastfeeding. It is not known if Oriahnn can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take Oriahnn.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Women on thyroid or cortisol replacement therapy may need increased doses of the hormone.
Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take Oriahnn?
  • Take Oriahnn exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will give you a pregnancy test before you start taking Oriahnn or will have you start taking Oriahnn within 7 days after you start your period.
  • Take 1 white and yellow Oriahnn capsule in the morning and 1 white and light blue Oriahnn capsule in the evening each day.
  • Take Oriahnn at about the same time each morning and evening with or without food.
  • If you take too much Oriahnn, call your healthcare provider or go to the nearest hospital emergency room right away.
If you miss a dose of Oriahnn (morning or evening capsules):
  • Take the missed dose within 4 hours of the time that it was supposed to be taken. Then take the next dose at the usual time.
  • If more than 4 hours have passed since you usually take the morning or evening dose, skip the missed dose. Take your next dose at the usual time.
  • Do not take 2 doses to make up for the missed dose.
What should I avoid while taking Oriahnn?
  • Avoid grapefruit and grapefruit juice during treatment with Oriahnn since they may affect the level of Oriahnn in your blood, which may increase side effects.
What are the possible side effects of Oriahnn?
Oriahnn may cause serious side effects including:
  • See “What is the most important information I should know about Oriahnn?”
  • suicidal thoughts, suicidal behavior, and worsening of mood. Oriahnn may cause suicidal thoughts or actions. Call your healthcare provider or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you:
    • thoughts about suicide or dying
    • attempts to commit suicide
    • new or worse depression
    • new or worse anxiety
    • other unusual changes in behavior or mood
Pay attention to any changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.
  • abnormal liver tests. Call your healthcare provider right away if you have any of these signs and symptoms of liver problems:
    • jaundice
    • dark amber-colored urine
    • feeling tired (fatigue or exhaustion)
    • nausea and vomiting
    • generalized swelling
    • right upper stomach area (abdomen) pain
    • bruising easily
  • high blood pressure. You should see your healthcare provider to check your blood pressure regularly.
  • gallbladder problems (cholestasis), especially if you had cholestasis of pregnancy.
  • increases in blood sugar, cholesterol and fat (triglyceride) levels.
  • hair loss (alopecia). Hair loss and hair thinning can happen while taking Oriahnn and it can continue even after you stop taking Oriahnn. It is not known if this hair loss or hair thinning is reversible. Talk to your healthcare provider if this is a concern for you.
  • changes in laboratory tests including thyroid and other hormone, cholesterol, and blood clotting tests.
The most common side effects of Oriahnn include: hot flushes, headache, fatigue, and irregular periods.
These are not all the possible side effects of Oriahnn. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Oriahnn?
  • Store Oriahnn at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not keep medicine that is out of date or that you no longer need.
  • Dispose of unused medicines through community take-back disposal programs when available. If no community take-back disposal program is available go to www.fda.gov/drugdisposal for information on how to dispose of Oriahnn the right way.
  • Do not flush Oriahnn down the toilet.
Keep Oriahnn and all medicines out of the reach of children.
General information about the safe and effective use of Oriahnn.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Oriahnn for a condition for which it was not prescribed. Do not give Oriahnn to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Oriahnn that is written for health professionals.
What are the ingredients in Oriahnn?
Yellow/White AM Capsule:
Active ingredient: elagolix, estradiol, norethindrone acetate.
Inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and a gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5, FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water).

Light Blue/White PM Capsule:
Active ingredient: elagolix.
Inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc, purified water, and a gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water).
Manufactured by AbbVie Inc. North Chicago, IL 60064
Oriahnn is a trademark of AbbVie Inc.
For more information, go to www.Oriahnn.com or call 1-844-674-2466.

This Medication Guide has been approved by the                           Issued: May, 2020

U.S. Food and Drug Administration.

03-B969

NDC 0074-1017-56

Rx only

56 CAPSULES

FOR 28 DAYS IN 4 WEEKLY BLISTER PACKS

Oriahnn™

elagolix, estadiol and norethindrone acetate capsules and elagolix capsules 300 mg/1 mg/0.5 mg and 300 mg

Co-Packaged for Oral Use

300 mg / 1 mg / 0.5 mg  300mg

*Elagolix 300 mg (equivalent to 310 mg of elagolix sodium)

Contains FD&C Yellow No. 5 (Tartrazine) as a color additive

Each weekly blister pack contains 7 capsules to be taken in the morning

Each capsule contains elagolix* (300 mg), estradiol (1 mg) and norethindrone acetate (0.5 mg)

Each weekly blister pack contains 7 capsules to be taken in the evening

Each capsule contains elagolix* (300 mg)


Oriahnn 
elagolix and estradiol and norethisterone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0074-1017
Packaging
# Item Code Package Description
1 NDC:0074-1017-56 4 BLISTER PACK in 1 CARTON
1 1 KIT in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK
Part 2 1 BLISTER PACK
Part 1 of 2
Oriahnn 
elagolix and estradiol and norethisterone capsule
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELAGOLIX SODIUM (ELAGOLIX) ELAGOLIX SODIUM 300 mg
NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 0.5 mg
ESTRADIOL (ESTRADIOL) ESTRADIOL 1 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE  
POLYETHYLENE GLYCOL 3350  
CROSPOVIDONE, UNSPECIFIED  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
POLYVINYL ALCOHOL, UNSPECIFIED  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL, UNSPECIFIED  
TALC  
WATER  
LACTOSE MONOHYDRATE  
STARCH, CORN  
COPOVIDONE K25-31  
HYPROMELLOSE, UNSPECIFIED  
TRIACETIN  
FD&C RED NO. 40  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
GELATIN, UNSPECIFIED  
SHELLAC  
ALCOHOL  
ISOPROPYL ALCOHOL  
BUTYL ALCOHOL  
PROPYLENE GLYCOL  
AMMONIA  
FERROSOFERRIC OXIDE  
POTASSIUM HYDROXIDE  
Product Characteristics
Color WHITE (WHITE) , YELLOW (YELLOW) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code EL;300;AM
Contains     
Packaging
# Item Code Package Description
1 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213388 05/29/2020
Part 2 of 2
Oriahnn 
elagolix capsule
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELAGOLIX SODIUM (ELAGOLIX) ELAGOLIX SODIUM 300 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE  
POLYETHYLENE GLYCOL 3350  
CROSPOVIDONE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
POLYVINYL ALCOHOL, UNSPECIFIED  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL, UNSPECIFIED  
TALC  
WATER  
FD&C BLUE NO. 2  
FERRIC OXIDE YELLOW  
GELATIN, UNSPECIFIED  
SHELLAC  
ALCOHOL  
ISOPROPYL ALCOHOL  
BUTYL ALCOHOL  
PROPYLENE GLYCOL  
AMMONIA  
FERROSOFERRIC OXIDE  
POTASSIUM HYDROXIDE  
Product Characteristics
Color WHITE (White) , BLUE (Light Blue) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code EL;300;PM
Contains     
Packaging
# Item Code Package Description
1 7 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213388 05/29/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213388 05/29/2020
Labeler - AbbVie Inc. (078458370)
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