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INDICATIONORIAHNN (elagolix, estradiol, and norethindrone acetate capsules; elagolixcapsules) is indicated for the management of heavy menstrual bleedingassociated with uterine leiomyomas (fibroids) in premenopausal women. Useof ORIAHNN should be limited to 24 months due to the risk of continued boneloss, which may not be reversible.IMPORTANT SAFETY INFORMATIONTHROMBOEMBOLIC AND VASCULAR EVENTSEstrogen and progestin combinations, including ORIAHNN, increase the risk ofthrombotic or thromboembolic disorders, including pulmonary embolism, deep veinthrombosis, stroke, and myocardial infarction, especially in women at increased riskfor these events.ORIAHNN is contraindicated in women with current or a history of thrombotic orthromboembolic disorders and in women at increased risk for these events, includingwomen over 35 years of age who smoke and women with uncontrolled hypertension.CONTRAINDICATIONS ORIAHNN is contraindicated in women at a high risk of arterial, venousthrombotic, or thromboembolic disorders; who are pregnant; with knownosteoporosis; current or history of breast cancer or other hormonallysensitive malignancies; known hepatic impairment or disease; undiagnosedabnormal uterine bleeding; known anaphylactic reaction, angioedema, orhypersensitivity to ingredients of ORIAHNN; or with concomitant use oforganic anion transporting polypeptide (OATP) 1B1 inhibitors that are knownor expected to significantly increase elagolix plasma concentrations.WARNINGS AND PRECAUTIONSThromboembolic Disorders and Vascular Events ORIAHNN is contraindicated in women with current or a history ofthrombotic or thromboembolic disorders and in women at increased riskfor these events. Components of ORIAHNN increase the risk of thromboticor thromboembolic disorders, including pulmonary embolism, deep veinthrombosis, stroke, and myocardial infarction, especially in women at highrisk for these events. In general, the risk is greatest among women over35 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 least4 to 6 weeks before surgery of the type associated with an increased riskof thromboembolism, or during periods of prolonged immobilization. StopORIAHNN if there is sudden, unexplained partial or complete loss of vision,proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate forretinal vein thrombosis immediately.Bone Loss ORIAHNN is contraindicated in women with known osteoporosis. ORIAHNNmay cause a decrease in bone mineral density (BMD) in some patients,which is greater with increasing duration of use and may not be completelyreversible after stopping treatment. The impact of ORIAHNN-associated decreases in BMD on long-term bonehealth and future fracture risk is unknown. Consider the benefits and risksof ORIAHNN in patients with a history of low-trauma fracture or other riskfactors for osteoporosis or bone loss, including those taking medicationsthat 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) isrecommended at baseline and periodically thereafter. Consider discontinuingORIAHNN if the risk associated with bone loss exceeds the potential benefitof treatment. Limit the duration of use to 24 months to reduce the extent ofbone loss.Hormonally Sensitive Malignancies ORIAHNN is contraindicated in women with current or a history of breastcancer 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 reportedto result in an increase in abnormal mammograms requiring furtherevaluation. Surveillance measures, such as breast examinations and regularmammography, are recommended. Discontinue ORIAHNN if a hormonallysensitive malignancy is diagnosed.Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders Depression, depressed mood, and/or tearfulness were reported at a higherincidence in women taking ORIAHNN (3%) compared with placebo (1%) in thePhase 3 clinical trials. Suicidal ideation and behavior, including a completedsuicide, occurred in women treated with lower doses of elagolix in clinicaltrials conducted for a different indication. Promptly evaluate patients with depressive symptoms to determine whetherthe risks of continued therapy outweigh the benefits. Patients with new orworsening depression, anxiety, or other mood changes should be referred toa mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation andbehavior. Reevaluate the benefits and risks of continuing ORIAHNN if suchevents occur.Hepatic Impairment and Transaminase Elevations ORIAHNN is contraindicated in women with known hepatic impairmentor disease. Transaminase elevations in alanine aminotransferase (ALT) and aspartateaminotransferase (AST) occurred with ORIAHNN in Phase 3 clinical trials.No pattern in time to onset of these liver transaminase elevations wasidentified. Transaminase levels returned to baseline within 4 months afterpeak values in these patients. Instruct patients to promptly seek medical attention in case ofsymptoms 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 Month5, and a mean maximum increase in diastolic blood pressure occurredat Month 4 in ORIAHNN-treated women, as compared to placebotreated women. For women with well-controlled hypertension, continue to monitor bloodpressure and stop ORIAHNN if blood pressure rises significantly. Monitorblood pressure in normotensive women treated with ORIAHNN.Gallbladder Disease or History of Cholestatic Jaundice Studies among estrogen users suggest a small increased relativerisk of developing gallbladder disease. For women with a historyof cholestatic jaundice associated with past estrogen use or withpregnancy, assess the risk-benefit of continuing therapy. DiscontinueORIAHNN if jaundice occurs.Change in Menstrual Bleeding Pattern and Reduced Ability to RecognizePregnancy ORIAHNN may delay the ability to recognize the occurrence of apregnancy because it may reduce the intensity, duration, and amountof menstrual bleeding. Perform pregnancy testing if pregnancy issuspected and discontinue ORIAHNN if pregnancy is confirmed. The effect of hormonal contraceptives on the efficacy of ORIAHNN isunknown. Advise women to use non-hormonal contraception duringtreatment and for 28 days after discontinuing ORIAHNN.Effects on Carbohydrate and Lipid Metabolism ORIAHNN may decrease glucose tolerance and result in increasedglucose levels. More frequent monitoring in ORIAHNN-treated womenwith prediabetes and diabetes may be needed. In women with preexisting hypertriglyceridemia, estrogen therapymay be associated with elevations of plasma triglycerides leadingto pancreatitis. Use of elagolix is associated with increases in totalcholesterol, low-density lipoprotein cholesterol (LDL-C), high-densitylipoprotein cholesterol (HDL-C), and serum triglycerides. Monitor lipidlevels and consider discontinuing ORIAHNN if hypercholesterolemia orhypertriglyceridemia 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%). Inalmost one-third of affected ORIAHNN-treated women, alopecia was thereason for discontinuing treatment. No specific pattern was described.In the majority of these women, hair loss was continuing when ORIAHNNwas stopped. Whether the hair loss is reversible is unknown. Considerdiscontinuing ORIAHNN if hair loss becomes a concern.Effect on Other Laboratory Results The use of estrogen and progestin combinations may raise serumconcentrations of binding proteins (e.g., thyroid-binding globulin,corticosteroid-binding globulin), which may reduce the free thyroidor corticosteroid hormone levels. Patients with hypothyroidism andhypoadrenalism may require higher doses of thyroid hormone or cortisolreplacement therapy, respectively. The use of estrogen and progestin may also affect the levels of sexhormone-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 causeallergic-type reactions (including bronchial asthma) in certainsusceptible persons. Although the overall incidence of FD&C Yellow No.5 (tartrazine) sensitivity in the general population is low, it is frequentlyseen in patients who also have aspirin hypersensitivity.ADVERSE REACTIONS Most common adverse reactions occurring in 5% of women receivingORIAHNN in clinical trials were hot flush, headache, fatigue, andmetrorrhagia.These are not all of the possible side effects of ORIAHNN.Safety and effectiveness of ORIAHNN in pediatric patients have not beenestablished.Please see Full Prescribing Information at www.rxabbvie.com/pdf/oriahnn pi.pdf

Oriahnn Complete Terms and Conditions†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 foran FDA-approved indication of ORIAHNN and who enroll in Oriahnn Complete. The trial is intended solely to allow new patients not currently taking ORIAHNNto determine with their healthcare provider whether ORIAHNN is right for them. There is no obligation to continue use of ORIAHNN after the trial has concludedand this program does not guarantee insurance coverage. Eligible patients are limited to one 28-day trial supply and may not re-enroll. The ORIAHNN trialsupply 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 forpayment may be submitted to any third party insurance plan for product dispensed by program. AbbVie reserves the right to change or discontinue the trial atany time without notice. The trial is not health insurance and is not a discount, coupon, rebate or financial assistance program. Limitations may apply.‡Program is not available to patients receiving prescription 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 prohibitedby law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, orgovernment-funded healthcare program, patient will no longer be eligible to participate in program. Available to patients between the ages of 18-63 withcommercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with heavy menstrual bleeding related touterine fibroids in premenopausal women, have a valid prescription for ORIAHNN, and participate in a commercial insurance plan that has denied or not yetmade a formulary decision for ORIAHNN. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coveragerequests for ORIAHNN, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal ofthe coverage denial within 180 days. Program provides ORIAHNN at no charge to patients for up to 2 years or until they receive insurance coverage approval,whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance, and program does not guaranteeinsurance coverage.Prescriber Certification§I certify that ORIAHNN is medically necessary and that the diagnosis and other information provided is accurate to the best of my knowledge. I certify that I amthe prescriber who has prescribed ORIAHNN to the previously identified patient, and that I provided the patient with a description of the Oriahnn Completepatient support program. I authorize Oriahnn Complete to act on my behalf for the purposes of transmitting this prescription to the appropriate pharmacy. Iunderstand that the no-charge resource through Oriahnn Complete may support patients during the first month on treatment. I certify that I will not seekreimbursement from any third-party payer for any no-charge product dispensed by an AbbVie-authorized pharmacy.Please see Full Indication and Important Safety Information, includingBOXED WARNING on THROMBOEMBOLIC AND VASCULAR EVENTS, on page 2.Please see Full Prescribing Information at www.rxabbvie.com/pdf/oriahnn pi.pdf 2022 AbbVie Inc. North Chicago, IL 60064 US-ORIA-220055 March 2022

Welcome to Oriahnn Complete!Starting a medication can raise a lot ofquestions—that’s why we’re here to helpwhenever you may need us.Wondering what’s next?You may receive a call from Oriahnn Complete if additional informationis needed. To get your medication as soon as possible, please pick upour call. We’ll help you:1. Understand your insurance coverage for ORIAHNN.2. Navigate the steps needed to get your medication.3. Find possible ways to save on future ORIAHNN refills.(You could pay as little as 5* a month.)4. Get answers to your questions about ORIAHNN withpersonalized, one-on-one support by requesting anOriahnn Complete Nurse Ambassador.†You could save on your prescription.Request an Oriahnn Complete Savings card.Call 1-800-ORIAHNN.Please see ImportantSafety Information andaccompanying FullPrescribing Information,including Medication Guide,and discuss with your doctor.Have questions? Want to connect with a Nurse Ambassador†?Call 1-800-674-2466, Monday through Friday, 8 AM–8 PM ET.SAFETY CONSIDERATIONSORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35years of age and smoke, have uncontrolled high blood pressure, high cholesterol, diabetes, and/or are obese.Stop taking ORIAHNN and talk to a doctor right away if you have symptoms of a heart attack, stroke, orblood clot.*See Terms and Conditions on the last page.†Nurse Ambassadors are provided by AbbVie and do not work under the direction of your healthcare professional (HCP) or give medicaladvice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.Please see Important Safety Information on pages 6 and 7.Please see Full Prescribing Information, including MedicationGuide, at www.rxabbvie.com/pdf/oriahnn pi.pdf and discusswith your doctor.

Get one-on-one supportYour Nurse Ambassador† can help you stay on track with your prescribed treatmentplan and give you personalized support—right from the start. They can help you betterunderstand both your condition and ORIAHNN.Connect with a Nurse Ambassador by calling 1-800-ORIAHNN(1-800-674-2466), Monday through Friday, 8 am –8 pm ETFor more information, visit Oriahnn.comThe categories of personal information collected in the Enrollment and Prescription Form includecontact, insurance, prescription, and medical history information. The personal informationcollected will be used to provide and manage the Oriahnn Complete program and to performresearch and analytics on a de-identified basis. For more information about the categories ofpersonal information collected by AbbVie and the purposes for which AbbVie uses personalinformation, visit www.abbvie.com/privacy.html† urse Ambassadors are provided by AbbVie and do not work under the direction of your healthcare professional (HCP) or give medicalNadvice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.Please see Important Safety Information on pages 6 and 7.Please see Full Prescribing Information, including MedicationGuide, at www.rxabbvie.com/pdf/oriahnn pi.pdf and discusswith your doctor.

USEORIAHNN (elagolix, estradiol, and norethindroneacetate capsules; elagolix capsules) is aprescription medicine used to control heavymenstrual bleeding related to uterine fibroidsin women before menopause. It should not betaken for more than 24 months. It is not known ifORIAHNN is safe and effective in children under 18years of age.IMPORTANT SAFETY INFORMATIONWhat is the most important information I shouldknow about ORIAHNN?ORIAHNN may cause serious side effects,including: Cardiovascular Conditions– ORIAHNN may increase your chances of heartattack, stroke, or blood clots, especially ifyou are over 35 years of age and smoke,have uncontrolled high blood pressure, highcholesterol, diabetes, or are obese. Stop takingORIAHNN and call your healthcare providerright away or go to the nearest hospitalemergency 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, or suddenblindness (partial or complete) Pain or pressure in your chest, arm, or jaw Sudden, severe headache unlike your usualheadaches Weakness or numbness in an arm or leg, ortrouble speaking B one Loss (Decreased Bone Mineral Density[BMD])– While taking ORIAHNN, your estrogen levelsmay be low. Low estrogen levels can lead toBMD loss.– If you have bone loss on ORIAHNN, your BMDmay improve after you stop taking ORIAHNN,but complete recovery may not occur. It isunknown if these BMD changes could increaseyour risk for broken bones as you age. For thisreason, you should not take ORIAHNN for morethan 24 months.– Your healthcare provider may order an X-raytest called a DXA scan to check your bonemineral density when you start taking ORIAHNNand periodically after you start.– Your doctor may advise you to take vitamin Dand calcium supplements as part of a healthylifestyle. Effects on Pregnancy– Do not take ORIAHNN if you are pregnant ortrying to become pregnant, as it may increasethe risk of early pregnancy loss.– If you think you may be pregnant, stop takingORIAHNN right away and call your HCP.– ORIAHNN can decrease your menstrualbleeding or result in no menstrual bleeding atall, making it hard to know if you are pregnant.Watch for other pregnancy signs like breasttenderness, weight gain, and nausea.– ORIAHNN does not prevent pregnancy. You willneed to use effective methods of birth controlwhile taking ORIAHNN and for 28 days after youstop taking ORIAHNN. Examples of effectivemethods can include condoms or spermicide,which do not contain hormones.– Talk to your HCP about which birth control touse during treatment with ORIAHNN. Your HCPmay change the birth control you are on beforeyou start taking ORIAHNN.Do not take ORIAHNN if you: Have or have had:– A stroke or heart attack– A problem that makes your blood clot morethan normal– Blood circulation disorder– Certain heart valve problems or heart rhythmabnormalities that can cause blood clots toform in the heart– Blood clots in your legs (deep vein thrombosis),lungs (pulmonary embolism), or eyes (retinalthrombosis)– High blood pressure not well controlled bymedicine– Diabetes with kidney, eye, nerve, or bloodvessel damage– Certain kinds of headaches with numbness,weakness, or changes in vision, or havemigraine headaches with aura if you are overage 35– Breast cancer or any cancer that is sensitive tofemale hormones– Osteoporosis– Unexplained vaginal bleeding that has not beendiagnosed– Liver problems including liver disease Smoke and are over 35 years old Are taking medicines known as strong OATP1B1inhibitors that are known or expected tosignificantly increase the blood levels of elagolix.Ask your HCP if you are not sure if you are takingthis type of medicine. Have had a serious allergic reaction to elagolix,estradiol, norethindrone acetate, or any of theingredients in ORIAHNN. Ask your HCP if you arenot sure. FD&C Yellow No. 5 (tartrazine) is an ingredientin ORIAHNN, which may cause an allergic typePlease see additional Important Safety Information on page 7.reaction such as bronchial asthma in somePlease see Full Prescribing Information, including Medicationpatients who are also allergic to aspirin.Guide, at www.rxabbvie.com/pdf/oriahnn pi.pdf and discusswith your doctor.

IMPORTANT SAFETY INFORMATION (CONTINUED)What should I discuss with my HCP before takingORIAHNN?Tell your HCP about all your medical conditions,including if you: Have or have had:– Broken bones or other conditions that maycause bone problems– Depression, mood swings, or suicidal thoughtsor behavior– Yellowing of the skin or eyes (jaundice) orjaundice caused by pregnancy (cholestasisof pregnancy) Are scheduled for surgery. ORIAHNN mayincrease your risk of blood clots after surgery.Your doctor may advise you to stop takingORIAHNN before you have surgery. If thishappens, talk to your HCP about when to restartORIAHNN after surgery. Are pregnant or think you may be pregnant. Are breastfeeding. It is not known if ORIAHNNcan pass into your breastmilk. Talk to your HCPabout the best way to feed your baby if you takeORIAHNN.Tell your HCP about all the medicines you take,including prescription and over-the-countermedicines, vitamins, and herbal supplements.Women on thyroid or cortisol replacement therapymay need increased doses of the hormone.Keep a list of your medicines with you to show to yourHCP and pharmacist when you get a new medicine.What should I avoid while taking ORIAHNN? Avoid grapefruit and grapefruit juice duringtreatment with ORIAHNN since they may affectthe level of ORIAHNN in your blood, which mayincrease side effects.What are the possible side effects of ORIAHNN?ORIAHNN can cause additional serious sideeffects, including: Suicidal thoughts, suicidal behavior, andworsening of mood. ORIAHNN may causesuicidal thoughts or actions. Call your HCP orget emergency medical help right away if youhave any of these symptoms, especially if theyare new, worse, or bother you: thoughts aboutsuicide or dying, attempts to commit suicide, newor worse depression or anxiety, or other unusualchanges in behavior or mood. Pay attention toany changes, especially sudden changes, in yourmood, behaviors, thoughts, or feelings. A bnormal liver tests. Call your HCP right awayif you have any of these signs and symptomsof liver problems: jaundice, dark amber-coloredurine, feeling tired, nausea and vomiting,generalized swelling, right upper stomach areaPlease see additional Important Safety Information on page 6.Please see Full Prescribing Information, including MedicationGuide, at www.rxabbvie.com/pdf/oriahnn pi.pdf and discusswith your doctor. 2022 AbbVie Inc. North Chicago, IL 60064US-ORIA-220055 March 2022pain, or bruising easily. H igh blood pressure. You should see your HCP tocheck your blood pressure regularly. G allbladder problems (cholestasis), especially ifyou had cholestasis of pregnancy. I ncreases in blood sugar, cholesterol, and fat(triglyceride) levels. H air loss (alopecia). Hair loss and hair thinning canhappen while taking ORIAHNN, and it can continueeven after you stop taking ORIAHNN. It is notknown if this hair loss or hair thinning is reversible.Talk to your HCP if this is a concern for you. C hanges in laboratory tests, including thyroidand other hormone, cholesterol, and bloodclotting tests.The most common side effects of ORIAHNNinclude: hot flashes, headache, fatigue, andirregular periods.These are not all of the possible side effects ofORIAHNN. Tell your HCP if you have any side effectthat bothers you or that does not go away. Callyour HCP for medical advice about side effects.Take ORIAHNN exactly as your HCP tells you. Therecommended oral dosage of ORIAHNN is oneyellow/white capsule in the morning and one blue/white capsule in the evening, with or without food.This is the most important information to knowabout ORIAHNN. For more information, talk to yourdoctor or HCP.You are encouraged to report negative sideeffects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch or call 1-800-FDA-1088.If you are having difficulty paying for yourmedicine, AbbVie may be able to help. VisitAbbVie.com/myAbbVieAssist to learn more.Terms and Conditions apply. This benefit covers ORIAHNN (elagolix, estradiol, and norethindrone acetate capsules; elagolixcapsules). Eligibility: Available to patients with commercialprescription insurance coverage for ORIAHNN who meeteligibility criteria. Copay assistance program is not availableto patients receiving prescription reimbursement under anyfederal, state, or government-funded insurance programs(for example, Medicare [including Part D], Medicare Advantage,Medigap, Medicaid, TRICARE, Department of Defense, orVeterans Affairs programs) or where prohibited by law or bythe patient’s health insurance provider. If at any time a patientbegins receiving prescription drug coverage under any suchfederal, state, or government-funded healthcare program,patient will no longer be able to use the Oriahnn CompleteSavings Card and patient must call Oriahnn Complete at1-800-ORIAHNN and stop use of the copay card. Patientsresiding in or receiving treatment in certain states may not beeligible. Patients may not seek reimbursement for value receivedfrom ORIAHNN, including the copay card, from any third-partypayers. Offer subject to change or discontinuance withoutnotice. Restrictions, including monthly maximums, may apply.This is not health insurance.

INDICATION 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.