(el" a goe' lix)

Brand Name(s): Orilissa^®

WHY is this medicine prescribed?

Elagolix is used to manage pain due to endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding). Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of certain hormones in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Elagolix comes as a tablet to take by mouth. It is usually taken with or without food once daily for up to 24 months or twice daily for up to 6 months. Take elagolix at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take elagolix exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may prescribe or recommend a calcium and vitamin D supplement to take during your treatment. You should take these supplements as directed by your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking elagolix,

• tell your doctor and pharmacist if you are allergic to elagolix, any other medications, or any of the ingredients in elagolix tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking cyclosporine (Gengraf, Neoral, Sandimmune) or gemfibrozil (Lopid). Your doctor will probably tell you not to take elagolix if you are taking one of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: digoxin (Lanoxin), ketoconazole (Nizoral), midazolam, rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), and rosuvastatin (Crestor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with elagolix, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have osteoporosis (condition in which the bones become thin and weak and break easily), or if you have or have ever had liver disease. Your doctor may tell you not to take elagolix.

• tell your doctor if you have or have ever had broken bones, depression, anxiety, unusual changes in behavior or mood, or thoughts about or attempted suicide.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Do not take elagolix if you are pregnant or think you are pregnant. Your doctor will perform a pregnancy test prior to starting treatment or tell you to begin your treatment within 7 days after you start your menstrual period to be sure that you are not pregnant when you taking elagolix. Elagolix may interfere with the action of certain hormonal contraceptives, so you should not use these as your only method of birth control during your treatment. You will need to use a reliable non-hormonal method of birth control to prevent pregnancy during your treatment and for 1 week after your final dose. Ask your doctor to help you choose a method of birth control that will work for you. If you become pregnant while taking elagolix, call your doctor immediately. Elagolix may harm the fetus.

• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking elagolix. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening irritability, anxiety, or depression; talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose on the same day as soon as you remember it. Continue your regular dosing schedule. Do not take more than one dose each day (if you are taking it once a day) or more than two doses each day (if you are taking it twice a day). Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Elagolix may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• hot flashes (a sudden wave of mild or intense body heat)
• night sweats
• headache
• nausea
• diarrhea
• constipation
• stomach pain
• weight gain
• difficulty falling sleeping or staying asleep
• changes in menstrual periods (irregular bleeding or spotting, little or no bleeding, decreased length of periods)
• joint pain
• changes in sexual desire

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• yellow of skin or eyes; dark colored urine; extreme tiredness; nausea and vomiting; right upper abdomen pain; or unusual bleeding or bruising

Elagolix may cause or worsen osteoporosis. It can decrease the density of your bones and increase the chance of broken bones and fractures. Talk to your doctor about the risks of taking this medication.

Elagolix may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature or in the refrigerator (2–30°C) and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before and during your treatment to check your body's response to elagolix.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2018.