Orilissa (Elagolix Sodium)

They need to know if you have any of these conditions: -liver disease -mental illness -osteoporosis -suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member -an unusual or allergic reaction to elagolix, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

Take this medicine by mouth with a glass of water. You can take it with or without food. Follow the directions on the prescription label. Take this medicine at the same time each day. Do not take your medicine more often than directed. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Do not take this medicine with any of the following medications: -cyclosporine -gemfibrozil This medicine may also interact with the following medications: -certain antiviral medicines for hepatitis, HIV or AIDS -digoxin -female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections -midazolam -rifampin -rosuvastatin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your doctor or health care professional for regular checks on your progress. This medicine may cause weak bones (osteoporosis). Only use this product for the amount of time your health care professional tells you to. The longer you use this product the more likely you will be at risk for weak bones. Ask your health care professional how you can keep strong bones. You may have a change in bleeding pattern or irregular periods. Many females stop having periods while taking this drug. This medicine does not prevent pregnancy. Women must use effective birth control with this medicine. Use a non-hormonal form of birth control while taking this medicine and for 1 week after stopping it. Talk to your health care professional about how to prevent pregnancy. Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, call your health care professional.

Side effects that you should report to your doctor or health care professional as soon as possible: -allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue -anxious -depressed mood -signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin -suicidal thoughts or other mood changes Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome): -reduced or absent menstrual periods -headache -hot flashes or night sweats -nausea -joint pain -trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children. Store at room temperature between 2 and 30 degrees C (36 and 86 degrees F). Throw away any unused medicine after the expiration date on the label. Discard any unused medicine and used packaging carefully. Follow the directions in the MedGuide. Do NOT flush down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.