Elagolix (el-a-GOE-lix)

Treats moderate to severe pain caused by endometriosis.

Brand Name(s):

Orilissa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Use this medicine within 7 days from the start of your menstrual period.
• You may receive other medicines (including calcium or vitamin D supplements) to help reduce bone loss.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not flush this medicine down the toilet.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with cyclosporine or gemfibrozil.
• Some medicines can affect how elagolix works. Tell your doctor if you are using digoxin, ketoconazole, oral midazolam, omeprazole, rifampin, rosuvastatin, or birth control pills (including ethinyl estradiol, levonorgestrel, norelgestromin, norethindrone, norgestrel).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms or spermicide) along with your pills. Use an effective form of birth control during treatment with this medicine and for at least 28 days after the last dose.
• Tell your doctor if you are breastfeeding, or if you have a history of depression or suicide.
• This medicine may cause the following problems:
  • Lower bone mineral density
  • Changes in menstrual bleeding, which may decrease your ability to recognize the occurrence of a pregnancy
  • Changes in behavior or mood, including thoughts of suicide
  • Liver problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone pain, decreased height
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme energy or restlessness, confusion, agitation, unusual mood or behavior
• Light, heavy, or irregular bleeding during monthly periods

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint pain
• Sweating, warmth or redness in your face, neck, arms, or upper chest
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088