Pronunciation: EL a GOE lix

Brand: Orilissa

What is the most important information I should know about elagolix?

Do not use if you are pregnant. Elagolix may cause miscarriage.

Hormonal birth control methods (birth control pills, injections, implants) could make elagolix less effective. Use a condom or diaphragm with spermicide while you are taking elagolix and for at least 1 week after your last dose.

Elagolix can lower your estrogen levels, which may cause bone loss (osteoporosis). Talk with your doctor about ways to keep your bones healthy during and after treatment with this medicine.

What is elagolix?

Elagolix binds to the same receptors in the body as a certain hormone that stimulates the production of sex hormones. Elagolix works by lowering blood levels of estradiol and progesterone (female sex hormones).

Elagolix is used to treat moderate to severe pain caused by endometriosis.

Elagolix may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking elagolix?

You should not use elagolix if you are allergic to it, or if:

  • you have osteoporosis;
  • you are pregnant or may become pregnant;
  • you have severe liver disease; or
  • you also use certain other medicines such as cyclosporine, gemfibrozil, or rifampin.

You may need to have a negative pregnancy test before starting this treatment.

Do not use elagolix if you are pregnant, and tell your doctor right away if you become pregnant. This medicine may cause miscarriage.

Elagolix may change your menstrual periods, making it harder for you to know if you are pregnant. Other signs of pregnancy could include breast tenderness, nausea, and weight gain.

Birth control pills can make elagolix less effective. Use a condom or diaphragm with spermicide to prevent pregnancy while using elagolix and for at least 1 week after your last dose.

Tell your doctor if you have ever had:

  • a broken bone;
  • low bone mineral density;
  • depression or a mood disorder; or
  • suicidal thoughts or actions.

Elagolix can lower your estrogen levels, which may cause bone loss (osteoporosis). Talk with your doctor about ways to keep your bones healthy during and after treatment with this medicine.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I take elagolix?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Your dosing schedule may change if you switch to a different strength of this medicine. Follow your doctor's dosing instructions very carefully.

Store at room temperature away from moisture and heat.

Do not keep leftover elagolix that is no longer needed. Ask your pharmacist where to locate a drug take-back disposal program. Do not flush the unused tablets down the toilet.

What happens if I miss a dose?

Take the missed dose if you remember it later in the day. Otherwise, skip the missed dose and go back to your regular schedule. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking elagolix?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of elagolix?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • mood or behavior changes, anxiety, depression, or thoughts about suicide; or
  • liver problems --nausea, vomiting, stomach pain (upper right side), tiredness, easy bruising, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • hot flashes, night sweats;
  • missed menstrual periods;
  • mood changes;
  • headache, joint pain;
  • nausea; or
  • trouble sleeping.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect elagolix?

Tell your doctor about all your other medicines, especially:

  • birth control pills; or
  • birth control injections or implants.

This list is not complete. Other drugs may affect elagolix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about elagolix.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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