Orilissa binds to the same receptors in the body as a certain hormone that stimulates the production of sex hormones.

Orilissa works by lowering blood levels of estradiol and progesterone (female sex hormones).

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

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

Hormonal birth control methods (birth control pills, injections, implants) could make Orilissa 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.

Before taking this medicine

You should not use Orilissa if you are allergic to elagolix, 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 Orilissa if you are pregnant, and tell your doctor right away if you become pregnant. This medicine may cause miscarriage.

Orilissa 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.

To make sure Orilissa is safe for you, tell your doctor if you have:

• a broken bone;

• low bone mineral density;

• depression or a mood disorder; or

• suicidal thoughts or actions.

Orilissa 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.

Take Orilissa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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 Orilissa 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.

Usual Adult Dose for Endometriosis:

150 mg orally once a day for 24 months

For Women with Dyspareunia:
-Consider 200 mg orally twice a day for 6 months

Comments:
-Use lowest effective dose, considering the severity of symptoms and treatment objectives.
-The duration of treatment is limited because of bone loss.

Use: For the management of moderate to severe pain associated with endometriosis.

You should not use Orilissa if you are allergic to elagolix, 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 Orilissa if you are pregnant, and tell your doctor right away if you become pregnant. This medicine may cause miscarriage.

Orilissa 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.

To make sure Orilissa is safe for you, tell your doctor if you have:

• a broken bone;

• low bone mineral density;

• depression or a mood disorder; or

• suicidal thoughts or actions.

Orilissa 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.

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.

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

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

Get emergency medical help if you have signs of an allergic reaction to Orilissa: 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 Orilissa side effects may include:

• hot flush or night sweats;

• headache;

• nausea;

• insomnia;

• altered mood;

• mood swings;

• missed menstrual periods;

• depressed mood;

• anxiety; or

• joint pain.

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.

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 interact with elagolix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.