Medically reviewed by Drugs.com. Last updated on Apr 20, 2023.
What is Orilissa?
Orilissa binds to the same receptors in the body as a certain hormone that stimulates the production of 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 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;
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.
Related/similar drugsnorethindrone, medroxyprogesterone, Provera, leuprolide, Sprintec, Lupron Depot
How should I take Orilissa?
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
-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.
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 to avoid
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Orilissa side effects
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
Common Orilissa side effects may include:
hot flush or night sweats;
missed menstrual periods;
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 Orilissa?
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.
Elagolix (brand name: Orilissa) is used to treat moderate to severe endometriosis (endo) pain. Endometriosis is a chronic disease for which there is currently no cure. Elagolix for endometriosis pain was approved by the FDA in June 2018. It works by blocking the effects of GnRH (gonadotropin-releasing hormone) and reducing estrogen production, which may help to lower your endo pain.
Elagolix can be used to treat uterine fibroids when it is given as the brand Oriahnn which combines elagolix with estradiol and norethindrone acetate. Elagolix, as the brand Orlissa, is only approved to treat endometriosis-associated pain.
Elagolix is approved to help reduce endometriosis-associated pain, and research has also shown that it can reduce heavy menstrual bleeding in women with fibroids although this is not without side effects. Women with uterine fibroids were treated with Elagolix in addition to hormonal “Add-back” therapy for 6 months. 68.5% in one study and 76.5% in the other reported at least a 50% reduction in menstrual blood loss from the start of the study to the final month and a menstrual blood loss of less than 80mL by the final month of the study. Using Elagolix to reduce heavy menstrual bleeding is an unapproved use for the drug. Continue reading
Non-hormonal birth control methods (contraceptives) should be used during treatment with Orilissa (elagolix) and for one week after to prevent pregnancy. Non-hormonal birth control methods include condoms and spermicides. Continue reading
More about Orilissa (elagolix)
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- Drug class: gonadotropin-releasing hormone antagonists
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Orilissa only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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