Orilissa 200 mg tablet

Generic name:
Elagolix - oral

Pronunciation
(EL-a-GOE-lix)

Brand name(s)
Orilissa

This medication is used by women to help relieve moderate to severe pain due to a condition called endometriosis. Endometriosis is the growth of tissue that normally lines the inside of the womb (uterus) in a different place, such as on the outside surface of the uterus, on the ovaries, or on other organs. This condition may cause symptoms such as painful/heavy/irregular menstrual periods, pain during or after sex, or infertility. Elagolix works by decreasing your body's production of certain hormones (luteinizing hormone, follicle-stimulating hormone), which leads to lower amounts of female sex hormones (estrogens). These lower levels may help decrease some symptoms of endometriosis.

Read the Medication Guide provided by your pharmacist before you start taking elagolix and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

To make sure you are not pregnant, your doctor may do a pregnancy test before you start taking this medication, or tell you to start taking it within 7 days after the start of your menstrual period. Start taking this medication only when directed by your doctor.

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily. The dosage and length of treatment are based on your medical condition, response to treatment, and other drugs you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To lessen the risk of bone loss, this medication is usually taken for up to 6 months or up to 24 months. Talk with your doctor for details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if your condition does not get better or if it gets worse.

Nausea, trouble sleeping, hot flashes, night sweats, headache, or menstrual period changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as new or worsening depression, anxiety, unusual changes in behavior)
• signs of liver damage (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Get medical help right away if you have any very serious side effects, including:

• thoughts of suicide

This medication lowers estrogen levels in your body. Low estrogen levels can lead to bone loss. The risk is increased with higher doses or with longer use of this medication. Some bone loss may be permanent, so you should take this medication at the lowest effective dose. Talk with your doctor about the risks and benefits of taking this medication, and ask about taking calcium supplements and vitamin D for bone health.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking elagolix, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems
• bone loss (osteoporosis)
• mental/mood disorders (such as depression)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. Elagolix may harm an unborn baby. Ask about reliable forms of non-hormonal birth control (such as condoms, spermicide) while using this medication and for 4 weeks after stopping treatment. Because this medication affects menstruation, it may be harder to tell if you are pregnant. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of elagolix from your body, which may affect how elagolix works. Examples include asciminib, belumosudil, cyclosporine, encorafenib, gemfibrozil, letermovir, resmetirom, vadadustat, voclosporin, among others.

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include daridorexant, elacestrant, certain drugs for hepatitis C (such as asunaprevir, ombitasvir/paritaprevir/ritonavir), mavacamten, quizartinib, revumenib, among others.

Hormonal birth control may interact with this medication. Women of childbearing age should talk with the doctor about using reliable forms of non-hormonal birth control.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, cholesterol, pregnancy test, bone density tests) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember if it is on the same day. If you do not remember until the next day, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator or at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.