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The following safety and warning information outlines potential risks and precautions associated with the use of Orilissa (elagolix). It is crucial to understand these details and consult your healthcare provider with any questions or concerns.

• Bone Loss: Orilissa (elagolix) can lead to a reduction in bone mineral density, which might not fully recover after discontinuation. This risk increases with higher doses and prolonged use. Individuals with a history of osteoporosis should avoid using this medication.

• Menstrual Changes and Pregnancy Recognition: Users may experience lighter, shorter, or less frequent menstrual bleeding, which can complicate pregnancy detection. If pregnancy is suspected, take a test and cease using Orilissa (elagolix) if positive, informing your healthcare provider due to an increased risk of pregnancy loss if the drug is taken early in pregnancy.

• Mental Health Concerns: There is an elevated risk of depression, mood changes, and suicidal thoughts or behaviors. Notify your healthcare team immediately if you experience new or worsening mental health symptoms. If suicidal thoughts occur, seek emergency assistance by calling 911.

• Liver Health: Some users may experience elevated liver enzyme levels, indicating potential liver damage, especially at higher doses. Those with pre-existing liver issues should exercise caution.

• Interactions with Hormonal Birth Control: Orilissa (elagolix) may reduce the effectiveness of hormonal birth control, particularly those containing progestin. The interaction with progestin-only methods is uncertain, so consider using non-hormonal contraceptives to prevent pregnancy.

• Risk to Unborn Babies: This medication may increase the risk of pregnancy loss if taken during early pregnancy. Women of childbearing potential should confirm they're not pregnant before starting Orilissa (elagolix) and use effective non-hormonal contraception during treatment and for 28 days after the last dose.

Contraindications: Orilissa (elagolix) should not be used under the following conditions as it may lead to serious health risks:

• Current pregnancy
• Osteoporosis
• Severe liver impairment
• Concurrent use of certain medications that increase Orilissa (elagolix) levels in the body

Consult your healthcare provider if any of these conditions apply to you before starting this medication.

When taking this medication, some common side effects may occur, but they are usually mild and manageable. These include hot flashes, headaches, nausea, trouble sleeping, and changes in menstrual cycles. Additionally, some people may experience mood swings, a depressed mood, anxiety, joint pain, and a lower sex drive. Occasionally, individuals might notice diarrhea, stomach pain, constipation, weight gain, dizziness, and irritability. If these effects persist or become bothersome, it is advisable to consult with a healthcare provider for guidance.

While most people do not experience severe side effects, there are some serious reactions that require immediate medical attention. These include signs of liver damage, such as yellowing of the skin or eyes, persistent nausea or vomiting, loss of appetite, dark urine, and abdominal pain. A very serious allergic reaction is rare but can occur, with symptoms like rash, swelling of the face, tongue, or throat, and difficulty breathing. Mental health changes, including new or worsening depression, anxiety, unusual behavior, or thoughts of suicide, are also serious and necessitate urgent care.

This medication can lower estrogen levels, potentially leading to bone loss, which may be permanent with prolonged use. Discuss with your healthcare provider the risks and benefits of this medication, and consider taking calcium and vitamin D supplements to support bone health. Always report any new or unlisted side effects to your healthcare provider for further advice.

Elagolix can interact with various medications, potentially impacting how it functions. Some drugs, such as asciminib, belumosudil, cyclosporine, encorafenib, gemfibrozil, letermovir, resmetirom, vadadustat, and voclosporin, might alter the elimination process of elagolix from your body. This change can influence elagolix's effectiveness. Additionally, elagolix may accelerate the removal of certain other medications, potentially altering their effects. Affected drugs include daridorexant, elacestrant, mavacamten, quizartinib, and revumenib.

Furthermore, hormonal birth control methods may interact with elagolix. Women who are of childbearing age should consult their healthcare provider to discuss alternative, reliable non-hormonal birth control options.