Orilissa
Orilissa (elagolix) is a hormone-free medication that's used to help manage moderate-to-severe pain caused by endometriosis. It belongs to a drug class called gonadotropin-releasing hormone (GnRH) antagonists. The medication is a tablet that's typically taken by mouth once or twice a day. Common side effects include hot flashes and headaches. It might also raise your risk of mood changes, and very rarely, suicidal thoughts. Orilissa (elagolix) can interact with many medications, including birth control pills.
What is Orilissa (elagolix)?
What is Orilissa (elagolix) used for?
Moderate-to-severe pain caused by endometriosis
How Orilissa (elagolix) works
Orilissa (elagolix) is a gonadotropin-releasing hormone (GnRH) antagonist. It blocks GnRH receptors in the brain from releasing various sex hormones, including estrogen, that play a role in endometriosis and the pain the condition causes. By lowering the levels of these sex hormones in the body, the medication helps relieve pain related to endometriosis.
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What are the side effects of Orilissa (elagolix)?
Common Side Effects
- Hot flash (24-46%)
- Headache (17-20%)
- Nausea (11-16%)
- Trouble sleeping (6-9%)
- Missing a menstrual period (4-7%)
- Mood swings (5-6%)
- Depressed mood (3-6%)
- Anxiety (3-5%)
- Joint pain (3-5%)
Other Side Effects
- Lower sex drive
- Diarrhea
- Stomach pain
- Constipation
- Weight gain
- Dizziness
- Irritability (crankiness)
Serious Side Effects
- Liver damage: yellowing of your skin and whites of your eyes, stomach pain, nausea, vomiting, loss of appetite, dark urine, tiredness
- Serious allergic reaction: rash; swelling of lips, tongue, or throat; trouble breathing
- New or worsening depression, anxiety, or other mood or behavior changes
- Suicidal thoughts or behavior
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Anxiety, nervousness
- Headache
- Hot flashes
- Joint pain
- Nausea
- Trouble sleeping
Pros and cons of Orilissa (elagolix)
Pros
Helps relieve pain due to endometriosis
Doesn't contain hormones
Taken once or twice a day
Cons
Might not feel pain relief right away (can take a month or longer)
Risk for bone loss with long-term treatment (can only take the medication for a set amount of time)
Approved for adults only
Pharmacist tips for Orilissa (elagolix)
Take Orilissa (elagolix) at the same time(s) each day with or without food. Food won't affect how well the medication works.
Speak to your prescriber about taking a calcium and vitamin D supplement while you're taking Orilissa (elagolix) to keep your bones strong. This medication can raise your risk of bone loss with higher doses and with longer treatment.
You might notice changes in your menstrual bleeding patterns while you're taking Orilissa (elagolix). Your periods might have less bleeding, be less intense, or be shorter in length. Or, you might not always have a period. This change can make it harder to tell whether you're pregnant if you're sexually active.
It's important to use non-hormonal birth control, like condoms or Paragard (copper intrauterine device), while you're taking Orilissa (elagolix) and for 28 days after your last dose. Orilissa (elagolix) can raise the risk for pregnancy loss if it's taken in the early stages of pregnancy, and the medication interacts with hormonal birth control. Stop taking Orilissa (elagolix) right away if you become pregnant during treatment.
Tell your care team if you notice any new or worsening depression, anxiety, or other unusual mood or behavior changes while you're taking Orilissa (elagolix). This medication can cause mood changes.
If you miss your Orilissa (elagolix) dose, take it as soon as you remember as long as it's within the same day as your missed dose. Don't double up on doses. Skip the missed dose if you remember a day or more later.
If you have any unused Orilissa (elagolix) left after your treatment ends, get rid of the medication by bringing it to a drug take-back location. You can also throw it away in your household trash after mixing the tablets with coffee grounds or cat litter in a sealed zipper bag. Don't flush unused Orilissa (elagolix) down the toilet.
Frequently asked questions about Orilissa (elagolix)
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What are the risks and warnings for Orilissa (elagolix)?
Orilissa (elagolix) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Bone loss
Risk factors: History of osteoporosis | Taking Orilissa (elagolix) for a long period of time | Taking a higher dose of Orilissa (elagolix)
Orilissa (elagolix) can cause bone loss (a decrease in bone mineral density). It's possible that the bone loss isn't completely reversible after you stop this medication. Your risk is higher if you're taking a higher dose and if you take the medication for a long period of time. You shouldn't take Orilissa (elagolix) if you have a history of osteoporosis
Because of the greater risk for bone loss with longer treatment, your prescriber will limit the amount of time you take Orilissa (elagolix) — either up to 6 months or 2 years, depending on your situation. To help further lower your risk, ask your prescriber about taking calcium and vitamin D supplements during therapy. Your prescriber can also recommend other ways to keep your bones healthy.
Change in menstrual bleeding pattern and effect on recognizing pregnancy
People who take Orilissa (elagolix) might have less bleeding during their monthly menstrual periods. The periods might also be less intense or shorter than usual. These changes can make it harder to tell whether you're pregnant or not. Take a pregnancy test if you think you might be pregnant. And stop taking Orilissa (elagolix) and let your prescriber know if the results of the test say that you're pregnant. This is important because the medication might raise the risk for pregnancy loss if it's taken early in pregnancy.
Suicidal thoughts or behavior or worsened mood problems
Risk factors: History of depression or suicidal behaviors
Orilissa (elagolix) can raise your risk of depression, mood changes, and suicidal thoughts or behavior. Let your care team know right away if you or your loved ones notice that you have any new or worsening depression, anxiety, or other unusual mood or behavior changes while you're taking Orilissa (elagolix). Your prescriber will discuss with you about whether you should continue taking this medication and whether you should speak with a mental health professional. Call 911 as soon as possible if you have suicidal thoughts or behaviors.
Liver damage
Risk factors: Liver problems | High dose
In clinical studies, some people who took Orilissa (elagolix) had elevated liver enzyme levels, which can be a sign of liver damage. You're at higher risk if you're taking a higher dose of Orilissa (elagolix).
To be safe, you should take Orilissa (elagolix) at the lowest dose possible to manage your symptoms. Get medical help right away if you have nausea, vomiting, stomach pain, poor appetite, or yellowing of your skin or whites of your eyes. These can be signs of liver damage. Your care team will check your liver health through blood tests to decide whether to continue treatment.
Interactions with hormonal birth control
Risk factors: Taking Orilissa (elagolix) with birth control containing estrogen or progestin
Orilissa (elagolix) can interact with hormonal birth control. It can make the progestin in combined hormonal birth control work less well, putting you at risk for an accidental pregnancy if you're sexually active. It's not clear what the effects of taking progestin-only birth control (e.g., pills, implants, intrauterine devices) with Orilissa (elagolix) are.
Orilissa (elagolix) can also make the levels of estrogen from hormonal birth control higher in the body and raise the risk for side effects from estrogen. In addition, hormonal birth control might make Orilissa (elagolix) work less well for endometriosis symptoms.
Because of these interactions, it's recommended to use effective non-hormonal birth control methods, like condoms or spermicide. Work with your prescriber to find safe birth control options that best fit your needs while you're taking Orilissa (elagolix).
Risk of harm to unborn baby
Orilissa (elagolix) might raise the risk for pregnancy loss if it's taken early in pregnancy. If you're able to have children, your prescriber might ask you to take a pregnancy test to make sure you're not pregnant before you start taking this medication. Be sure to use effective non-hormonal birth control methods, like condoms, while you're taking Orilissa (elagolix) and for 28 days after your last dose.
Stop taking Orilissa (elagolix) and call your prescriber right away if you become pregnant while you're taking this medication. There's a pregnancy registry that you can enroll in that follows the progress of your health and your baby's health. This helps researchers learn more about the safety of the medication when it's been taken during pregnancy. Enroll in the pregnancy registry by calling 1-833-782-7241 or by visiting their website.
Orilissa (elagolix) dosage forms
Typical dosing for Orilissa (elagolix)
The typical starting dose is 150 mg by mouth once daily for 2 years.
Your dose might differ if you have genital pain during sex or liver problems. People with these conditions can take Orilissa (elagolix) for 6 months only.
How much does Orilissa (elagolix) cost?
Orilissa (elagolix) contraindications
Currently pregnant
Severe liver problems
Take certain medications that raise the levels of Orilissa (elagolix) in the body
What are alternatives to Orilissa (elagolix)?
Moderate-to-severe pain caused by endometriosis
Lack of menstrual periods due to hormonal imbalance (secondary amenorrhea)
Abnormal vaginal bleeding due to hormonal imbalance
Endometriosis
Before fibroid surgery to help improve anemia due to bleeding from uterine fibroids
What is the latest news about Orilissa (elagolix)?
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References
Best studies we foundAbbVie Inc. (2023). Orilissa- elagolix tablet, film coated [package insert]. DailyMed.
American College of Obstetricians and Gynecologists. (2021). Endometriosis.
Archer, D. F., et al. (2019). Elagolix suppresses ovulation in a dose-dependent manner: Results from a 3-month, randomized study in ovulatory women. Journal of Clinical Endocrinology & Metabolism.
Campbell, B. J., et al. (2024). Bone health basics. OrthoInfo.
DrugBank Online. (n.d.). OATP1B1/SLCO1B1 inhibitors.
Ford, B. (2019). Elagolix (Orilissa) for endometriosis pain. American Family Physician.
Leyland, N., et al. (2021). A clinician's guide to the treatment of endometriosis with Elagolix. Journal of Women's Health.
MedlinePlus. (2024). Bone density.
Shebley, M., et al. (2020). Clinical pharmacology of elagolix: An oral gonadotropin-releasing hormone receptor antagonist for endometriosis. Clinical Pharmacokinetics.
U.S. Food and Drug Administration. (2024). Where and how to dispose of unused medicines.
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