
Orilissa
Orilissa (elagolix) is a hormone-free medication used to help manage moderate or severe pain caused by endometriosis in adults. It belongs to a drug class called gonadotropin-releasing hormone (GnRH) antagonists. Orilissa (elagolix) comes as a tablet that's taken by mouth. It's taken once or twice a day, depending on other health conditions you have. Common side effects include hot flashes and headaches.
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 proteins in the brain called GnRH receptors. This blocks signals that tell the ovaries to make estrogen and progesterone. These hormones can play a role in endometriosis and the pain it causes.
By lowering these hormone levels, Orilissa (elagolix) can help relieve pain from endometriosis.
Drug facts
| Common Brands | Orilissa |
|---|---|
| Drug Class | Gonadotropin-releasing hormone (GnRH) antagonist |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
More on Orilissa (elagolix) essentials
Side effects of Orilissa (elagolix)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
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%)
Less Common Side Effects
- Anxiety
- Joint pain
- Stomach pain
- Diarrhea
- Constipation
- Weight gain
- Dizziness
- Irritability (crankiness)
- Lower sex drive
Orilissa (elagolix) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: rash; swelling of your lips, tongue, or throat; trouble breathing
- Liver damage: yellowing of your skin or whites of your eyes, stomach pain, nausea, vomiting, loss of appetite, dark urine, tiredness
- New or worsening depression, anxiety, or other mood or behavior changes
- Suicidal thoughts or behavior
The following Orilissa (elagolix) 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
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Pros and cons of Orilissa (elagolix)
Pros
- Helps reduce pain due to endometriosis
- Doesn't contain hormones
- Taken once a day (or twice a day if you have pain during sex)
Cons
- Might not feel less pain right away (can take a month or longer)
- Taken for a set amount of time because of bone loss risk with long-term use
- Can cause hot flashes and change menstrual bleeding patterns
Pharmacist tips for Orilissa (elagolix)
- Before starting Orilissa (elagolix), your prescriber might check that you're not pregnant. Or, you might need to wait to start the medication within 7 days after your next menstrual period starts. This makes sure Orilissa (elagolix) is safe to start since it can harm an unborn baby.
- Take Orilissa (elagolix) at the same time(s) each day, with or without food.
- If you miss your Orilissa (elagolix) dose, take it as soon as you remember as long as it's on the same day as your missed dose. Don't double up on doses since this can raise your risk of side effects. Skip the missed dose if you remember more than a day later.
- Hot flashes are a common side effect of Orilissa (elagolix). If you have one, dress in layers, keep your room cool, and use a fan to help. Also avoid foods and drinks that might make it worse, like spicy foods and hot drinks. Tell your care team if hot flashes bother you too much or make it hard to go about your daily activities.
- You might notice changes in your menstrual bleeding patterns while taking Orilissa (elagolix). Your periods might be lighter, less intense, or shorter than usual. Or, you might not always have a period. Because of this, it might be harder to tell if you become pregnant. If you think you might be pregnant, take a pregnancy test.
- Talk to your prescriber about how much alcohol you usually drink and how much is safe to drink with Orilissa (elagolix). There isn't a known interaction between the two. But alcohol can make side effects like hot flashes, nausea, and headache worse.
- Tell your care team if you notice any new or worsening depression, anxiety, or other changes in your mood or behavior during treatment. Orilissa (elagolix) can cause mood changes in some people.
- Ask your prescriber about taking a calcium and vitamin D supplement during treatment. Orilissa (elagolix) can raise your risk of bone loss with higher doses and longer treatment. These supplements can be helpful for keeping your bones strong.
- If you can become pregnant: Use non-hormonal birth control while taking Orilissa (elagolix) if you're sexually active. This can include condoms or Paragard (the copper intrauterine device). Keep using this method for 28 days after stopping Orilissa (elagolix). This medication can interact with hormonal birth control. It can also be harmful to a pregnancy.
- If you get pregnant while taking Orilissa (elagolix): Stop taking the medication right away and tell your prescriber. Orilissa (elagolix) can raise the risk of miscarriage during early pregnancy.
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 time | Taking a higher dose of Orilissa (elagolix)
Orilissa (elagolix) can lower your bone mineral density (BMD). This means that it might make your bones weaker. The risk might be higher the longer you take it and at higher doses. Some bone loss might not completely reversible after you stop the medication. It's not clear how this might affect your long-term bone health and your risk of breaking a bone.
If you have osteoporosis, tell your prescriber before starting Orilissa (elagolix). This medication isn't recommended because of the risk of bone loss.
If you take Orilissa (elagolix), there's a limit to how long you can take it. Depending on your situation, treatment is usually up to 6 months or 2 years. Your prescriber might also have you take calcium and vitamin D supplements to support bone health.
Change in menstrual bleeding pattern and effect on recognizing pregnancy
People who take Orilissa (elagolix) might have lighter, less intense, or shorter monthly menstrual periods. These changes can make it harder to tell if you're pregnant.
If you're been sexually active and think you might be pregnant, take a pregnancy test. If the test says you're pregnant, stop taking Orilissa (elagolix) right away and tell your prescriber. This medication might raise the risk of 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 and mood changes. Some people have also had suicidal thoughts or behavior.
Tell your care team right away if you or your loved ones notice new or worsening depression, anxiety, or other unusual changes in your mood or behavior while taking Orilissa (elagolix). Your prescriber can decide if you should keep taking it and if you should speak with a mental health professional.
Call 911 as soon as possible if you have thoughts of hurting yourself. You can also call or text 988 to reach the Suicide & Crisis Lifeline.
Liver damage
- Risk factors: Liver problems | Higher dose of Orilissa (elagolix)
In studies, some people taking Orilissa (elagolix) had higher liver enzyme levels. This can sometimes be a sign of liver damage.
To help lower your risk, your prescriber will make sure you're taking the lowest dose of the medication that works for you. Get medical help right away if you notice any signs of liver damage. This can include yellowing of your skin or whites of your eyes, nausea, stomach pain, or loss of appetite. Your care team will check your liver with blood tests to see if you should keep taking Orilissa (elagolix).
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, such as birth control pills, patches, or rings. It might raise the risk of side effects from the estrogen in these birth control methods. The estrogen might also make Orilissa (elagolix) work less well. And, the birth control itself might not work as well and raise your risk of getting pregnant. It's not clear how Orilissa (elagolix) affects progestin-only birth control.
To help prevent pregnancy, use a non-hormonal birth control method while taking Orilissa (elagolix). Examples include condoms or Paragard (the copper intrauterine device). Talk with your prescriber about the best birth control option for you.
Risk of harm to an unborn baby
Orilissa (elagolix) might raise the risk of pregnancy loss if taken early in pregnancy. If you can become pregnant, your prescriber might ask you to take a pregnancy test before starting treatment. Use effective non-hormonal birth control while taking this medication. Keep using this birth control for 28 days after your last dose. If you become pregnant during treatment, stop taking Orilissa (elagolix) right away and call your prescriber.
Orilissa (elagolix) dosage
How much does Orilissa (elagolix) cost?
$1,232.38
Orilissa (elagolix) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Orilissa (elagolix) will not be safe for you to take.
- Currently pregnant
- Osteoporosis
- Severe liver problems
- Take certain medications that raise the levels of Orilissa (elagolix) in the body
What are alternatives to Orilissa (elagolix)?
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