Generic Name: elagolix
Dosage Form: Tablets
Date of Approval: July 23, 2018
Company: AbbVie Inc.
Treatment for: Endometriosis
Medically reviewed on July 31, 2018
FDA Approves Orilissa
The U.S. Food and Drug Administration (FDA) has approved Orilissa (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist for the treatment of women with moderate to severe endometriosis pain.
Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Orilissa may cause serious side effects, including:
- bone loss (decreased bone mineral density).
- While you are taking Orilissa, your estrogen levels will be low. Low estrogen levels can lead to bone mineral density loss.
- Your bone density may improve after you stop taking Orilissa but complete recovery may not occur. It is unknown if these bone changes could increase your risk for broken bones as you age.
- Your healthcare provider may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle that promotes bone health.
- If you have conditions or take other medicines that can cause bone loss, or if you have broken a bone with minimal or no injury, your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density.
- effects on pregnancy
- Do not take Orilissa if you are trying to become or are pregnant. It may increase the risk of early pregnancy loss.
- If you think you are pregnant, stop taking Orilissa right away and call your healthcare provider.
- Orilissa may change your menstrual periods (irregular bleeding or spotting, a decrease in menstrual bleeding, or no bleeding at all), making it hard to know if you are pregnant. Watch for other signs of pregnancy such as breast tenderness, weight gain and nausea.
- Orilissa does not prevent pregnancy. You will need to use effective methods of birth control that do not contain hormones such as condoms or spermicide while taking Orilissa and for one week after you stop taking Orilissa. Birth control pills that contain estrogen may make Orilissa less effective. It is not known how well Orilissa will work while you are taking progestin-only birth control such as injections or implants.
- Talk to your healthcare provider about which birth control to use during treatment. Your healthcare provider may change the birth control you were on before you start treatment.
What is Orilissa?
Orilissa is a prescription medicine used to treat moderate to severe pain associated with endometriosis.
It is not known if this medicine is safe and effective in children under 18 years of age.
Who should not take Orilissa?
You should not take Orilissa if you:
- are or may be pregnant
- have osteoporosis
- have severe liver disease
- are taking medicines known as strong OATP1B1 inhibitors such as cyclosporine or gemfibrozil. Ask your healthcare provider if you are not sure if you are taking one of these medicines.
Before you take Orilissa
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had broken bones
- have other conditions or take medicines that may cause bone problems
- have or have had depression, mood problems or suicidal thoughts or behavior
- have liver problems
- think you may be pregnant. You should avoid becoming pregnant while taking Orilissa
- are breastfeeding or plan to breastfeed. It is not known if Orilissa passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take Orilissa.
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take:
- birth control pills. Your healthcare provider may advise you to change the pills you take, or your method of birth control.
Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take Orilissa?
- Take Orilissa exactly as your healthcare provider tells you to take it.
- Your healthcare provider will give you a pregnancy test before you start treatment or will have you start treatment within seven days after you start your period.
- If your healthcare provider prescribes:
- 150 mg (a pink tablet), take it one time each day
- 200 mg (an orange tablet), take it two times each day
- Take the tablets at about the same time each day with or without food.
- If you miss a dose:
- 150 mg (1 time each day), take it as soon as you remember as long as it is on the same day. Do not take more than 1 tablet each day.
- 200 mg (2 times each day), take it as soon as you remember as long as it is on the same day. Do not take more than 2 tablets each day.
- If you take too much or overdose, call your healthcare provider or go to the nearest hospital.
Orilissa side effects
Orilissa can cause serious side effects including:
- See Important information
- suicidal thoughts, suicidal behavior, and worsening of mood. Orilissa may cause suicidal thoughts or actions. Call your healthcare provider right away if you have any of these symptoms or call 911 if an emergency, especially if they are new, worse, or bother you:
- thoughts about suicide or dying
- try to commit suicide
- new or worse depression
- new or worse anxiety
- other unusual changes in behavior or mood
- abnormal liver tests. Call your healthcare provider right away if you have any of these signs and symptoms of liver problems:
- yellowing of the skin or the whites of the eyes (jaundice)
- dark amber-colored urine
- feeling tired (fatigue or exhaustion)
- nausea and vomiting
- generalized swelling
- right upper stomach area (abdomen) pain
- bruising easily
The most common side effects include: hot flashes or night sweats, headache, nausea, difficulty sleeping, absence of periods, anxiety, joint pain, depression and mood changes.
These are not all the possible side effects of Orilissa. Call your healthcare provider for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store Orilissa?
- Store Orilissa between 36°F to 86°F (2°C to 30°C).
- Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place in an unrecognizable closed container in the household trash. Do NOT flush Orilissa down the toilet. See www.fda.gov/drugdisposal for more information.
- Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Orilissa.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients in Orilissa?
Active ingredient: elagolix
- 150 mg tablets: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint.
- 200 mg tablets: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.