Elagolix belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) receptor antagonist. It is an oral tablet used to help treat pain caused by endometriosis.

Endometriosis is a condition where tissue that should line the uterus or womb, grows outside of the uterus forming lesions. It affects about 1 in 10 women of reproductive age.

During your menstrual cycle these lesions grow in response to rising levels of a hormone called estrogen, then they break down and shed during your period. This can cause pain throughout your cycle.

Elagolix helps to reduce the pain you experience by reducing the amount of estrogen you produce that encourages the lesions to grow. Elagolix works by binding to GnRH receptors in the pituitary gland, which suppresses luteinizing hormone (LH) and follicle-stimulating hormone (FSH) and leads to a decrease in estrogen.

What is elagolix used for?

Elagolix is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if elagolix is safe and effective in children.

Elagolix may cause serious side effects, including:

• bone loss (decreased bone mineral density).
  • While you are taking elagolix, your estrogen levels will be low. Low estrogen levels can lead to bone mineral density loss.
  • If you have bone loss on elagolix, your bone density may improve after you stop taking elagolix but complete recovery may not occur. It is unknown if these bone changes could increase your risk for broken bones as you age. For this reason, your healthcare provider may limit the length of time you take elagolix.
  • 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 elagolix 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 elagolix right away and call your healthcare provider.
  • If you become pregnant while taking elagolix, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-833-782-7241 to enroll in this registry.
  • elagolix 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.
  • elagolix does not prevent pregnancy. You will need to use effective methods of birth control while taking elagolix and for 28 days after you stop taking elagolix. Examples of effective methods can include condoms or spermicide, which do not contain hormones.
  • Birth control pills that contain estrogen may make elagolix less effective. It is not known how well elagolix 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 with elagolix. Your healthcare provider may change the birth control you were on before you start taking elagolix.

• Take elagolix exactly as your healthcare provider tells you to take it.
• Your healthcare provider will give you a pregnancy test before you start taking elagolix or will have you start taking elagolix within 7 days after you start your period.
• If your healthcare provider prescribes:
  • Elagolix 150 mg (a pink tablet), take it 1 time each day
  • Elagolix 200 mg (an orange tablet), take it 2 times each day
• Take elagolix at about the same time each day with or without food.

Two dosing regimens are available:

• Elagolix 150mg once daily for up to 24 months
• Elagolix 200mg twice daily for up to 6 months
• See Full Prescribing Information for further details.

Do not take elagolix if you:

• are pregnant
• have osteoporosis
• have severe liver disease
• are taking medicines called organic anion transporting polypeptide (OATP)1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix. Ask your healthcare provider if you are not sure if you are taking one of these medicines.
• have had a serious allergic reaction to elagolix or any of the other ingredients in the medication. See below for a complete list of ingredients in elagolix. Ask your healthcare provider if you are not sure.

What should I tell my doctor before taking elagolix?

Before you take elagolix, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had broken bones or other conditions that may cause bone problems
• have or have had depression, mood problems or suicidal thoughts or behavior
• have liver problems

If you miss a dose of elagolix:

• 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 elagolix, call your healthcare provider or go to the nearest hospital emergency room right away.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature or in the refrigerator (2–30°C) and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Elagolix can cause serious side effects including:

• See “Important information”
• suicidal thoughts, suicidal behavior, and worsening of mood. elagolix may cause suicidal thoughts or actions. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or bother you:
  • thoughts about suicide or dying
  • attempts 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

You or your caregiver should pay attention to any changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.

The most common side effects of elagolix include: hot flashes and 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 elagolix. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• birth control that contains hormones. Your healthcare provider may advise you to change 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.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before and during your treatment to check your body's response to elagolix.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.