Elagolix Oral Tablet (ELAGOLIX - ORAL)

Instructions

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature or in the refrigerator. Do not freeze.

Keep the medicine away from heat and light.

If this is the first time that you are using this medicine, please speak with your doctor about when you should start this medicine.

If you forget to take a dose on time, take it as soon as you remember if it is on the same day. If you don’t remember until the next day, skip the missed dose and return to your regular schedule with the next dose. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Hormone birth control may make this medicine work less well. Women of childbearing age should talk with their doctor or pharmacist about reliable forms of non-hormonal birth control.

This medicine may affect the strength of your bones. If you have or are at increased risk for osteoporosis (weakening of the bones), your doctor may recommend foods with calcium and vitamin D.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than twice during 24 hours.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 1 week after stopping to prevent pregnancy.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• agitated feeling or trouble sleeping
• increased risk for bone fractures
• feeling of heat or flushing
• headaches
• menstruation changes (missed or fewer periods)
• nausea
• sweating at night

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• change in behavior
• bone pain
• changes in memory, mood, or thinking
• depression or feeling sad
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• mood changes
• suicidal thoughts

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.