Treats heavy menstrual bleeding caused by uterine fibroids.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Capsule, Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take the morning and evening capsules at about the same time each day.
• Use this medicine within 7 days from the start of your menstrual period.
• You may receive other medicines (including calcium or vitamin D supplements) to help reduce bone loss.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and it is more than 4 hours from your normal dose, skip the missed dose and go back to your regular dosing schedule. If you miss a dose and it is within than 4 hours of your normal dose, take it as soon possible and go back to your regular dosing schedule. Do not take 2 doses to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with medicines called OATP 1B1 inhibitors that may increase elagolix levels in the blood. Your doctor should give you a list of these medicines.
• Some foods and medicines can affect how elagolix/estradiol/norethindrone works. Tell your doctor if you are using any of the following:
  • Digoxin, ketoconazole, midazolam, omeprazole, rifampin, rosuvastatin
  • Medicine to treat seizures
  • Oral or inhaled steroid medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms or spermicide) during treatment and for at least 28 days after the last dose.
• Tell your doctor if you are breastfeeding, or if you have blood vessel disease, high cholesterol, diabetes, mental problems, gallbladder problems, jaundice (yellow skin or eyes) caused by pregnancy or birth control pills, or a history of fractures. Tell your doctor if you smoke or if you will be having a surgery.
• This medicine may cause the following problems:
  • Increased risk of blood clots, heart attack, or stroke
  • Lower bone mineral density
  • Increased risk of breast cancer
  • Changes in mood or behavior, including thoughts of suicide
  • Liver problems
  • High blood pressure
  • Gallbladder disease
  • Changes in menstrual bleeding, which may decrease the ability to know if you are pregnant
  • High cholesterol and blood sugar
  • Hair loss
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
• Make sure any doctor or dentist who treats you knows that you are using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone pain, decreased height
• Breast lumps, pain, swelling, tenderness, or discharge
• Chest pain or tightness, trouble breathing, coughing up blood
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Dry mouth, increased hunger, thirst, or urination
• Extreme energy or restlessness, confusion, agitation, unusual mood or behavior, thoughts or attempts at killing oneself
• Light, heavy, or irregular bleeding during monthly periods
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Feeling of warmth, redness of the skin
• Thinning or loss of hair

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088