Elagolix/Estradiol/Norethindrone Oral Capsule and Elagolix Oral Capsule (ELAGOLIX/ESTRADIOL/NORETHINDRONE AND 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 away from heat, light, and moisture. Do not keep in the bathroom.

This medicine may cause dark patches to appear on your face. Avoid sunlight and use sunscreen lotion to minimize further darkening of these skin patches.

Avoid grapefruit and grapefruit juice while on this medicine.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it if you remember within 4 hours of the scheduled dose. If you don’t remember until after more than 4 hours, skip the missed dose and return to your regular schedule with the next dose. Do not take 2 doses of this medicine 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.

Cautions

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

This medicine is associated with an increased risk of blood clots, heart attack, and stroke. Contact your doctor immediately if you experience leg pain or swelling, difficulty breathing, chest or jaw pain, severe headache, one-sided weakness or slurred speech.

Do not use the medication any more than instructed.

Avoid smoking while on this medicine. Smoking may increase your risk for stroke, heart attack, blood clots, high blood pressure, and other diseases of the heart and blood vessels.

This medicine passes into breast milk. Ask your doctor before 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 using this medicine and for 28 days 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.

• lack of energy and tiredness
• feeling of heat or flushing
• hair loss
• headaches
• high blood pressure
• menstruation changes (missed or fewer periods)

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

• bone pain
• breast lumps
• chest or jaw pain
• depression or feeling sad
• dizziness
• fainting
• high blood sugar
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• mood changes
• shortness of breath
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• suicidal thoughts
• excessive or unusual sweating
• persistent or unusual thirst
• increased urinary frequency
• vaginal bleeding or spotting between periods

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.