Estradiol (es-tra-DYE-ol), Norethindrone Acetate (nor-ETH-in-drone AS-e-tate), Relugolix (rel-ue-GOE-lix)

Treats heavy menstrual bleeding caused by uterine fibroids and pain caused by endometriosis.

Brand Name(s):

Myfembree

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take the tablet 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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine 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.

• Some medicines can affect how relugolix/estradiol/norethindrone works. Tell your doctor if you are using erythromycin or rifampin.
• Take this medicine at least 6 hours before taking other medicines called P-gp inhibitors. Ask your doctor about these medicines.

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. This medicine may increase your risk of early pregnancy loss. 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 1 week 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
  • Gallbladder disease
  • High blood pressure
  • Changes in menstrual bleeding, which may decrease the ability to know if you are pregnant
  • Hair loss
  • High cholesterol and blood sugar
• 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
• Rapid weight gain, swelling in your hands, ankles, or feet
• Stomach pain, nausea, vomiting, lightheadedness
• Sudden or severe headache, problems with vision, speech, or walking
• Thinning or loss of hair

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

• Back or joint pain
• Decreased interest in sex
• Dizziness, tiredness
• Feeling of warmth, redness of the skin, sweating
• Toothache

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