Relugolix; Estradiol; Norethindrone Tablets

What is this medication?

RELUGOLIX; ESTRADIOL; NORETHINDRONE (rel loo GOE lix; es tra DYE ole; nor eth IN drone) helps reduce heavy periods caused by uterine fibroids. It may also be used to treat pain from endometriosis. Relugolix works by decreasing the amount of estrogen and other hormones your body makes, which reduces heavy bleeding and pain. Estradiol lowers the risk of bone loss caused by relugolix. Norethindrone helps lower the risk of cancer that can be caused by estradiol. This medication contains the hormones estrogen and progestin.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Myfembree

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood clots
• Breast, cervical, endometrial, or uterine cancer
• Diabetes
• Gallbladder disease
• Heart disease
• High blood pressure
• High cholesterol
• Kidney disease
• Liver disease
• Lupus
• Mental health condition
• Migraine headaches
• Osteoporosis, weak bones
• Porphyria
• Stroke
• Suicidal thoughts, plans, or attempt by you or a family member
• Tobacco use
• Unexplained vaginal bleeding
• An unusual or allergic reaction to relugolix, estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Aromatase inhibitors, such as aminoglutethimide, anastrozole, exemestane, letrozole, testolactone
• Cisapride
• Dronedarone
• Elagolix
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Certain antibiotics, such as erythromycin, clarithromycin, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for cancer treatment
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Corticosteroids, such as hydrocortisone, prednisone, prednisolone
• Cyclosporine
• Grapefruit juice
• Medications for diabetes
• Mifepristone
• Other medications that cause heart rhythm changes
• Raloxifene
• Rifampin
• St. John's wort
• Tamoxifen
• Thyroid hormones
• Tranexamic acid
• Tricyclic antidepressants
• Verapamil
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam while on this medication. It may take several months to see improvement in your condition.

You may have a change in bleeding pattern, irregular periods, or may stop having periods while taking this medication.

Talk with your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 week after the last dose. Contraception is recommended while taking this medication and for 1 week after the last dose. Your care team can help you find the option that works for you.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while taking this medication. The risk is higher if you are over the age of 35.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Heavy vaginal bleeding
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Dizziness
• Fatigue
• Hair loss
• Headache
• Hot flashes

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.