Estradiol, norethindrone, and relugolix

Estradiol, norethindrone, and relugolix (Myfembree) is used to manage heavy menstrual bleeding caused by uterine fibroids in premenopausal women.

Myfembree may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Myfembree is usually taken as soon as possible after the start of a menstrual period, but no later than 7 days after the period has started.

Take the medicine at the same time each day, with or without food.

Your period may be heavy or irregular for the first month, but bleeding should then decrease.

Your doctor may also want you to take calcium and vitamin D supplements, or an iron supplement. Avoid iron within 2 hours before or after you take calcium or vitamin D.

You may need an occasional bone x-ray called a DXA scan to check your bone mineral density.

Myfembree can affect the results of certain medical tests. Tell any doctor who treats you that you are using estradiol, norethindrone, and relugolix.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Myfembree.

You should not take this medicine for longer than 24 months.

Store at room temperature away from moisture and heat.

Do not keep leftover Myfembree. Ask your pharmacist about a drug take-back program. Do not flush the unused medicine down the toilet.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are at an even higher risk if you are over 35 years old, smoke, and have uncontrolled high blood pressure.

Smoking can significantly raise your risk of blood clots, stroke, or heart attack. You should not use this medicine if you smoke and are older than 35 years old.

Stop taking this medicine and seek medical help immediately if you experience signs of a heart attack or stroke: chest pain, sudden numbness or weakness, slurred speech, severe headache, vision problems, leg pain or swelling, or difficulty breathing.

You should not use Myfembree if you are allergic to estradiol, norethindrone, or relugolix, or if you have:

• untreated or uncontrolled high blood pressure;
• heart problems (heart valve disorder or heart rhythm disorder);
• a history of heart attack, stroke, or blood clot;
• blood circulation problems;
• an increased risk of having blood clots due to a hereditary blood disorder;
• diabetes with damage to your kidneys, eyes, nerves, or blood vessels;
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• osteoporosis; or
• liver disease.

Tell your doctor if you have ever had:

• high blood pressure;
• high cholesterol or triglycerides;
• a broken bone or other bone problems;
• depression or a mood disorder;
• problems with your gallbladder, thyroid, or adrenal gland;
• suicidal thoughts or actions;
• jaundice caused by pregnancy; or
• if you are pregnant or recently had a baby.

You may need to have a negative pregnancy test before starting this treatment.

May cause a miscarriage. Do not use if you are pregnant. Stop using estradiol, norethindrone, and relugolix and tell your doctor if you become pregnant. Use birth control while using estradiol, norethindrone, and relugolix and for at least 1 week after your last dose.

To prevent pregnancy, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Hormonal birth control (birth control pills, injections, implants, skin patches, vaginal rings) can make Myfembree less effective or increase side effects.

It may be harder to tell you are pregnant because this medicine may decrease menstrual bleeding. Watch for other signs of pregnancy such as nausea, breast tenderness, and weight gain.

You should not breastfeed while using Myfembree.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking estradiol, norethindrone, and relugolix and get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, severe headache, vision problems, bulging eyes, leg pain or swelling, feeling short of breath.

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you have:

• increased or heavy vaginal bleeding or cramping;
• new or worsening anxiety, depression, or unusual changes in mood or behavior;
• thoughts about suicide; or
• liver problems--nausea, vomiting, stomach pain (upper right side), tiredness, bruising, dark urine, jaundice (yellowing of the skin or eyes).

May cause hair loss or thinning hair. Talk to your doctor if you are worried about this side effect.

Common side effects of estradiol, norethindrone, and relugolix may include:

• hot flashes, sweating;
• unusual vaginal bleeding; or
• decreased interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Endometriosis:

1 tablet orally once a dayTotal duration of therapy: 24 monthsComments:-Exclude pregnancy and discontinue hormonal contraceptives prior to use.-Start this drug as early as possible after onset of menses but no later than 7 days after menses has started.-Assess bone mineral density at baseline and then periodically or annually thereafter. -Limit duration due to potential risk of irreversible bone loss. Uses: -For the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women-For the management of moderate to severe pain associated with endometriosis in premenopausal women

Usual Adult Dose for Uterine Fibroids:

1 tablet orally once a dayTotal duration of therapy: 24 monthsComments:-Exclude pregnancy and discontinue hormonal contraceptives prior to use.-Start this drug as early as possible after onset of menses but no later than 7 days after menses has started.-Assess bone mineral density at baseline and then periodically or annually thereafter. -Limit duration due to potential risk of irreversible bone loss. Uses: -For the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women-For the management of moderate to severe pain associated with endometriosis in premenopausal women

Usual Adult Dose for Menstrual Disorders:

1 tablet orally once a dayTotal duration of therapy: 24 monthsComments:-Exclude pregnancy and discontinue hormonal contraceptives prior to use.-Start this drug as early as possible after onset of menses but no later than 7 days after menses has started.-Assess bone mineral density at baseline and then periodically or annually thereafter. -Limit duration due to potential risk of irreversible bone loss. Uses: -For the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women-For the management of moderate to severe pain associated with endometriosis in premenopausal women

Take the missed dose on the same day you remember it. Take your next dose at the regular time and continue with your once-daily schedule. Do not take 2 doses in one day.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

An overdose may lead to nausea, vomiting, breast tenderness, and stomach pain.

Follow your doctor's guidance regarding any limitations on food, drinks, or activities.

Some drugs can change the levels of other drugs in your blood, which may lead to more side effects or make the medications less effective.

Take your Myfembree dose 6 hours before taking other medications, especially:

• antibiotic or antifungal medicine (such as azithromycin, clarithromycin, erythromycin, itraconazole, or ketoconazole);
• antiviral medicine to treat HIV or hepatitis C;
• cancer medicine you take by mouth;
• heart medicine (such as amiodarone, carvedilol, captopril, dronedarone, propafenone, quinidine, ranolazine, ticagrelor, or verapamil);
• medicine for cystic fibrosis; or
• medicine to prevent organ transplant rejection.

This list is not complete, and many other drugs may affect Myfembree. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines. Not all possible drug interactions are listed here.