estradiol, norethindrone, and relugolix

What is the most important information I should know about this medicine?

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

What is estradiol, norethindrone, and relugolix (Myfembree)?

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

Myfembree may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Myfembree?

• 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.

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.

How should I take Myfembree?

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.

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

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

What happens if I miss a dose?

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

What happens if I overdose?

Overdose may cause nausea, vomiting, breast tenderness, and stomach pain.

What should I avoid while taking Myfembree?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of Myfembree?

• 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 have concerns about this side effect.

Common side effects 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 FDA at 1-800-FDA-1088.

What other drugs will affect Myfembree?

Some drugs can affect your blood levels of other drugs you take, which may increase 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.

Where can I get more information?

Your pharmacist can provide more information about Myfembree (estradiol, norethindrone, and relugolix).