Myfembree

Generic name: Relugolix, Estradiol And Norethindrone Acetate
Dosage form: tablets
Drug class: Sex hormone combinations

Usage of Myfembree

Myfembree is a prescription medicine used in premenopausal women (before “change of life” or menopause) to control heavy menstrual bleeding due to uterine fibroids.

Myfembree is also used in premenopausal women to manage moderate to severe pain associated with endometriosis.

Myfembree contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

It is not known if this medicine is safe and effective in children under 18 years of age.

Myfembree side effects

Myfembree may cause serious side effects including:

See Important information.

Suicidal thoughts, suicidal behavior, and worsening of mood. Call your healthcare provider or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you:

thoughts about suicide or dying

attempts to commit suicide

new or worse depression

new or worse anxiety

other unusual changes in behavior or mood

Pay attention to any changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.

Abnormal liver tests. Call your healthcare provider right away if you have any of these signs and symptoms of liver problems:

jaundice

dark amber-colored urine

feeling tired (fatigue or exhaustion)

nausea and vomiting

generalized swelling

right upper stomach area (abdomen) pain

bruising easily

Gallbladder problems (cholestasis), especially if you had cholestasis of pregnancy.

High blood pressure. See your healthcare provider to check your blood pressure regularly.

Uterine fibroid prolapse or expulsion. Fibroids can come out completely or partially through the vagina. Call your healthcare provider right away if you have increased bleeding from the vagina, which can be serious, or cramping, while taking Myfembree.

Hair loss (alopecia). Hair loss and hair thinning can happen while taking Myfembree. It is not known if this hair loss or hair thinning stops after you stop treatment, or is reversible. Talk to your healthcare provider if this is a concern for you.

Increases in the blood sugar, cholesterol and fat (triglycerides) levels in your blood.

Changes in laboratory tests including thyroid, steroid, hormone, cholesterol, and blood clotting tests.

The most common side effects in women who have heavy bleeding with uterine fibroids include:

hot flushes

increased sweating

night sweats

abnormal vaginal bleeding (bleeding that lasts too long, is too much, or is unexpected)

hair loss or hair thinning

decreased interest in sex

The most common side effects in women in women who have moderate to severe pain with endometriosis include:

headache

hot flushes, sweating, or night sweats

mood changes including worsening depression

abnormal vaginal bleeding (bleeding that lasts too long, that is too much, or is unexpected)

nausea

toothache

back pain

decreased interest in sex

joint pain

tiredness

dizziness

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800 FDA-1088.

Before taking Myfembree

You should not take Myfembree if you have or have had:

blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)

stroke or heart attack

a problem that makes your blood clot more than normal

blood circulation disorders

certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart

high blood pressure not well controlled by medicine

diabetes with kidney, eye, nerve, or blood vessel damage

certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision or migraine headaches if you are over age 35

breast cancer or any cancer that is sensitive to female hormones

osteoporosis

vaginal bleeding that has not been diagnosed. Your healthcare provider should check any unexplained vaginal bleeding to find out the cause.

liver problems including liver disease.

You should not take Myfembree if you:

smoke and are over 35 years old

have had a serious allergic reaction with symptoms that included swelling of your face, lips, mouth or tongue, trouble breathing, skin rashes, redness, or swelling or an allergic reaction to relugolix, estradiol, norethindrone or any of the ingredients. See the end of this page for a complete list of ingredients.

Relate drugs

How to use Myfembree

Usual Adult Dose for Uterine Fibroids

- One tablet orally once daily. Each tablet contains relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg.

Use: management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Usual Adult Dose for Endometriosis

- One tablet orally once daily. Each tablet contains relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg.

Use: management of moderate to severe pain associated with endometriosis in premenopausal women.

Warnings

Myfembree may cause serious side effects, including:

Cardiovascular conditions: Myfembree may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age, smoke, and have uncontrolled high blood pressure. Stop treatment and call your healthcare provider right away or go to the nearest hospital emergency room right away if you have:

leg pain or swelling that will not go away

sudden shortness of breath

double vision, bulging of the eyes, sudden blindness, partial or complete

pain or pressure in your chest, arm, or jaw

sudden, severe headache unlike your usual headaches

weakness or numbness in an arm or leg, or trouble speaking

Bone loss (decreased bone mineral density): While you are taking Myfembree, your estrogen levels may be low. Low estrogen levels can lead to bone mineral density loss.

If you have bone loss on Myfembree, your bone density may improve after you stop taking Myfembree, but complete recovery may not occur. It is unknown if these bone changes could increase your risk for broken bones as you age. For this reason, you should not take Myfembree for more than 24 months.

Your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density when you start treatment and periodically after you start.

Your healthcare provider may advise you to take vitamin D and/or calcium supplements as part of a healthy lifestyle that promotes bone health. If you are also advised to take iron supplements, they should be taken at least two hours apart from your vitamin D or calcium supplements.

Effects on pregnancy: Do not take Myfembree if you are trying to become pregnant or are pregnant. It may increase the risk of early pregnancy loss.

If you think you are pregnant, stop treatment right away and call your healthcare provider. If you become pregnant during treatment, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-(855) 428-0707.

Myfembree can decrease your menstrual bleeding or result in no menstrual bleeding at all, making it hard to know if you are pregnant. Watch for other signs of pregnancy such as breast tenderness, weight gain and nausea.

Myfembree does not prevent pregnancy. You will need to use effective methods of birth control during treatment and for 1 week after you stop treatment. Examples of effective methods can include condoms or spermicide, which do not contain hormones.

Do not take hormonal birth control such as birth control pills, because they may increase your side effects and Myfembree may not work as well.

Talk to your healthcare provider about which birth control to use during treatment. Your healthcare provider may change the birth control you were on before you start treatment.

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 interact with relugolix, estradiol , or norethindrone. 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.

Disclaimer

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