Myfembree® (relugolix, estradiol, and norethindrone acetate) tablets 40 mg, 1 mg, 0.5 mg

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Break the cycle of heavy periods from uterine fibroids

If you're tired of excessive bleeding, you aren't alone. Many women struggle with heavy periods from uterine fibroids (UF) every month.

The good news? Significant relief is possible with Myfembree.

What is Myfembree?

Photo of the Pill
The first and only FDA-approved once-daily pill proven to notably reduce heavy periods from UF in premenopausal women.
One small (8 mm in diameter) prescription pill taken once a day.
It's not a surgery, procedure, or injection.

What are the benefits of Myfembree?

Myfembree was studied and proven effective in two 6-month clinical studies in a total of 768 premenopausal women who had heavy period bleeding due to UF.

By week 24, average period bleeding went down by 84%—nearly 5x more than placebo.*

7 out of 10 women†saw their bleeding drop by at least half and to a normal level‡ or less by the last month of treatment.

On average, before starting the study, women had bleeding 3 times the normal amount of a typical period.‡

*Compared with an average 17% reduction of blood loss in the placebo group. †Compared with 16% of women in the placebo group.‡Normal bleeding is defined as 80 mL (about 1/3 cup) or less.

What you could expect

when taking Myfembree

For heavy periods from uterine fibroids
Your next period could be lighter. While the studies were not specifically designed to determine how quickly Myfembree worked, some of the women started to see a reduction in bleeding at week 4.
50% of women stopped getting their periods during the last month of treatmentin the studies.§ A majority of women saw their periods return once they stopped the therapy,‖ typically within 1-2 months.
On average, 1 in 2 women with low hemoglobin saw an increase in their levels by week 24.#

§Compared with 5% of women taking placebo.

‖Based on 65 women who did not enter a post-treatment extension study or stopped treatment earlier.

With Myfembree, 49% of women with low hemoglobin levels at the start of the studies saw levels rise by at least 2 g/dL by week 24, vs 10% on placebo.

#Myfembree was not specifically studied in women with anemia. Hemoglobin levels in the blood at 10.5 g/dL or less may be a sign of anemia. The normal levels of hemoglobin for women are above 12 g/dL.

Understanding Possible Side Effects

In clinical trials, the safety of Myfembree was also studied.

The most common side effects

The most common side effects of taking Myfembree for heavy period bleeding due to UF include hot flushes, increased sweating, night sweats, abnormal vaginal bleeding (bleeding that lasts too long, is too heavy, or is unexpected), hair loss or hair thinning, and decreased interest in sex. Always tell your doctor if you experience a side effect that bothers you or will not go away.

Serious side effects

Serious side effects were reported in 3.1% of women on Myfembree vs 2.3% on placebo. Fibroid expulsion with heavy bleeding, fibroid prolapse, gallbladder inflammation, and pelvic pain were experienced by one person each across both studies.

Discontinuations

In clinical trials, 3.9% of women treated with Myfembree stopped taking Myfembree as a result of side effects, compared to 4.3% of women in the placebo group. The most common side effect that led to discontinuation was uterine bleeding (1.2%), occurring usually within the first 3 months of treatment.

These are not all the possible side effects of Myfembree.

Ready to talk to your doctor about Myfembree?

How does Myfembree work?

Myfembree is made of 3 key ingredients, designed to support an optimal hormone range that promotes the reduction of heavy bleeding from fibroids.

Relugolix

Relugolix may reduce the amount of estrogen (and other hormones) in your body to help reduce menstrual bleeding.

Estradiol (an estrogen)

Estradiol may reduce the risk of bone loss that may be caused by taking relugolix alone.

Norethindrone acetate (a progestin)

Norethindrone acetate may protect the uterus from the effect of taking estrogen alone.

There are ways to potentially save on the cost of Myfembree.

USE

Myfembree is used in premenopausal women ≥18 years of age to:
  • control heavy menstrual bleeding due to uterine fibroids or
  • manage moderate to severe pain associated with endometriosis

It should not be taken for more than 24 months.

IMPORTANT SAFETY INFORMATION

Boxed Warning. Cardiovascular conditions: Myfembree may increase your chances of heart attack, stroke, or blood clots, especially if you are >35 years old and smoke or have uncontrolled high blood pressure. Stop taking Myfembree and call your healthcare provider (HCP) or go to the nearest emergency room right away if you have:leg pain or swelling that won’t go away; sudden shortness of breath; double vision, bulging of the eyes, sudden partial or complete blindness; 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.

Do not take Myfembree if you:
  • have or have had blood clots in your legs, lungs, or eyes; a stroke or heart attack; a problem that makes your blood clot more than normal; blood circulation disorders; certain heart valve or rhythm problems 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 >35 years old; breast cancer or any cancer that is sensitive to female hormones; osteoporosis; undiagnosed vaginal bleeding; liver problems;
  • smoke and are >35 years old;
  • have had a serious allergic reaction (e.g., 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 in Myfembree.

Bone loss (decreased bone mineral density [BMD]).While taking Myfembree, your estrogen levels may be low, which can lead to BMD loss. If this happens, your BMD may improve after you stop Myfembree, but complete recovery may not occur. It is unknown if these BMD 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 HCP may order an X-ray test called a DXA scan to check your BMD when you start Myfembree and periodically after you start if you have uterine fibroids or annually if you have pain associated with endometriosis.

Suicidal thoughts and behavior and worsening of mood. Call your HCP 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 or 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 HCP right away if you have any of these signs and symptoms of liver problems: jaundice, dark, amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, bruising easily.

High blood pressure.See your HCP to check your blood pressure regularly.

Effects on pregnancy. Do not take Myfembree if you are trying to become or are pregnant. It may increase the risk of early pregnancy loss. If you think you are pregnant, stop taking Myfembree right away and call your HCP. Myfembree can cause decreased or no menstrual bleeding, making it hard to know if you are pregnant. Watch for other signs of pregnancy like breast tenderness, weight gain, and nausea. Myfembree does not prevent pregnancy. You will need to use effective non-hormonal methods of birth control (e.g., condoms, spermicide) during and for 1 week after stopping Myfembree. Do not take hormonal birth control such as birth control pills, because they may increase side effects and Myfembree may not work as well.

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

Severe allergic reactions.Myfembree may cause swelling of your face, lips, mouth or tongue, trouble breathing, skin rashes, and redness.

Most common side effects in heavy menstrual bleeding with uterine fibroidsare hot flushes, increased sweating, night sweats, abnormal vaginal bleeding, hair loss or thinning, and decreased interest in sex.

Most common side effects in moderate to severe pain with endometriosisare headache, hot flushes/sweating/night sweats, mood changes including worsening depression, abnormal vaginal bleeding, nausea, toothache, back pain, decreased interest in sex, joint pain, tiredness, and dizziness.

These are not all the possible side effects of Myfembree. Call your doctor for medical advice about side effects.

Tell your HCP about all yourprescription and over-the-counter medicines, vitamins, and herbal supplements. If you take oral P-gp inhibitors, take Myfembree first and wait at least 6 hours before taking the P-gp inhibitor. Ask your HCP if you are not sure if you are taking this type of medicine.

Tell your HCP if you are breastfeeding.Myfembree may pass into your breast milk.

Please see full Prescribing Information, including BOXED WARNING and Patient Information

 

IMPORTANT SAFETY INFORMATION

Boxed Warning. Cardiovascular conditions: Myfembree may increase your chances of heart attack, stroke, or blood clots, especially if you are >35 years old and smoke or have uncontrolled high blood pressure. Stop taking Myfembree and call your healthcare provider (HCP) or go to the nearest emergency room right away if you have:leg pain or swelling that won’t go away; sudden shortness of breath; double vision, bulging of the eyes, sudden partial or complete blindness; 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.

Do not take Myfembree if you:
  • have or have had blood clots in your legs, lungs, or eyes; a stroke or heart attack; a problem that makes your blood clot more than normal; blood circulation disorders; certain heart valve or rhythm problems 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 >35 years old; breast cancer or any cancer that is sensitive to female hormones; osteoporosis; undiagnosed vaginal bleeding; liver problems;
  • smoke and are >35 years old;
  • have had a serious allergic reaction (e.g., 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 in Myfembree.

Bone loss (decreased bone mineral density [BMD]).While taking Myfembree, your estrogen levels may be low, which can lead to BMD loss. If this happens, your BMD may improve after you stop Myfembree, but complete recovery may not occur. It is unknown if these BMD 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 HCP may order an X-ray test called a DXA scan to check your BMD when you start Myfembree and periodically after you start if you have uterine fibroids or annually if you have pain associated with endometriosis.

Suicidal thoughts and behavior and worsening of mood. Call your HCP 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 or 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 HCP right away if you have any of these signs and symptoms of liver problems: jaundice, dark, amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, bruising easily.

High blood pressure.See your HCP to check your blood pressure regularly.

Effects on pregnancy. Do not take Myfembree if you are trying to become or are pregnant. It may increase the risk of early pregnancy loss. If you think you are pregnant, stop taking Myfembree right away and call your HCP. Myfembree can cause decreased or no menstrual bleeding, making it hard to know if you are pregnant. Watch for other signs of pregnancy like breast tenderness, weight gain, and nausea. Myfembree does not prevent pregnancy. You will need to use effective non-hormonal methods of birth control (e.g., condoms, spermicide) during and for 1 week after stopping Myfembree. Do not take hormonal birth control such as birth control pills, because they may increase side effects and Myfembree may not work as well.

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

Severe allergic reactions.Myfembree may cause swelling of your face, lips, mouth or tongue, trouble breathing, skin rashes, and redness.

Most common side effects in heavy menstrual bleeding with uterine fibroidsare hot flushes, increased sweating, night sweats, abnormal vaginal bleeding, hair loss or thinning, and decreased interest in sex.

Most common side effects in moderate to severe pain with endometriosisare headache, hot flushes/sweating/night sweats, mood changes including worsening depression, abnormal vaginal bleeding, nausea, toothache, back pain, decreased interest in sex, joint pain, tiredness, and dizziness.

These are not all the possible side effects of Myfembree. Call your doctor for medical advice about side effects.

Tell your HCP about all yourprescription and over-the-counter medicines, vitamins, and herbal supplements. If you take oral P-gp inhibitors, take Myfembree first and wait at least 6 hours before taking the P-gp inhibitor. Ask your HCP if you are not sure if you are taking this type of medicine.

Tell your HCP if you are breastfeeding.Myfembree may pass into your breast milk.

Please see full Prescribing Information, including BOXED WARNING and Patient Information

Myfembree® (relugolix, estradiol, and norethindrone acetate) tablets 40 mg, 1 mg, 0.5 mg

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