PRESCRIBING INFORMATION
PATIENT INFORMATION
Heavy Periods From Uterine Fibroids
Myfembree® (relugolix, estradiol, and norethindrone acetate) tablets 40 mg, 1 mg, 0.5 mg

My doctor and I had a different conversation and it led us in a different direction.

Comparing your endo pain to barbed wire isn’t dramatic, it’s real.

It can be difficult to communicate your pain, but it’s important that your doctor listens to and understands the details of how endo pain impacts your daily activities.

Use these questions to help guide the conversation and inform your next treatment decision.

Woman cradling her belly experiencing endometriosis pain, wrapped in barbed wire to illustrate discomfort. Not an actual patient.
  1. I experience endometriosis pain
     
    Select all that apply
    Question 1 of 8
  2. When I have endo pain, it feels
     
    Question 2 of 8
  3. I have trouble with daily activities like walking, attending social events, exercising, or doing household chores because of my endo pain
     
    Question 3 of 8
  4. The pain I experience during sex is
     
    Question 4 of 8
  5. I was diagnosed with endo
     
    Question 5 of 8
  6. I use over-the-counter or prescription painkillers for my endo pain
     
    Question 6 of 8
  7. I feel like I’m not getting relief from my endo pain
     
    Question 7 of 8
  8. I would be interested in taking a once-daily pill for endo pain
     
    Question 8 of 8
  9. Thank you for your responses!
     
    Note any other concerns you have relating to your endometriosis pain and its impact on your daily activities ahead of your next appointment.
     
Item 1 of 9

Talking to your doctor about endometriosis pain

Thanks for taking a moment to answer these questions.

Here are your responses. Keep them handy for your next appointment to help
you have a productive conversation with your doctor.

  

USE

Myfembree is used to control heavy menstrual bleeding due to uterine fibroids in premenopausal women ≥ 18 years of age. 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.


Please see additional Important Safety Information on the following page

IMPORTANT SAFETY INFORMATION (continued)
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.
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.
Please see additional Important Safety Information on the following page
IMPORTANT SAFETY INFORMATION (continued)
Severe allergic reaction: Myfembree may cause swelling of your face, lips, mouth or tongue, trouble breathing, skin rashes, and redness.
Most common side effects are hot flushes, increased sweating, night sweats, abnormal vaginal bleeding, hair loss or thinning, and decreased interest in sex.
Tell your HCP about all your prescription 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, at MYFEMBREE.com

is a trademark of Sumitomo Pharma Co., Ltd., used under license.
SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license.
SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license.
Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co. Ltd.
MYFEMBREE® and its associated logo are registered trademarks of Sumitomo Pharma Switzerland GmbH.
© 2025 Sumitomo Pharma Switzerland GmbH. All rights reserved. MYF-US-0014-25 04/25
Relief from moderate to severe endometriosis pain is possible with 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 fibroids are 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 endometriosis are 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 your prescription 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