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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
