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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.
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 are hot flushes, increased sweating, night sweats,
abnormal vaginal bleeding, hair loss or thinning, and decreased interest in sex.
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.
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.
Please see full Prescribing Information, including BOXED WARNING and
Patient Information
Myfembree® and its associated logo are registered trademarks of Myovant Sciences
GmbH.
All other trademarks are the property of their respective owners.
©2023 Myovant Sciences GmbH and Pfizer Inc.
All rights reserved. PP-US-REL-CT-2300080 05/23