MYFEMBREE
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Manufactured by Sumitomo Pharma
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MYFEMBREE Uses, Side Effects, Interactions, Warnings & Dosing
What is MYFEMBREE?
MYFEMBREE is the brand name for relugolix, estradiol, and norethindrone acetate and is available as an oral tablet.
What dosages is MYFEMBREE available in?
MYFEMBREE is a fixed-dose combination oral tablet containing relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg.
What is MYFEMBREE used for?
MYFEMBREE is a GnRH antagonist / Estrogen replacement / Progestin and is used to treat the following:
- Heavy menstrual bleeding related to uterine fibroids in women who haven’t reached menopause
- Moderate-to-severe pain related to endometriosis in women who haven’t reached menopause
How does MYFEMBREE work?
MYFEMBREE is a combination of three medications. Relugolix is a gonadotropin-releasing hormone (GnRH) antagonist. GnRH is a natural hormone in the body that plays a role in making estrogen and progesterone hormones. These hormones all play a role in maintaining your reproductive system. Relugolix blocks the actions of GnRH, which lowers the estrogen and progesterone levels in your body. This lessens bleeding that happens with uterine fibroids and pain from endometriosis. Estradiol is an estrogen replacement. It replaces some of the estrogen in your body that’s lost from relugolix. Replacing estrogen might help prevent bone loss. Norethindrone is a progestin (a lab-made form of progesterone). It replaces some of the progesterone in your body that’s lost from relugolix. This might help protect the uterus from damage from the effects of estrogen alone, which might help prevent uterine (endometrial) cancer.
How do I take MYFEMBREE?
MYFEMBREE is typically taken as 1 tablet by mouth once a day around the same time each day, with or without food. It’s recommended to take the medication for a maximum of 2 years because of the risk for bone loss.
Is it safe for me to take MYFEMBREE?
MYFEMBREE is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:
- High risk of arterial, venous thrombotic, or thromboembolic disorder
- Pregnancy
- Known osteoporosis
- Current or history of breast cancer or other hormone-sensitive malignancies
- Known hepatic impairment or disease
- Undiagnosed abnormal uterine bleeding
- Known hypersensitivity to components of MYFEMBREE
MYFEMBREE Common Side Effects
Common side effects of MYFEMBREE:
- New or worsening high blood pressure
- Unusual or irregular vaginal bleeding
- Hair loss or hair thinning
- Headache
- Hot flashes, a lot of sweating, or night sweats
- Mood problems or mood swings
- Unusual vaginal bleeding
- Nausea
MYFEMBREE Serious Side Effects
Serious side effects are rare with MYFEMBREE. Contact your healthcare provider immediately if you experience any of the following.
- Blood clot: swelling or redness in the leg, shortness of breath, chest pain
- Heart attack: shortness of breath, arm or chest pain, sweating
- Stroke: slurred speech, vision changes, facial drooping, sudden weakness on one side of the body, sudden headache
- Liver or gallbladder problems: yellowing of your skin or eyes (jaundice), pain in the upper right part of your stomach, nausea, vomiting, dark urine
- Uterine fibroid that comes out into the vagina: heavy menstrual bleeding, severe cramping
- Suicidal thoughts or behavior
- Serious allergic reaction: swelling in the face, tongue, or throat; trouble breathing; hives
Effects of other drugs, drug classes and over-the-counter products on MYFEMBREE
The following medications may interact with MYFEMBREE:
- Avoid use of MYFEMBREE with oral P-gp inhibitors
- Avoid use with combined P-gp and strong CYP3A inducers, as the exposure of the components of MYFEMBREE may be decreased
Who makes MYFEMBREE?
Sumitomo Pharma
Is MYFEMBREE safe in pregnancy?
MYFEMBREE is contraindicated in pregnancy. Based on findings from animal studies and its mechanism of action, MYFEMBREE may cause early pregnancy loss. Discontinue MYFEMBREE if pregnancy occurs during treatmentThere is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MYFEMBREE during pregnancy. Pregnant females exposed to MYFEMBREE and healthcare providers are encouraged to call the MYFEMBREE Pregnancy Exposure Registry at 1-855-428-0707.
What to do if you missed your MYFEMBREE dose
The FDA's medical product safety reporting program for health professionals, patients and consumers.
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Medical Disclaimer
NowPatient has taken all reasonable steps to ensure that all material is factually accurate, complete, and current. However, the knowledge and experience of a qualified healthcare professional should always be sought after instead of using the information on this page. Before taking any drug, you should always speak to your doctor or another qualified healthcare provider.
The information provided here about medications is subject to change and is not meant to include all uses, precautions, warnings, directions, drug interactions, allergic reactions, or negative effects. The absence of warnings or other information for a particular medication does not imply that the medication or medication combination is appropriate for all patients or for all possible purposes.
Things to know
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