Myfembree
Myfembree is a combination medication containing relugolix, estradiol, and norethindrone. It's used to manage heavy menstrual bleeding related to uterine fibroids. This medication can also help relieve pain from endometriosis. Myfembree is approved for use in women who haven't reached menopause and is a tablet that's taken once daily. Common Myfembree side effects include hot flashes and headaches.
What is Myfembree?
What is Myfembree used for?
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 Myfembree works
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.
Drug Facts
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What are the side effects of Myfembree?
Common Side Effects
- Hot flashes, a lot of sweating, or night sweats (11%)
- New or worsening high blood pressure (7%)
- Unusual or irregular vaginal bleeding (6%)
- Hair loss or hair thinning (4%)
- Headache (33%)
- Hot flashes, a lot of sweating, or night sweats (13%)
- Mood problems or mood swings (9%)
- Unusual vaginal bleeding (7%)
- Nausea (6%)
Other Side Effects
- Vaginal dryness
- Lowered sex drive
- Tiredness
- Dizziness
- Indigestion
- Diarrhea
- Back or joint pain
- Toothache
- Breast cyst
- Swelling in the hands, feet, or ankles
- Higher cholesterol levels
Serious Side Effects
- 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
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Gallbladder problems—severe stomach pain, nausea, vomiting, fever
- Heavy vaginal bleeding
- Increase in blood pressure
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Thoughts of suicide or self-harm, worsening mood, or feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Change in sex drive or performance
- Dizziness
- Fatigue
- Hair loss
- Headache
- Hot flashes
Pros and cons of Myfembree
Pros
Only taken once a day
Can also provide relief from pain and symptoms related to uterine fibroids like pelvic pressure or discomfort
Can relieve different types of pain from endometriosis (e.g., pain during your menstrual period, pelvic pain unrelated to your period)
Cons
Might have irregular menstrual bleeding patterns
Can raise the risk of blood clots, heart attacks, or strokes
Recommended to take for a maximum of 2 years because of the risk for bone loss
Pharmacist tips for Myfembree
Start taking Myfembree as soon as possible when your period starts, but no later than 7 days after it starts. You might have irregular or heavy menstrual bleeding at the beginning of treatment if you start the medication later in your cycle.
If you can get pregnant and are sexually active, make sure to use reliable nonhormonal birth control while you're taking Myfembree. This medication can cause early pregnancy loss (miscarriage) if it's taken during pregnancy. Stop the medication and let your provider know right away if you get pregnant during treatment.
Be sure to get your bone imaging scans done on time so your provider can check your bone strength and your risk for bone loss while you're taking Myfembree. Your provider might recommend taking calcium and vitamin D supplements, eating foods rich in these nutrients, and doing weight-bearing exercises to help strengthen your bones.
Tell your provider if you have a surgery or procedure planned. Myfembree can raise your risk of blood clots after surgery. Your provider might give you instructions on when to stop the medication before the procedure and when to restart it afterwards.
Check your blood pressure regularly at home, especially if you have high blood pressure. Myfembree can make your blood pressure go up. Call your provider if your blood pressure goes up by a lot.
If you have prediabetes or diabetes, you might need to check your blood sugar levels more often. Myfembree can raise your blood sugar.
Follow up with your provider about blood tests that you might need, such as cholesterol tests. Myfembree can raise the cholesterol and triglyceride (fat) levels in your blood. High levels can raise your risk for blood clots and can also sometimes lead to pancreatitis. You might need to stop the medication if these levels get too high.
Before you start any new medications, check with your pharmacist about whether your medications are safe to take with Myfembree. Some medications can raise your risk for Myfembree side effects like hot flashes or make Myfembree work less well. Your providers can tell you whether you need to avoid certain medications or separate others from Myfembree by a few hours to avoid drug interactions.
Frequently asked questions about Myfembree
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What are the risks and warnings for Myfembree?
Myfembree can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blood clots, heart attacks, and strokes
Risk factors: Conditions that raise the risk of blood clots | History of blood clots | Female over the age of 35 and smoke cigarettes | Uncontrolled high blood pressure | High cholesterol | Considered as obese
Myfembree can raise your risk for blood clots. Blood clots can be very dangerous and lead to a life-threatening heart attack, stroke, or pulmonary embolism (blood clot in the lungs).
There are several medical conditions that can raise the risk for blood clots even further, such as smoking among females over 35 years old and a history of blood clots. Be sure to discuss all the medical conditions you have or have had with your provider before you start Myfembree. Don't take this medication if you've had blood clots before (including stroke or heart attack) or if you have a condition that makes your blood clot more than normal.
Call 911 or get medical help right away if you have leg, arm, or chest pain; sudden and severe headaches; trouble breathing; or sudden changes in your speech or vision.
Bone loss
Risk factors: History of broken bones | Osteoporosis | Taking medications that weaken bones (e.g., corticosteroids, antiseizure medications, certain acid reflux medications) | Taking Myfembree for a long time
Myfembree can cause bone loss. Taking the medication for a long time can put you at higher risk for bone loss. This is why it's recommended that you take Myfembree for up to a maximum of 2 years.
Your provider will check your bone strength (bone mineral density or BMD) through imaging scans occasionally while you're taking Myfembree. After your treatment ends, your bones might partially recover. But there's a chance that there might not be complete recovery. It's not known whether this bone loss can raise your risk for broken bones as you get older.
Talk to your provider about the risks and benefits of taking Myfembree if you have a history of broken bones or if you're at high risk for osteoporosis or bone loss. Don't take this medication if you have osteoporosis.
Can't take if you have certain hormone-sensitive cancers
Because Myfembree contains the sex hormones estrogen and progesterone, it's possible that it can make cancers that are sensitive to these hormones grow. Tell your provider about your medical history before you start Myfembree. You won't be able to take the medication if you've had or are at risk for certain hormone-sensitive cancers, such as breast cancer.
If it's safe for you to start Myfembree, it's recommended that you get regular breast examinations and mammograms during treatment. You'll need to stop the medication if your provider finds cancer tissue in your breast. Let your provider know right away if you develop any symptoms of breast cancer, such as a new lump in your breast or armpit or discharge from your nipple.
Change in menstrual bleeding patterns
Changes in your menstrual bleeding patterns can happen while you're taking Myfembree. You might have irregular and heavy bleeding at the beginning of treatment if you start the medication later than 7 days after your period starts. Myfembree can also lessen how much or how long you bleed during your period. It can sometimes make your period stop altogether. Speak with your provider if you're concerned about any unusual bleeding patterns.
Not able to recognize pregnancy and risk of early pregnancy loss
Myfembree can change your menstrual bleeding patterns, such as less bleeding, shorter bleeding time, or no periods at all. These changes can make it harder for you to recognize that you're pregnant if you're sexually active.
If you can become pregnant and you're sexually active, you should use nonhormonal birth control while you're taking Myfembree and for 1 week after your last dose. It's important to prevent pregnancy while you're taking Myfembree because the medication can cause miscarriage. Stop Myfembree and tell your provider right away if you become pregnant.
Be sure to use nonhormonal birth control while you're taking Myfembree. Since Myfembree contains estradiol (a form of estrogen), taking hormonal birth control that has estrogen in it can raise your estrogen levels. This can make you more likely to have side effects from estrogen, like bloating, stomach cramps, and weight gain. It can also raise your risk of blood clots. Estrogen-containing birth control can also affect how well Myfembree works.
Depression, mood changes, and suicidal behavior
Risk factors: History of depression or other mental health conditions
People who take Myfembree have had depression, irritability, anxiety, and suicidal thoughts and behavior. Let your provider know right away if you or anyone around you notices that you have any new or worsening dark thoughts or changes in your mood or behavior, especially shortly after you start taking Myfembree. Get medical attention as soon as possible if you start having thoughts of harming yourself while you're taking this medication.
Liver or gallbladder problems
Risk factors: History of liver disease | History of jaundice related to previous estrogen medication use or pregnancy
Myfembree might raise the risk for liver damage or gallbladder problems. Before you start this medication, make sure to tell your provider about your medical history. Don't take Myfembree if you have a liver condition. Let your provider know right away if you have symptoms of liver or gallbladder problems, like yellowing of your skin or eyes (jaundice), pain in upper right part of your stomach, nausea or vomiting that doesn't go away, or dark urine.
Risk of your fibroid coming out into the vagina
It's possible for your uterine fibroid to completely or partially come out of your vagina during treatment with Myfembree. Get medical help if you have severe bleeding or cramping while you're taking this medication.
Changes to certain lab test results
Myfembree can cause changes to certain lab test results, like for thyroid, steroid, and blood clotting levels. Your provider might adjust the dose of any thyroid or cortisol medications that you might be taking to account for their related lab changes.
Myfembree dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 40mg/1mg/0.5mg | 28 tablets | $1207.02 | $43.11 |
Typical dosing for Myfembree
The typical dose is 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.
Each tablet of Myfembree contains 40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone.
How much does Myfembree cost?
Myfembree contraindications
Current or history of blood clots in legs or lungs
Conditions that affect your blood circulation
Heart valve problems or heart rhythm conditions that can cause blood clots to form (e.g., atrial fibrillation or AFib)
Conditions that makes your blood clot more than normal
Uncontrolled high blood pressure
Over 35 years of age and smoke
Over 35 years of age and have migraine headaches with aura
Currently pregnant
Current or history of certain types of cancer that's sensitive to hormones (e.g., breast)
Liver problems
Unexplained vaginal bleeding that hasn't been diagnosed
What are alternatives to Myfembree?
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
Heavy menstrual bleeding associated with uterine fibroids in premenopausal women
Moderate-to-severe pain caused by endometriosis
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References
Best studies we foundAl-Hendy, A., et al. (2021). Treatment of uterine fibroid symptoms with relugolix combination therapy. The New England Journal of Medicine.
American Cancer Society. (2019). What is endometrial cancer?
Becker, C.M., et al. (2024). Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study. Human Reproduction.
Cauley, J.A. (2015). Estrogen and bone health in men and women. Steroids.
Giudice, L.C., et al. (2022). Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2). The Lancet.
Hormone Health Network. (2014). What does estrogen do? The Journal of Clinical Endocrinology & Metabolism.
Kim, J. J., et al. (2010). Role of progesterone in endometrial cancer. Seminars in Reproductive Medicine.
MedlinePlus. (2023). Bone mineral density test.
Myfembree. (n.d.). UF efficacy data.
Sumitomo Pharma America, Inc. (2023). MYFEMBREE- relugolix, estradiol hemihydrate, and norethindrone acetate tablet, film coated [package insert]. DailyMed.
Syed, Y.Y., et al. (2022). Relugolix/Estradiol/Norethisterone (Norethindrone) Acetate: A Review in Symptomatic Uterine Fibroids. Drugs.
You and Your Hormones. (2021). Gonadotrophin-releasing hormone.
Your and Your Hormones. (2021). Progesterone.
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