Myfembree (relugolix/estradiol/norethindrone) is a brand-name prescription medication. It’s FDA-approved to manage heavy periods caused by uterine fibroids. These fibroids are growths on or in the uterus that aren’t cancer.
Myfembree is prescribed to adult females* who haven’t yet gone through menopause.
It’s important to note that Myfembree shouldn’t be taken for longer than 24 months. This is because the medication may cause bone loss that can’t be reversed.†
* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
† For more information about bone loss, see “Side effect details” in the “Myfembree side effects” section below.
Myfembree comes as an oral tablet that contains three different active ingredients:
Myfembree comes in one strength. Each tablet contains 40 milligrams (mg) of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone.
The Food and Drug Administration (FDA) approved Myfembree in May 2021. The drug is the first oral medication taken once daily to manage heavy periods caused by uterine fibroids in adult females who haven’t gone through menopause.
For information about the effectiveness of Myfembree, see the “Myfembree uses” section below.
Myfembree is available only as a brand-name medication. It’s not currently available in generic form.
A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.
The Food and Drug Administration (FDA) approves prescription drugs such as Myfembree to treat certain conditions. Myfembree may also be used off-label for other conditions. Off-label prescribing is when a drug is prescribed for a purpose other than its FDA-approved use.
Myfembree is FDA-approved to manage heavy periods caused by uterine fibroids. The drug is for use in adult females* who haven’t yet gone through menopause.
* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
Uterine fibroids are growths on or in the walls of the uterus that aren’t cancer. The uterus is an organ in the pelvis where a fetus develops during pregnancy.
Uterine fibroids are common in females who are able to become pregnant. Fibroids are made up of smooth muscle tissue. They range from 1 millimeter (mm) to 20 centimeters (cm) in diameter or larger. As a comparison, 20 cm is about the size of a grapefruit.
With uterine fibroids, some people have no symptoms while others have severe symptoms. It depends on the location, size, and number of fibroids present. Common symptoms can include:
Myfembree is approved to manage heavy periods caused by uterine fibroids. For help managing other symptoms related to uterine fibroids, such as constipation, talk with your doctor.
It’s important to note that doctors typically will not prescribe Myfembree treatment for longer than 24 months. This is because the medication may cause bone loss that can’t be reversed. (To learn more about this bone loss, see “Side effect details” in the “Myfembree side effects” section below.)
Clinical studies have shown that Myfembree is an effective treatment for heavy periods caused by uterine fibroids. For information about how the drug performed in clinical studies, see Myfembree’s prescribing information.
You can also learn additional facts about periods and more by visiting our female health hub.
Myfembree is only approved for use in adult females. It isn’t known if the drug is safe or effective for children.
Myfembree can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Myfembree. These lists do not include all possible side effects.
For more information about the possible side effects of Myfembree, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Myfembree, you can do so through MedWatch.
Mild side effects* of Myfembree can include:
Most of these side effects may go away within a few days to a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.
* This is a partial list of mild side effects from Myfembree. To learn about other mild side effects, talk with your doctor or pharmacist, or refer to Myfembree’s prescribing information.
† For more information about this side effect, see “Side effect details” below.
Serious side effects from Myfembree aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
* For more information about this side effect, see “Side effect details” below.
† Myfembree has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.
If you or someone you know is in crisis and considering suicide or self-harm, please seek support:
If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.
If you’re not in the same household, stay on the phone with them until help arrives.
Here’s some detail on certain side effects this drug may cause.
Myfembree has a boxed warning about blood clots and blood vessel disorders. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.
Two of Myfembree’s active ingredients are hormones. Estradiol is a type of estrogen, and norethindrone is a type of progestin (a synthetic form of progesterone). Drugs that contain these hormones are known to cause an increased risk of blood clots and serious cardiovascular problems. “Cardiovascular” refers to the heart and blood vessels.
Rarely, Myfembree may cause blood clots.* Specific types of blood clots that may occur include deep vein thrombosis (DVT) and pulmonary embolism (PE). Blood clots can cause serious cardiovascular problems such as a heart attack or stroke.
Some people may have an increased risk of developing blood clots and related cardiovascular problems. Because of this, doctors typically will not prescribe Myfembree if you have certain risk factors for these conditions. The risk factors include having:
Another risk factor is smoking and being older than age 35 years.
* For more information about how often this side effect occurred in clinical studies, see Myfembree’s prescribing information.
Symptoms of blood clots
You should call your doctor or seek immediate medical care if you have symptoms of a blood clot. Symptoms of DVTs and PEs can vary, but may include:
If you have questions about your risk of blood clots while taking Myfembree, talk with your doctor.
Bone mineral density describes bone strength. Loss of bone mineral density may occur with Myfembree. Specifically, bone loss in the lower back was reported in some people who took the drug for up to 1 year in clinical studies.*
Decreased bone mineral density or bone loss may lead to osteoporosis (weak and brittle bones) and bone fractures. But it isn’t known if taking Myfembree further increases your risk of future fractures.
It’s not possible to reverse bone loss due to Myfembree by stopping treatment with the drug. Because of this long-term side effect risk, your doctor will likely prescribe Myfembree for no longer than 24 months.
Before and during Myfembree treatment, your doctor may order a bone mineral density test called a DEXA scan. This test checks the strength of your bones.
To help prevent bone loss, your doctor may recommend that you take calcium and vitamin D supplements. Calcium helps strengthen bones and vitamin D helps your body absorb calcium. If you have questions about your risk of bone loss with Myfembree, talk with your doctor.
* For more information about how often this side effect occurred in clinical studies, see Myfembree’s prescribing information.
Hair loss is one of the most common side effects of taking Myfembree. Hair loss and hair thinning were reported as common side effects during the drug’s clinical studies.*
In the studies, some people described their hair loss as moderate. Most people continued to take the drug despite this side effect.
No specific pattern of hair loss has been reported with Myfembree treatment. It isn’t yet known if this side effect can be reversed by stopping treatment with the drug.
If you’re concerned about hair loss with Myfembree, talk with your doctor. They’ll help you consider the pros and cons. If your heavy periods caused by uterine fibroids are severe, the benefit of taking this medication may outweigh the risk of hair loss or thinning. Your doctor may also suggest ways to help prevent or reduce hair loss.
* For more information about how often this side effect occurred in clinical studies, see Myfembree’s prescribing information.
As with most drugs, some people can have an allergic reaction after taking Myfembree. It isn’t clear how often allergic reactions occurred during the drug’s clinical studies.
Symptoms of a mild allergic reaction can include:
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
Call your doctor right away if you have an allergic reaction to Myfembree, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
The following information describes dosages that are commonly taken or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Myfembree comes as an oral tablet.
Myfembree is available in one strength that’s a fixed combination of its three active ingredients. Each tablet contains 40 milligrams (mg) of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone.
The typical dosage of Myfembree is one tablet, once daily. It’s best to take your dose at about the same time each day. This helps keep a steady level of the drug in your system so it can work effectively.
If you take certain medications that interact with Myfembree, it’s important to take your dose of Myfembree at least 6 hours before your other medications. (For more information, see the “Myfembree interactions” section below or ask your pharmacist.)
It’s recommended that you take your first dose of Myfembree as soon as possible after the start of your period. But you can still take the drug within 7 days after your period begins.
If you start taking Myfembree outside of this 7-day window, your period may become heavier or irregular. But this should occur only just after starting treatment. And the bleeding should become lighter by your next period.
If you have questions about when to take Myfembree, talk with your doctor.
If you miss a dose of Myfembree, take it as soon as possible within the same day. Then take your next dose at your usual time the following day. You should not take two doses of Myfembree within the same day to make up for a missed dose.
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Myfembree is meant to be taken as a long-term treatment for a maximum of 24 months. This is because the medication may cause bone loss that can’t be reversed. (For more information about bone loss, see “Side effect details” in the “Myfembree side effects” section above.)
If you and your doctor determine that Myfembree is safe and effective for you, you’ll likely take it for up to 24 months.
Other drugs are available that can treat heavy periods caused by uterine fibroids. Some may be a better fit for you than others. If you’re interested in finding an alternative to Myfembree, talk with your doctor. They can tell you about other medications that may work well for you.
Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.
Examples of other drugs that may be used to treat heavy periods caused by uterine fibroids include:
As with all medications, the cost of Myfembree can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Keep in mind that you may be able to get a 90-day supply of Myfembree. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.
Before approving coverage for Myfembree, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.
If you’re not sure if you’ll need to get prior authorization for Myfembree, contact your insurance company.
If you need financial support to pay for Myfembree, or if you need help understanding your insurance coverage, help is available.
Myovant Sciences GmbH, the manufacturer of Myfembree, offers ways to save on the drug. For more information and to find out if you’re eligible for support, visit its website. There, you can learn more about cost savings based on whether you:
Myfembree may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.
If recommended by your doctor, you may be able to receive a 90-day supply of Myfembree, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.
If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.
Myfembree is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.
Here are answers to some frequently asked questions about Myfembree.
Myfembree doesn’t get rid of or cure uterine fibroids (growths on or in the uterus that aren’t cancer). The medication is used to treat a common symptom of uterine fibroids: heavy periods. Taking Myfembree may help make your periods lighter.
The only cure for heavy periods caused by uterine fibroids is a hysterectomy (surgery to remove your uterus).
Your doctor can provide more information about ways to treat uterine fibroids or manage related symptoms.
No, Myfembree is not a type of birth control, and it does not prevent pregnancy. There are types of birth control that may help lighten periods, but Myfembree isn’t one of them.
Myfembree is used to manage heavy periods caused by uterine fibroids.
It’s important to note that you should use nonhormonal birth control while taking Myfembree. For details, see the “Myfembree and birth control” section below.
If you have questions about using birth control during Myfembree treatment, talk with your doctor or pharmacist.
Yes, you may need certain tests before taking Myfembree, and there are specific instructions about when to start taking the drug.
Before you start treatment with Myfembree, your doctor may have you take a pregnancy test to confirm that you’re not pregnant. The drug is not safe to use in pregnancy. Taking Myfembree while pregnant may increase the risk of pregnancy loss. To learn more, see the “Myfembree and pregnancy” section below.
Your doctor may also order a bone mineral density test called a DEXA scan. This scan checks the strength of your bones. Myfembree may cause bone loss, which can lead to osteoporosis (weak and brittle bones) and an increased risk of bone fractures. For more information about bone loss, see “Side effect details” in the “Myfembree side effects” section above.
There are special instructions for when to start Myfembree. The timing depends on your period. For details, see the “Myfembree dosage” section above.)
If you have additional questions about tests and instructions regarding Myfembree, talk with your doctor.
Alcohol shouldn’t interact with Myfembree.
However, drinking alcohol may increase the risk of certain side effects of Myfembree or make them more severe. These side effects* can include:
If you drink alcohol, talk with your doctor about how much is safe to consume while taking Myfembree.
* For more information about these side effects, see the “Myfembree side effects” section above.
† Myfembree has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.
Myfembree can interact with several other medications.
Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.
Below are some medications that can interact with Myfembree. This section does not contain all drugs that may interact with Myfembree.
Before taking Myfembree, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Some medications can reduce the effectiveness of Myfembree or increase the risk of side effects such as blood clots.* Some examples of these medications include:
* Myfembree has a boxed warning about blood clots. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous. To learn more, see “Side effect details” in the “Myfembree side effects” section above.
Taking Myfembree and drugs called P-glycoprotein (P-gp) inhibitors too close together can cause Myfembree to be less effective at treating your condition.
Because of this risk, it’s important to separate doses of P-gp inhibitor drugs from doses of Myfembree. You’ll likely take Myfembree first, then wait at least 6 hours to take your other medications.
Some examples of commonly prescribed P-gp inhibitors include:
There aren’t any herbs or supplements that have been specifically reported to interact with Myfembree. However, you should still check with your doctor or pharmacist before using any of these products while taking Myfembree.
There aren’t any foods that have been specifically reported to interact with Myfembree.
However, grapefruit is known to interact with other medications that contain estrogen. (Myfembree contains estradiol, a type of estrogen.) Consuming grapefruit or grapefruit juice with Myfembree may increase the level of estrogen in your body, which can raise your risk of side effects.*
If you have any questions about eating certain foods with Myfembree, talk with your doctor.
* For more about side effects, see the “Myfembree side effects” section above.
You should take Myfembree according to the instructions your doctor gives you.
Myfembree is an oral tablet that you swallow.
You’ll likely take Myfembree once per day. It’s best to take it at about the same time each day. This helps keep a steady level of the drug in your system so it can work effectively.
If you take certain medications that can interact with Myfembree, you may have to adjust when you take them and Myfembree. For more information, see the “Myfembree interactions” section above or ask your pharmacist.
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
You may take Myfembree with or without food.
It isn’t known if it’s safe to crush, split, or chew Myfembree tablets. In clinical studies, the medication was swallowed whole.
If you have trouble swallowing Myfembree tablets, talk with your doctor or pharmacist. They may suggest ways to help you take these tablets or discuss other options with you.
Myfembree is approved to manage heavy periods caused by uterine fibroids. These fibroids are growths on or in the uterus that aren’t cancer. The drug is for use in adult females* who haven’t yet gone through menopause.
It isn’t fully understood what causes uterine fibroids, but it may be related to hormones. Fibroids tend to shrink or swell over time depending on the levels of the sex hormones estrogen and progesterone. When a person’s hormone levels are high, such as during pregnancy, fibroids tend to swell. When a person’s hormone levels are low, such as after menopause, fibroids tend to shrink.
Heavy periods are a common symptom of uterine fibroids.
The hormones estrogen and progesterone play a role in your menstrual cycle and the thickness of the uterus lining. (When the lining sheds, you have your period.) Myfembree works by lowering the levels of estrogen and progesterone in your body. This helps reduce heavy menstrual bleeding.
Myfembree starts to work shortly after you take a dose. So it’s important to start treatment as soon as possible after your period begins. But you can take your first dose within 7 days from when your period starts.
In clinical studies, some females* experienced lighter periods within 4 weeks of Myfembree treatment.
If you don’t notice relief from heavy periods within a few months of taking Myfembree, talk with your doctor.
*Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
Myfembree is not safe to take while pregnant or while trying to become pregnant. Taking the drug during pregnancy may cause early pregnancy loss.
Keep in mind that Myfembree may cause changes in your menstrual cycle, such as lighter periods or missed periods. But Myfembree doesn’t prevent pregnancy. Missed periods can be a sign that you’re pregnant.
If you miss periods while taking Myfembree, you should take a pregnancy test. If you’re pregnant, tell your doctor right away. They’ll likely have you stop taking the drug.
If you become pregnant while taking Myfembree, you’re encouraged to join a pregnancy registry. Pregnancy registries help medical professionals collect information about the safety of certain drugs. This information can help you make informed decisions about treatments during pregnancy.
You can learn more by talking with your doctor or calling the Myfembree Pregnancy Exposure Registry at 855-428-0707.
Myfembree is not safe to take while pregnant or while trying to become pregnant.* Taking the medication may increase the risk of early pregnancy loss. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Myfembree.
While taking Myfembree, you should use effective nonhormonal birth control, such as condoms. You should continue to use nonhormonal birth control for at least 1 week after your last dose of Myfembree.
Hormonal birth control (such as birth control pills, patches, or vaginal rings) should not be used with Myfembree. This is because the combination may increase the risk of estrogen-related side effects, such as blood clots.† The combination may also interact in a way that makes Myfembree less effective than usual.
Before starting Myfembree treatment, be sure to tell your doctor about any birth control you currently use. If it contains hormones, they’ll likely have you switch to nonhormonal birth control before you start taking Myfembree.
* For more information about Myfembree and pregnancy, see the “Myfembree and pregnancy” section above.
† Myfembree has a boxed warning about blood clots. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous. To learn more, see “Side effect details” in the “Myfembree side effects” section above.
Your doctor will likely recommend that you don’t take Myfembree while you’re breastfeeding. Although the drug hasn’t been studied in people who were breastfeeding, research in animals showed that Myfembree is likely to pass into breast milk. The drug’s effects on a child who is breastfed aren’t known.
If you’re breastfeeding or planning to breastfeed, tell your doctor before starting Myfembree. They’ll talk with you about your options, including other ways to manage heavy periods.
This drug comes with several precautions.
Myfembree has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
Myfembree contains forms of the hormones estrogen and progestin. Medications that contain these hormones are known to increase the risk of blood clots and cardiovascular disorders. (The term cardiovascular means related to the heart and blood vessels.) Types of blood clots that may occur include deep vein thrombosis and pulmonary embolism. These blood clots can cause serious cardiovascular problems such as a heart attack or stroke.
Because of this risk, doctors typically will not prescribe Myfembree if you have certain risk factors for these conditions. The risk factors include:
For more information about this boxed warning, see “Side effect details” in the “Myfembree side effects” section above.
Before taking Myfembree, talk with your doctor about your health history. Myfembree may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
* For more information, see “Side effect details” in the “Myfembree side effects” section above.
Taking more than the recommended dosage of Myfembree can lead to serious side effects. Do not take more Myfembree than your doctor recommends.
Myfembree contains a form of estrogen and a form of progestin. An overdose of these hormones can cause symptoms such as:
If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.
When you get Myfembree from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to take it.
How long a medication remains good to use can depend on many factors, including how and where you store the medication.
You should store Myfembree tablets at room temperature, 59°F to 86°F (15°C to 30°C), in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.
If you no longer need to take Myfembree and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Oriahnn (elagolix/estradiol/norethindrone) is a prescription drug that reduces heavy menstrual bleeding from fibroids. Learn about costs, dosage, and…
Uterine artery embolization is a minimally invasive procedure that doctors may use to manage pelvic bleeding. Learn more about its uses and what to…
Natural treatments may help relieve the symptoms of uterine fibroids, though there is little research that they are effective. In this article, we…
Types of AUB include acute and chronic. Chronic occurs over a long period, whereas acute can occur infrequently and spontaneously. Read more.
Doctors may suggest treatments involve estrogen for people with atypical bleeding. Learn how it works, the procedure, risks, and more here.
OUR BRANDS
source
