Uses
What is Myfembree used for?
Myfembree (relugolix/estradiol/norethindrone) is commonly used for the following conditions.
- Heavy menstrual bleeding associated with uterine fibroids
- Moderate to severe pain associated with endometriosis
Learn more about Myfembree for uterine fibroids and endometriosis.
Myfembree may also be used for other conditions as determined by your healthcare provider.
How does Myfembree work (mechanism of action)?
Myfembree contains three medicines, relugolix, estradiol, and norethindrone. Relugolix lowers certain hormone levels to reduce symptoms such as bleeding with uterine fibroids and pain with endometriosis. Estradiol is a form of estrogen hormone that helps maintain bone health. Norethindrone is a progesterone hormone that balances the effects of estradiol and protects the uterus from any negative effects that might come from estrogen alone.
How is Myfembree supplied (dosage forms)?
Myfembree is available in the following dosage forms that are taken by mouth.
- 40 mg/1 mg/0.5 mg oral tablets
How should I store Myfembree?
Myfembree should be stored at room temperature, between 59 F to 86 F (15 C to 30 C).
Side Effects
What are the most common side effects of Myfembree?
The most common side effects of Myfembree are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Hot flushes
- Increased sweating
- Night sweats
- Abnormal vaginal bleeding, such as bleeding that lasts too long, that is too much, or is unexpected
- Decreased interest in sex
- Hair loss or hair thinning (heavy bleeding with uterine fibroids)
- Headache (pain with endometriosis)
- Mood changes including worsening depression (pain with endometriosis)
- Nausea (pain with endometriosis)
- Toothache (pain with endometriosis)
- Back pain (pain with endometriosis)
- Joint pain (pain with endometriosis)
- Tiredness (pain with endometriosis)
- dizziness (pain with endometriosis)
There may be other side effects of Myfembree that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Myfembree?
While less common, the most serious side effects of Myfembree are described below, along with what to do if they happen.
Severe Allergic Reactions. Myfembree may cause allergic reactions, which can be serious. Stop taking Myfembree and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Heart Attack and Stroke. Myfembree can increase your risk of a heart attack or stroke that can lead to death. This risk is increased if you are over 35 years old and smoke, or if you have uncontrolled high blood pressure. Do not take Myfembree if you have had a recent heart attack without talking to your healthcare provider. This could increase your risk of having another heart attack. Get emergency help if you have any of the following symptoms of a heart attack or stroke.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Double vision, bulging of the eyes, or sudden blindness, partial or complete
Blood Clots. Myfembree may increase your chance of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE). This risk is increased if you are over 35 years old, smoke, and have uncontrolled high blood pressure. Get emergency help if you have any of the following symptoms of a blood clot.
- Leg pain or swelling that will not go away
- Sudden shortness of breath
- Weakness or numbness in an arm or leg
Weak Bones. Using Myfembree for a long time may cause the bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause bones to break (fracture) more easily. If you use Myfembree, your healthcare provider may monitor your bone density.
Suicidal Thoughts and Actions. Myfembree may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.
- New or increased thoughts of suicide or death
- Suicide attempt
- New or increased feelings of anxiety, depression, or other unusual changes in your mood or behavior
Liver Injury. Myfembree may cause abnormal liver tests or liver injury. Call your healthcare provider right away if you have any of the following symptoms of liver problems.
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Dark-colored urine (pee)
- Feeling tired (fatigue or exhaustion)
- Nausea and vomiting
- Generalized swelling
- Right upper stomach area (abdomen) pain
- Bruising easily
Gallbladder Problems. Taking Myfembree can cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). The risk is higher if you have had certain gallbladder problems during pregnancy. Call your healthcare provider right away if you have any of the following symptoms.
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Fever
- Pain in your upper stomach area
- Stool (poop) that is clay-colored
Warnings & Precautions
Who should not use Myfembree?
Allergies to Ingredients. People who are allergic to any of the following should not take Myfembree.
- Myfembree
- Relugolix
- Estradiol
- Norethindrone
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Myfembree.
Current and Past Health Conditions. People who have or have had the following conditions should not take Myfembree.
- Blood clot disorders including deep vein thrombosis (DVT), pulmonary embolism (PE), or retinal thrombosis
- Stroke or heart attack
- A problem that makes your blood clot more than normal
- Blood circulation disorders or peripheral vascular disease (PVD)
- Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in your heart
- High blood pressure not well controlled by medicine
- Diabetes with kidney, eye, nerve, or blood vessel damage
- Certain types of migraine headaches
- Breast cancer or any cancer that is sensitive to female hormones
- Osteoporosis
- Vaginal bleeding that your healthcare provider has not diagnosed
- Liver problems
- Smoking if you are over 35 years old
Pregnancy. Do not take Myfembree if you are pregnant. If you become pregnant, contact your healthcare professional right away. See the Pregnancy section for more details.
What should I know about Myfembree before using it?
Do not take Myfembree unless it has been prescribed to you by a healthcare provider. Take it as prescribed. Take Myfembree at about the same time each day.
Do not share Myfembree with other people, even if they have the same condition as you. It may harm them.
Keep Myfembree out of the reach of children.
What should I tell my healthcare provider before using Myfembree?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Myfembree is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Broken bones or conditions that may cause bone problems
- Depression, mood swings, or suicidal thoughts or behavior.
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Jaundice caused by pregnancy (cholestasis of pregnancy)
- Scheduled for surgery or bed rest
- High blood pressure
- High cholesterol levels
- Stroke
- Heart problems such as heart attack or coronary artery disease (CAD)
- Blood circulation disorders or peripheral vascular disease (PVD)
- Obesity
- Smoking
Other Medicines and Supplements. Myfembree may interact with other medicines and supplements. Before using Myfembree, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Do not take Myfembree if you are pregnant or if you were recently pregnant. Myfembree can cause early pregnancy loss. It is not known if or how Myfembree could harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use Myfembree while you are pregnant or trying to get pregnant. If you become pregnant while taking Myfembree, you can register for the Myfembree Pregnancy Exposure Registry by calling 855-428-0707. This registry collects safety information about the use of Myfembree during pregnancy.
Breastfeeding. Myfembree may pass into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Myfembree while breastfeeding.
How can I get more information about Myfembree?
For more information about Myfembree, you can visit the manufacturer’s website at www.myfembree.com or call them at 833-696-8268.
Interactions
Does Myfembree interact with foods or drinks?
There are no known interactions between Myfembree and foods or drinks.
It is unknown if drinking alcohol will affect Myfembree.
Does Myfembree interact with other medicines (drug interactions)?
Myfembree interacts with many other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Many other medicines may alter the blood levels of Myfembree. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Myfembree. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Myfembree?
If you or someone else has used too much Myfembree, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Myfembree?
If you miss a dose, take it as soon as you remember that day. Then take Myfembree at the usual time the next day. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.