Myfembree Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Myfembree is a prescription medicine used in premenopausal women to control heavy menstrual bleeding caused by uterine fibroids and to manage moderate to severe pain from endometriosis. It combines relugolix, estradiol, and norethindrone acetate in a once-daily tablet. It works by lowering certain hormone levels while adding back estrogen and a progestin to reduce some low-estrogen effects and protect the womb lining. Treatment should not continue for longer than 24 months.

What is Myfembree Tablet

Myfembree is a prescription medicine used in premenopausal women to control heavy menstrual bleeding caused by uterine fibroids and to manage moderate to severe pain from endometriosis. It comes as a once-daily tablet combining three hormone-related medicines: relugolix, estradiol, and norethindrone acetate. Its drug class is sex hormone combinations.

Myfembree Tablet uses

• Managing heavy menstrual bleeding caused by uterine fibroids in premenopausal women
• Managing moderate to severe pain associated with endometriosis in premenopausal women

Benefits of Myfembree Tablet

• Helps reduce heavy menstrual bleeding caused by uterine fibroids.
• Helps relieve moderate to severe pain from endometriosis.
• Can reduce painful periods (dysmenorrhea).
• May help decrease pelvic pain and pain during sex related to endometriosis.
• Helps control symptoms by lowering ovarian hormone activity while adding back estrogen and progestin to reduce some low-estrogen effects.

How Myfembree Tablet works

Myfembree combines three ingredients that work together: one lowers hormones like estrogen and progesterone to reduce fibroid bleeding and endometriosis pain; a form of estrogen is added back to help protect bone strength; and a progestin is included to protect the lining of the womb from the effects of estrogen.

Myfembree Tablet dosage

Take this medicine once a day at about the same time, with or without food. Start taking it as soon as possible after your period begins, but no later than 7 days after your period starts; starting on another day may cause heavier or irregular bleeding for the first month.

If you take a P-gp inhibitor medicine, take Myfembree first and wait at least 6 hours before taking that other medicine.

If you miss a dose, take it as soon as you remember that same day, then go back to your usual schedule the next day; do not take two doses in one day to make up for a missed dose.

This medicine does not prevent pregnancy, so use a non-hormonal method of birth control during treatment and for at least 1 week after stopping. Do not take hormonal birth control while on this medicine, as it may increase side effects and reduce how well this medicine works.

Treatment should not continue for longer than 24 months.

Available forms and strengths

• Tablets

Side effects of Myfembree Tablet

Common

• Hot flashes
• Increased sweating or night sweats
• Low interest in sex
• Hair loss or thinning
• Abnormal or irregular vaginal bleeding (lighter, shorter, longer, heavier, or missed periods)
• Headache
• Nausea
• Joint pain or back pain
• Tiredness
• Dizziness
• Toothache

Serious

• Signs of blood clots, heart attack, or stroke, such as leg pain or swelling, sudden shortness of breath, chest or jaw pain, sudden severe headache, or weakness/numbness on one side of the body
• Bone loss, which may increase the risk of fractures over time
• Mood changes, including new or worsening depression, anxiety, or suicidal thoughts
• Liver problems, such as jaundice, dark urine, fatigue, nausea, vomiting, swelling, or upper right abdominal pain
• Gallbladder problems (cholestasis)
• High blood pressure
• High blood sugar
• Increases in cholesterol and triglyceride levels
• Uterine fibroid prolapse or expulsion, with increased vaginal bleeding or cramping
• Severe allergic reaction, including swelling of the face, lips, mouth, tongue, or throat, or trouble breathing

Warnings and precautions

• This medicine has a boxed warning, the FDA's most serious warning, for an increased risk of blood clots and blood vessel problems, including stroke, heart attack, and clots in the legs or lungs, especially in people over 35 who smoke or have uncontrolled high blood pressure.
• This medicine can cause loss of bone density, which is why treatment should not last longer than 24 months.
• Do not take this medicine if you have or have had blood clots, stroke, heart attack, certain heart or blood clotting problems, poorly controlled high blood pressure, certain severe migraines, hormone-sensitive cancer, osteoporosis, unexplained vaginal bleeding, or liver disease.
• Do not take this medicine if you smoke and are over 35 years old, or if you've had a serious allergic reaction to it or its ingredients.
• This medicine may increase the risk of blood clots after surgery. Tell your healthcare provider if you have surgery planned, as you may need to stop the medicine beforehand.
• Do not take this medicine if you are pregnant or trying to become pregnant, since it may raise the risk of early pregnancy loss. It does not prevent pregnancy, so a non-hormonal birth control method should be used during treatment and for at least a week after stopping.
• It isn't known if this medicine is safe while breastfeeding. Talk to your healthcare provider about the safest way to feed your baby if you are taking this medicine.
• This medicine should generally not be used if you have liver problems or liver disease, as it may worsen your condition.
• There are no known direct interactions between this medicine and alcohol, but drinking alcohol during treatment could raise the risk of certain side effects, such as liver problems.

Storage

• Store at 20–25°C (68–77°F) at controlled room temperature.
• Keep in a cool, dry place away from excessive heat and humidity.
• Protect tablets from moisture and direct sunlight.
• Keep tablets in the original container or packaging until use.
• Avoid storing in bathrooms or other hot and humid areas.
• Keep out of reach and sight of children and pets.

When to see a doctor

• Stop taking this medicine and call your healthcare provider right away or go to the nearest emergency room if you have leg pain or swelling that won't go away, sudden shortness of breath, vision changes, chest/arm/jaw pain or pressure, a sudden severe headache, or weakness/numbness or trouble speaking.
• Get emergency medical help right away if you have thoughts about suicide, suicide attempts, new or worse depression or anxiety, or other unusual changes in mood or behavior.
• Call your healthcare provider right away if you notice signs of liver problems, such as yellowing skin or eyes, dark urine, fatigue, nausea and vomiting, swelling, upper right abdominal pain, or easy bruising.
• Call your healthcare provider right away if you have increased vaginal bleeding or cramping, which could mean a fibroid is partly or fully coming out through the vagina.
• If you think you might be pregnant, stop taking this medicine right away and call your healthcare provider.
• If you take too much of this medicine, call your healthcare provider or go to the nearest hospital emergency room right away.

Alternatives

• Progestin Therapy
• Combined Hormonal Contraceptives
• Norethindrone Acetate
• Lupron Depot (Leuprolide)
• Orilissa (Elagolix)