Mimvey is a combination hormone replacement therapy (HRT) that contains estradiol (an estrogen) and norethindrone (a progestin). It's used to treat certain symptoms of menopause, such as night sweats and vaginal dryness, related to low estrogen levels. It can also help prevent bone loss (osteoporosis) in females who've reached menopause. The typical dose is 1 tablet by mouth once daily. Some side effects of this medication include breast pain and headache. Mimvey (estradiol / norethindrone), as well as other HRTs, isn't recommended for people who've had breast cancer.
Mimvey is a branded generic of Activella, the brand name medication. Other generics that are like Mimvey include estradiol/norethindrone.
In females who have a healthy uterus:
Moderate-to-severe vasomotor symptoms (VMS) of menopause, like hot flashes and night sweats
Moderate-to-severe symptoms of vulvar and vaginal atrophy, like vaginal dryness
Prevention of osteoporosis in females who've reached menopause
Your ovaries make estrogen and progesterone, which are important hormones that help control your menstrual cycles. As the body ages and goes through menopause, your ovaries make less and less of these hormones. This can lead to certain symptoms, including hot flashes and night sweats.
Mimvey (estradiol / norethindrone) is hormone replacement therapy (HRT) that replaces estrogen and progesterone hormones during menopause:
Estradiol is an estrogen replacement. It lowers the risk of bone loss and eases certain symptoms of low estrogen, such as hot flashes, night sweats, and vaginal dryness.
Norethindrone is a progestin. It acts like progesterone and helps balance the effect of estrogen on the growth of your uterine lining.
Source:Â DailyMed
Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:
The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer, and no need to take an estrogen and progestin combination.
It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
More common
Breast pain or tenderness
dizziness or light-headedness
headache
rapid weight gain
swelling of feet and lower legs
vaginal bleeding
Rare
Breast lumps
change in vaginal discharge
discharge from nipple
pains in chest, groin, or leg, especially calf
pains in stomach, side, or abdomen
pain or feeling of pressure in pelvis
severe or sudden headache
sudden and unexplained shortness of breath
sudden loss of coordination
sudden slurred speech
sudden vision changes
weakness or numbness in arm or leg
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Taken by mouth once daily
Includes a progestin to protect against endometrial cancer
Available as a lower-cost generic medication
Raises your risk of blood clots, heart attack, and stroke
Not for people who've had breast cancer
Not a first-choice option for vaginal symptoms of menopause or for preventing osteoporosis
Take Mimvey (estradiol / norethindrone) once a day at the same time every day. You can use the calendar on the package to mark and keep track of your doses.
Mimvey (estradiol / norethindrone) can cause irregular vaginal bleeding, including breakthrough bleeding and spotting. This side effect is more likely to happen when you first start treatment and should get better over time. If you notice irregular vaginal bleeding, talk with your healthcare team. While this is an expected side effect, there's a rare chance that spotting or irregular bleeding might be a symptom of cervical cancer.
Taking an estrogen-containing medication, like Mimvey (estradiol / norethindrone), might lead to higher blood sugar levels or higher blood pressure. If you already have diabetes or high blood pressure, your healthcare team might ask you to check your blood pressure or blood sugar levels more often while you're taking Mimvey (estradiol / norethindrone).
Taking Mimvey (estradiol / norethindrone) might raise your risk for certain types of cancers, such as breast cancer and uterine cancer. Your healthcare team might ask you to have a pelvic exam, breast exam, and mammogram once a year while you're taking this medication. Ask your healthcare team if you're not sure how to schedule these screenings.
Since Mimvey (estradiol / norethindrone) can cause many bothersome side effects and serious risks, your healthcare team will likely recommend that you take the medication for the shortest period of time possible to treat your symptoms. Make sure to check in with your prescriber regularly to discuss if you still need to take Mimvey (estradiol / norethindrone).
Mimvey (estradiol / norethindrone) 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.
Risk factors: Personal or family history of blood clots | High blood pressure | Diabetes (high blood sugar) | High cholesterol | Tobacco use | Obesity | Systemic lupus erythematosus (SLE)
Estrogen/progestin oral HRTs, such as Mimvey (estradiol / norethindrone), and estrogen-only HRTs can raise your risk of blood clots. These blood clots can travel anywhere in your body and block blood flow, including your legs or arms (deep vein thrombosis, DVT) and your lungs (pulmonary embolism, PE). They can also travel to your heart, which can lead to a heart attack, or your brain, which can lead to a stroke. You're at higher risk of blood clots if you or anyone in your family has had them in the past, if you smoke tobacco, or if you have certain conditions, like high blood pressure and high cholesterol.
Let your healthcare professional (HCP) know you're using Mimvey (estradiol / norethindrone). Because of the risk of developing blood clots, you will need to stop using Mimvey (estradiol / norethindrone) before certain types of surgeries or periods of time when you won't be moving much. Your HCP will let you know how long before the surgery you need to stop using Mimvey (estradiol / norethindrone). To lower your risk of blood clots, wear compression leggings or get up and stretch often on long car or plane trips.
Let your HCP know if you have pain or swelling in your legs or arms, as this can be a symptom of a blood clot. Call 911 and get medical help right away if you have trouble breathing, chest or arm pain, facial drooping, weakness on one side of the body, severe headaches, or sudden changes in your speech or vision, since these can be signs of life-threatening complications of blood clots.
Risk factors: Personal or family history of breast cancer | Using hormonal therapy for a long period of time
Estrogen/progestin combination HRTs, like Mimvey (estradiol / norethindrone), can raise your risk of breast cancer. This risk might be higher compared to estrogen-only therapy. Don't use Mimvey (estradiol / norethindrone) if you currently have or have had breast cancer in the past. You're also at greater risk if you've used Mimvey (estradiol / norethindrone) or similar medications for a long period of time. To lower your risk of breast cancer, your HCP will prescribe the lowest dose of estrogen for the shortest period of time possible. It's important that you regularly check your breasts for any changes and get breast scans (mammograms) done. Let your healthcare professional know if you notice any unusual changes in breast shape, size, or color.
Risk factors: Estrogen therapy without additional progestin | People with a healthy uterus | Using estrogen therapy for more than 1 year | High estrogen dose
Mimvey (estradiol / norethindrone) contains estradiol, which works like estrogen in your uterus. It can change the lining of your uterus, called the endometrium. Uncontrolled growth of the uterus lining can cause uterine or endometrial cancer in people with a healthy uterus. This risk is especially high in people taking estrogen therapy without a progestin to balance out estrogen's effect on the growth of the uterine lining. You can still have the risk of uterine cancer several years after stopping your hormonal therapy.
People using Mimvey (estradiol / norethindrone) might have a lower risk of uncontrolled endometrial growth compared to those taking estrogen-only therapy, since Mimvey (estradiol / norethindrone) contains a progestin. Regardless of the hormonal therapy you're taking, it's important to be aware of the warning signs of uterine (endometrial) cancer, including vaginal bleeding that doesn't go away or keeps coming back. Let your HCP know if you notice any unusual vaginal bleeding. If you're worried about getting uterine cancer, talk to your HCP.
Risk factors: Age 65 years or older
People taking estrogen/progestin combinations or estrogen-only therapy might be at greater risk for dementia. Your risk is higher if you start hormonal therapy after age 65. Estrogen/progestin combination and estrogen-only therapies shouldn't be used to prevent dementia. Early symptoms of dementia include new forgetfulness, confusion, getting lost, and wandering out into the neighborhood. If the risk of dementia worries you, talk to your HCP.
Estrogen/progestin combinations and estrogen-only therapy can potentially raise the risk of ovarian cancer in females using HRTs. If you notice any unusual vaginal bleeding, vaginal discharge, or pelvic pain, talk to your healthcare professional (HCP). These can be signs of ovarian cancer.
Risk factors: History of liver disease or jaundice
Estrogen therapy can raise the risk of gallbladder disease. Let your HCP know if you've had jaundice (yellowing of your skin or eyes, or dark urine) in the past. If your jaundice comes back while using Mimvey (estradiol / norethindrone), stop the medication and talk to your HCP. These can be signs of liver damage or gallbladder disease.
Risk factors: Breast cancer | Cancer that has spread to the bones | Low parathyroid hormone levels
Estrogen therapy can change the calcium levels in your blood. Females with breast cancer that has spread to the bones are at higher risk of extremely high calcium levels. Symptoms of high calcium levels include feeling tired and having muscle weakness, nausea, vomiting, or constipation.
On the other hand, females with low parathyroid hormone levels from the parathyroid gland are at higher risk of low calcium levels during estrogen therapy. Symptoms of low calcium levels include muscle spasms or twitching and numbness and tingling in your fingers, toes, or around your mouth.
Let your HCP know if you notice any of these symptoms. You might need regular blood tests done so that your HCP can check your calcium levels while you're taking Mimvey (estradiol / norethindrone).
Although very rare, some people taking estrogens have had vision problems due to clot formation in the eyes. If you have sudden partial or complete vision loss, bulging eyes, double vision, or migraines, stop Mimvey (estradiol / norethindrone) and tell your HCP.
Risk factors: History of high triglyceride levels in the blood
Estrogen therapy might raise the triglyceride (fat) levels in your blood. Too much triglyceride in your blood can lead to problems in your pancreas, including swelling (pancreatitis). You might need to get blood tests done regularly while taking Mimvey (estradiol / norethindrone) so your HCP can make sure your pancreas is healthy. If you experience signs of pancreatitis, like stomach pain that spreads to your back, stomach tenderness, fever, nausea, or vomiting, let your HCP know right away.
Risk factors: Conditions that cause low thyroid hormone levels
Estrogens can cause changes in the thyroid hormone levels in your body. If you have conditions that cause low thyroid hormone levels, your body can't adjust these levels to keep them in the normal range. If you're taking thyroid replacement medication for your thyroid condition, you might need to take a higher dose. You also might need to get regular blood tests done while using Mimvey (estradiol / norethindrone) to make sure your thyroid hormone levels are normal.
Risk factors: Certain heart conditions | Kidney damage
Estrogen/progestin combination therapies can cause excess fluids to build up inside your body. Signs of fluid retention include swelling of your hands and ankles. You're at higher risk of fluid retention if you have certain heart conditions, like heart failure, or kidney damage. If you have these conditions, let your HCP know if you notice any signs of worsening fluid retention while using Mimvey (estradiol / norethindrone).
Taking estrogen-containing medications can worsen certain medical conditions. These include high blood pressure, hereditary angioedema, asthma, diabetes, migraine, and seizures. Before you start Mimvey (estradiol / norethindrone) let your healthcare team know about your past medical history so they can talk with you about the risks and benefits of taking this medication.
Dosage | Quantity | Price as low as | Price per unit |
---|---|---|---|
28 tablets of 1mg/0.5mg | 3 packages | $56.17 | $18.72 |
Each Mimvey tablet contains 1 mg of estradiol and 0.5 mg of norethindrone.
Adults: The typical dose is 1 tablet by mouth once daily.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Undiagnosed abnormal vaginal bleeding
History of breast cancer
History of other estrogen-sensitive cancer or tumor
History of blood clots traveling to your extremities (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE)
History of heart attack or stroke
Liver disease
Blood clotting conditions
In females who have a healthy uterus:
Moderate-to-severe vasomotor symptoms (VMS) of menopause, like hot flashes and night sweats
Moderate-to-severe symptoms of vulvar and vaginal atrophy, like vaginal dryness
Prevention of osteoporosis in females who've reached menopause
Moderate-to-severe vasomotor symptoms of menopause, such as hot flashes and night sweats
Moderate-to-severe vaginal dryness, burning, and irritation caused by menopause
Hot flashes and night sweats due to menopause
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Amneal Pharmaceuticals LLC. (2023). Activella- estradiol/norethindrone acetate tablet, film coated [packaged insert]. DailyMed.
MedlinePlus. (n.d.). Gallbladder disease.
Marsh, M. S., et al (1994). Paradoxical effects of hormone replacement therapy on breast tenderness in postmenopausal women. Maturitas.
Nappi, R. E., et al. (2001). Course of primary headaches during hormone replacement therapy. Maturitas.
Teva Pharmaceuticals USA, Inc. (2024). Mimvey- estradiol and norethindrone acetate tablet, film coated [package insert]. DailyMed.
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