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ENJUVIA is an FDA-approved oral estrogen therapy that has been shown to provide relief of moderate-to-severe menopausal hot flashes, night sweats, vaginal dryness, and pain with sex, which are symptoms associated with menopause. It is a plant-derived formulation of 10 synthetic estrogens. The ENJUVIA delivery system provides slow release of estrogens over several hours.
ENJUVIA has been shown to significantly lower the number of moderate-to-severe hot flashes and night sweats, also known as vasomotor symptoms, which women in menopause often experience. In most women, ENJUVIA also makes these symptoms less severe. ENJUVIA has been shown to relieve hot flashes and night sweats at doses as low as 0.3 mg. Estrogen therapy should be limited to the lowest effective dose for the shortest duration, consistent with treatment goals, benefits, and risks for the individual woman. If you suffer from hot flashes and night sweats associated with menopause, ask your healthcare professional if ENJUVIA is right for you.
Other symptoms of menopause may include irregular periods, weight gain, vaginal dryness, problems sleeping, dry skin, and mood swings. ENJUVIA is indicated for the treatment of moderate-to-severe vaginal dryness, but is not indicated for the treatment of these other symptoms.
Vaginal dryness is a common symptom of menopause. The tissues of the vagina become thin and dry when you produce less estrogen. There is also a decrease in vaginal fluid and lubrication. These changes may cause burning and itching. Sexual intercourse may become uncomfortable or even painful.
ENJUVIA has been shown to significantly relieve moderate-to-severe vaginal dryness and pain with sex at doses as low as 0.3 mg. Estrogen therapy should be limited to the lowest effective dose for the shortest duration, consistent with treatment goals, benefits, and risks for the individual woman. If you suffer from vaginal dryness and pain with sex, associated with menopause, ask your healthcare professional if ENJUVIA is right for you.*
Other symptoms of menopause may include irregular periods, weight gain, hot flashes, problems sleeping, dry skin, and mood swings. ENJUVIA is indicated for the treatment of moderate-to-severe hot flashes, but is not indicated for the treatment of these other symptoms.
ENJUVIA, like other hormone therapies, has risks. Estrogens increase the risk for uterine cancer. If you experience persistent or recurring vaginal bleeding while taking estrogens, let your healthcare professional know right away, as this could be a warning sign of cancer. Your healthcare professional should check for the cause of any unusual vaginal bleeding after menopause.
Estrogens (alone or in combination with progestins) may increase the risk of heart attack, stroke, blood clots, and breast cancer. Estrogens (alone or in combination with progestins) may increase your risk of dementia, based on a study of women age 65 or older.
Because of these risks, estrogen (alone or in combination with progestins) should be used at the lowest possible effective dose, for the shortest possible time.
You and your healthcare professional should talk regularly to determine whether you will need treatment with ENJUVIA.
You and your healthcare professional should talk about your symptoms to decide what is best for you. The length of time you will use ENJUVIA depends on your individual needs. Estrogen therapy should be limited to the lowest effective dose for the shortest duration, consistent with treatment goals, benefits, and risks for the individual woman.
If you forget to take ENJUVIA, take your daily dose as soon as you remember. If it is almost time to take your next ENJUVIA tablet, skip the missed dose and go back to your regular schedule. Do not "double up" your dose.
ENJUVIA is not right for everyone. You should not use ENJUVIA if you may be pregnant; have unusual vaginal bleeding; have a history of certain cancers, blood clots, or liver problems; have had a stroke or heart attack in the past year; or are allergic to ENJUVIA or any of its ingredients.
Bioidentical hormones are compounds that are often prepared, mixed, assembled, packaged, and labeled as a drug by a pharmacist. These compounds are often claimed to be "all-natural" or safer than FDA-approved therapies. However, because certain good drug manufacturing requirements may not apply to compounding pharmacies, it is unknown whether these mixtures contain the correct amount of hormone, or if they will be absorbed properly.
Further, no bioidentical hormones have met the standards of rigorous clinical testing by the FDA. This testing is done to ensure the safety, effectiveness, and safe manufacturing conditions of prescribed drugs.
Unlike bioidentical hormones, ENJUVIA is an FDA-approved oral estrogen therapy that has been shown to provide relief of moderate-to-severe menopausal hot flashes, night sweats, vaginal dryness, and pain with sex, which are symptoms associated with menopause.
For additional information about hormone therapy, please click on Resources for a list of other related Web sites.
Important information you should know when taking estrogens like ENJUVIA™:
ENJUVIA is a medicine that contains estrogen hormones. It is prescribed for relief of moderate-to-severe hot flashes and night sweats, and moderate-to-severe vaginal dryness and pain with intercourse, symptoms associated with menopause.
Estrogens increase the risk for cancer of the uterus (womb). If you experience persistent or recurring vaginal bleeding while taking estrogens let your doctor know right away, as this could be a warning sign for cancer. Your doctor should check for the cause of any unusual vaginal bleeding after menopause. Estrogens (alone, or in combination with progestins) should not be used to prevent heart disease, heart attacks, strokes, or dementia.
Estrogens (alone or in combination with progestins) may increase the risk of heart attack, stroke, blood clots, and breast cancer. Estrogens (alone or in combination with progestins) may increase your risk of dementia, based on a study of women age 65 or older. Because of these risks, estrogens should be used at the lowest dose for the shortest period of time. You and your doctor should talk regularly to determine whether you still need treatment with ENJUVIA.
Who should not use ENJUVIA?
Do not use ENJUVIA if you:
What are the common side effects with ENJUVIA?
You may experience headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, or hair loss.
Please see Patient Information section of the prescribing information.
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