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A plant-derived oral estrogen, ENJUVIA delivers effective relief of moderate-to-severe vasomotor symptoms, and moderate-to-severe vaginal dryness and pain with sex to your symptomatic menopausal patients at doses as low as 0.3 mg per day. What's more, a unique delivery system provides slow release of estrogens over several hours. All of which means that the ENJUVIA Effect will be something you—and your patients—will be glad to discover.
ENJUVIA significantly reduces the frequency and severity of moderate-to-severe vasomotor symptoms and moderate-to-severe vaginal dryness and pain with sex, symptoms of vulvar and vaginal atrophy, associated with menopause.
ENJUVIA is the only oral estrogen that utilizes Surelease® technology combined with a cellulose-based polymer tablet design and provides slow release of estrogens, over several hours.
Important Safety Information
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.
The estrogen alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo.
The estrogen-plus-progestin substudy of the WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo.
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Other doses of oral conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
ENJUVIA tablets should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known hypersensitivity to the ingredients of ENJUVIA tablets; or known or suspected pregnancy. There is no indication for ENJUVIA in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.
The most common side effects in clinical trials were headache, pain, nausea, and breast pain.
In a clinical trial, adverse events that occurred at a rate greater than or equal to 5% and greater than placebo, regardless of relationship to study drug, included: headache, breast pain, nausea, pain, flu syndrome, bronchitis, rhinitis, sinusitis, abdominal pain, accidental injury, flatulence, vaginitis, dizziness, paresthesia, and dysmenorrhea.
ENJUVIA tablets are taken orally, once daily, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the treatment of moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. When prescribing solely for the treatment of moderate-to-severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. Patients should be started at the lowest approved dose of 0.3 mg ENJUVIA daily. Subsequent dosage adjustment may be made based upon the individual patient response. Dosage should be periodically reassessed by the healthcare provider.
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Surelease is a registered trademark of BPSI Holdings LLC.
ENJUVIA™ is a trademark, and Duramed® is a registered trademark, of Duramed Pharmaceuticals, Inc.
