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Save Up To 75% With This Enjuvia Discount Card!

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  • Boston.com
Estimated Savings Of Over $9,855,778

Always pay a fair price for your medication!

Our FREE Enjuvia discount card helps you save money on the exact same Enjuvia prescription you're already paying for. Print the card in seconds, then take it to your pharmacy the next time you get your Enjuvia prescription filled. Hand it to them and save between 10% - 75% off this prescription!

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ENJUVIA prescribing information
This information is not for clinical use. These highlights do not include all the information needed to use Enjuvia safely and effectively.
Before taking Enjuvia please consult with your doctor. See full prescribing information for Enjuvia.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)]. Cardiovascular Disorders and Probable Dementia Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3),and Clinical Studies (14.3, 14.4)]. The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo [see Warnings and Precautions (5.1),and Clinical Studies (14.3)]. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.4)]. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. 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. Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.3, 14.4)]. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1),and Clinical Studies (14.3)]. The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.4)]. Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.2), and Clinical Studies (14.3)]. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. 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. WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-alone Therapy • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.2) • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia (5.1, 5.3) • The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) (5.1) • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.3) Estrogen Plus Progestin Therapy • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (5.1, 5.3) • The WHI estrogen plus progestin substudy reported increased risks of, DVT, pulmonary embolism (PE), stroke, and myocardial infarction (MI) (5.1) • The WHI estrogen plus progestin study reported increased risks of invasive breast cancer (5.2) • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.3)
1 INDICATIONS AND USAGE ENJUVIA (synthetic conjugated estrogens, B) is a mixture of estrogens indicated for: •Treatment of Moderate to Severe Vasomotor Symptoms due to menopause (1.1). •Treatment of Moderate to Severe Vaginal Dryness and Pain with Intercourse, Symptoms of Vulvar and Vaginal Atrophy, due to menopause (1.2). Limitation of Use When prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Vaginal Dryness and Pain with Intercourse, Symptoms of Vulvar and Vaginal Atrophy, due to Menopause Limitation of Use When prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered.
3 DOSAGE FORMS AND STRENGTHS ENJUVIA is available as tablets in 0.3 mg, 0.45 mg 0.625 mg, 0.9 mg, and 1.25 mg strengths. •0.3 mg tablet •0.45 mg tablet •0.625 mg tablet •0.9 mg tablet •1.25 mg tablet
4 CONTRAINDICATIONS ENJUVIA therapy is contraindicated in women with any of the following conditions: •Undiagnosed abnormal genital bleeding. •Known, suspected, or history of breast cancer. •Known or suspected estrogen-dependent neoplasia. •Active DVT, PE, or a history of these conditions. •Active or recent arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. •Known liver impairment or disease. •Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders •Known or suspected pregnancy. •Undiagnosed abnormal genital bleeding (4, 5.2) •Known, suspected, or history of cancer of the breast (4, 5.2) •Known or suspected estrogen-dependent neoplasia (4, 5.2) •Active DVT, PE, or a history of these conditions (4, 5.1) •Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.1) •Known liver impairment or disease (4, 5.10) •Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (4) •Known or suspected pregnancy (4, 8.1)
5 WARNINGS AND PRECAUTIONS •Estrogens increase the risk of gallbladder disease (5.4) •Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs (5.5, 5.6, 5.9, 5.10) •Monitor thyroid function in women on thyroid replacement therapy (5.11, 5.18) 5.1 Cardiovascular Disorders An increased risk of stroke and DVT has been reported with estrogen-alone therapy. An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. Stroke In the WHI estrogen-alone substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving CE (0.625 mg)-alone compared to women in the same age group receiving placebo (45 versus 33 per 10,000 women-years). The increase in risk was demonstrated in year 1 and persisted [see Clinical Studies (14.3)]. Should a stroke occur or be suspected, estrogen-alone therapy should be discontinued immediately. Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women receiving CE (0.625 mg)-alone versus those receiving placebo (18 versus 21 per 10,000 woman-years).1 In the WHI estrogen-plus-progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years) [see Clinical Studies (14.3)]. The increase in risk was demonstrated after the first year and persisted.1 Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. Coronary Heart Disease In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as non-fatal MI, silent MI, or CHD death) was reported in women receiving estrogen-alone compared to placebo2 [see Clinical Studies (14.3)]. Subgroup analyses of women 50 to 59 years of age suggest a statistically non-significant reduction in CHD events (CE [0.625 mg]-alone compared to placebo) in women with less than 10 years since menopause (8 versus 16 per 10,000 women-years). In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of CHD events reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years).1 An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5 [see Clinical Studies (14.3)]. In postmenopausal women with documented heart disease (n = 2,763, average 66.7 years of age), in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study [HERS]), treatment with daily CE (0.625 mg) plus MPA (2.5 mg) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE plus MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand, three hundred and twenty-one (2,321) women from the original HERS trial agreed to participate in an open-label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE (0.625 mg) plus MPA (2.5 mg) group and the placebo group in HERS, HERS II, and overall. Venous Thromboembolism In the WHI estrogen-alone substudy, the risk of VTE (DVT and PE) was increased for women receiving daily CE (0.625 mg)-alone compared to placebo (30 versus 22 per 10,000 women-years), although only the increased risk of DVT reached statistical significance (23 versus 15 per 10,000 women years). The increase in VTE risk was demonstrated during the first 2 years3 [see Clinical Studies (14.3)]. Should a VTE occur or be suspected, estrogen-alone therapy should be discontinued immediately. In the WHI estrogen plus progestin substudy, a statistically significant 2-fold greater rate of VTE was reported in women receiving CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (35 versus 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000 women-years) and PE (18 versus 8 per 10,000 women-years) were also demonstrated. The increase in VTE risk was demonstrated during the first year and persisted4 [see Clinical Studies (14.3)]. Should a VTE occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. 5.2 Malignant Neoplasms Endometrial Cancer An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in a woman with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2 to 12 times greater than in non-users, and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with use of estrogens for less than 1 year. The greatest risk appears associated with prolonged use, with increased risks of 15- to 24-fold for 5 to 10 years or more, and this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued. Clinical surveillance of all women taking estrogen-alone or estrogen plus progestin therapy is important. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. Adding a progestin to postmenopausal estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Breast Cancer The most important randomized clinical trial providing information about breast cancer in estrogen-alone users is the WHI substudy of daily CE (0.625 mg)-alone. In the WHI estrogen-alone substudy, after an average follow-up of 7.1 years daily CE-alone was not associated with an increased risk of invasive breast cancer (relative risk [RR] 0.80)5 [see Clinical Studies (14.3)]. The most important randomized clinical trial providing information about breast cancer in estrogen plus progestin users is the WHI substudy of daily CE (0.625 mg) plus MPA (2.5 mg). After a mean follow-up of 5.6 years, the estrogen plus progestin substudy reported an increased risk of invasive breast cancer in women who took daily CE plus MPA. In this substudy, prior use of estrogen-alone or estrogen plus progestin therapy was reported by 26 percent of the women. The relative risk of invasive breast cancer was 1.24, and the absolute risk was 41 versus 33 cases per 10,000 women-years, for CE plus MPA compared with placebo6 [see Clinical Studies (14.3)]. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 versus 25 cases per 10,000 women-years, for CE plus MPA compared with placebo. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 versus 36 cases per 10,000 women-years for CE plus MPA compared with placebo. In the same substudy, invasive breast cancers were larger, were more likely to be node positive, and were diagnosed at a more advanced stage in the CE (0.625 mg) plus MPA (2.5 mg) group compared with the placebo group. Metastatic disease was rare, with no apparent difference between the two groups. Other prognostic factors, such as histologic subtype, grade, and hormone receptor status did not differ between the groups [see Clinical Studies (14.3)]. Consistent with the WHI clinical trials, observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy, and a smaller increased risk for estrogen-alone therapy, after several years of use. The risk increased with duration of use, and appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). Observational studies also suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared to estrogen-alone therapy. However, these studies have not found significant variation in the risk of breast cancer among different estrogen plus progestin combinations, doses, or routes of administration. The use of estrogen-alone and estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. Ovarian Cancer The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE plus MPA versus placebo was 1.58 (95 percent CI, 0.77-3.24). The absolute risk for CE plus MPA versus placebo was 4 versus 3 cases per 10,000 women-years.7 In some epidemiologic studies, the use of estrogen plus progestin and estrogen-only products, in particular for 5 or more years, has been associated with an increased risk of ovarian cancer. However, the duration of exposure associated with increased risk is not consistent across all epidemiologic studies, and some report no association. 5.3 Probable Dementia In the WHIMS estrogen-alone ancillary study of WHI, a population of 2,947 hysterectomized women 65 to 79 years of age was randomized to daily CE (0.625 mg)-alone or placebo. After an average follow-up of 5.2 years, 28 women in the estrogen-alone group and 19 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent CI, 0.83-2.66). The absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000 women-years8 [see Use in Specific Populations (8.5), and Clinical Studies (14.4)]. In the WHIMS estrogen plus progestin ancillary study, a population of 4,532 postmenopausal women 65 to 79 years of age was randomized to daily CE (0.625 mg) plus MPA (2.5 mg) or placebo. After an average follow-up of four years, 40 women in the CE plus MPA group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.21-3.48). The absolute risk of probable dementia for CE plus MPA versus placebo was 45 versus 22 cases per 10,000 women-years8 [see Use in Specific Populations (8.5), and Clinical Studies (14.4)]. When data from the two populations in the WHIMS estrogen-alone and estrogen plus progestin ancillary studies were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, 1.19-2.60). Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see Use in Specific Populations (8.5), and Clinical Studies (14.4)]. 5.4 Gallbladder Disease A 2 to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. 5.5 Hypercalcemia Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. 5.6 Visual Abnormalities Retinal vascular thrombosis has been reported in women receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued. 5.7 Addition of a Progestin When a Woman Has Not Had a Hysterectomy Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer . 5.8 Elevated Blood Pressure In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogens on blood pressure was not seen. 5.9 Hypertriglyceridemia In women with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs. 5.10 Hepatic Impairment and/or Past History of Cholestatic Jaundice Estrogens may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued. 5.11 Hypothyroidism Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Women with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range. Women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These women should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. 5.12 Fluid Retention Estrogens may cause some degree of fluid retention. Women with conditions that might be influenced by this factor, such as a cardiac or renal impairment, warrant careful observation when estrogen-alone is prescribed. 5.13 Hypocalcemia Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur. 5.14 Exacerbation of Endometriosis A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy. For women known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered. 5.15 Hereditary Angioedema Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema. 5.16 Exacerbation of Other Conditions Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. 5.17 Laboratory Tests Serum follicle stimulating hormone (FSH) and estradiol levels have not been shown to be useful in the management of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy. 5.18 Drug/Laboratory Test Interactions 1.Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. 2.Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Women on thyroid replacement therapy may require higher doses of thyroid hormone. 3.Other binding proteins may be elevated in serum, (for example, corticosteroid binding globulin [CBG], sex hormone binding globulin [SHBG]) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations, such as testosterone and estradiol, may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). 4.Increased plasma high-density lipoprotein (HDL) and HDL2 cholesterol subfraction concentrations, reduced low-density lipoprotein (LDL) cholesterol concentration, and increased triglyceride levels. 5.Impaired glucose tolerance.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: •Cardiovascular Disorders [see Boxed Warnings, Warnings and Precautions (5.1)] •Malignant Neoplasms [see Boxed Warnings, Warnings and Precautions (5.2)] The most common adverse reactions (≥10%) are abdominal pain, headache, pain, nausea, and breast pain (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 12-week clinical trial, 209 postmenopausal women with vasomotor symptoms were treated with ENJUVIA. Adverse reactions that occurred in the study at a rate greater than or equal to 3% and greater than placebo are summarized in Table 1 . Table 1: Number (%) of Women Reporting Adverse Reactions with ≥3 Percent Occurrence Rate and Greater than Placebo by Body System and Treatment Group Body System/Adverse Reaction 0.3 mg n=68 0.625 mg n=72 1.25 mg n=69 Placebo n=72 Number of Patients in Safety Sample (%) 68 (100) 72 (100) 69 (100) 72 (100) Number of Patients with Adverse Reactions (%) 49 (72) 55 (76) 56 (81) 51 (71) Number of Patients without Adverse Reactions (%) 19 (28) 17 (24) 13 (19) 21 (29) Body as a Whole Abdominal Pain 3 (4) 11 (15) 3 (4) 7 (10) Accidental Injury 6 (9) 2 (3) 3 (4) 5 (7) Asthenia 2 (3) 3 (4) 2 (3) 0 Chest Pain 2 (3) 3 (4) 0 0 Chills 0 3 (4) 1 (1) 1 (1) Flu Syndrome 4 (6) 3 (4) 5 (7) 3 (4) Headache 10 (15) 18 (25) 11 (16) 15 (21) Pain 10 (15) 14 (19) 7 (10) 6 (8) Digestive System Constipation 3 (4) 2 (3) 1 (1) 2 (3) Diarrhea 4 (6) 2 (3) 3 (4) 4 (6) Flatulence 3 (4) 5 (7) 3 (4) 2 (3) Nausea 5 (7) 7 (10) 8 (12) 6 (8) Metabolic and Nutritional Disorders Peripheral Edema 1 (2) 3 (4) 3 (4) 2 (3) Nervous System Depression 2 (3) 3 (4) 1 (1) 1 (1) Dizziness 5 (7) 3 (4) 1 (1) 3 (4) Emotional Lability 2 (3) 3 (4) 1 (1) 1 (1) Paresthesia 0 4 (6) 1 (1) 0 Respiratory System Bronchitis 0 3 (4) 5 (7) 3 (4) Cough Increased 1 (2) 2 (3) 3 (4) 2 (3) Pharyngitis 3 (4) 2 (3) 0 0 Rhinitis 3 (4) 4 (6) 5 (7) 4 (6) Sinusitis 2 (3) 3 (4) 5 (7) 2 (3) Skin and Appendages Acne 0 3 (4) 1 (1) 0 Fungal Dermatitis 1 (2) 0 3 (4) 1 (1) Pruritus 2 (3) 2 (3) 4 (6) 3 (4) Urogenital System Breast Pain 0 9 (13) 10 (15) 3 (4) Dysmenorrhea 1 (2) 6 (8) 1 (1) 2 (3) Vaginitis 1 (2) 5 (7) 2 (3) 3 (4) In a second 12-week clinical trial, 310 women with symptoms of vulvar and vaginal atrophy were treated (154 women with ENJUVIA 0.3 mg tablets and 156 women with placebo). Adverse reactions that occurred in the study at a rate greater than or equal to 3% and greater than placebo are summarized in Table 2 . Table 2: Number (%) of Women Reporting Adverse Reactions with ≥3 Percent Occurrence Rate and Greater than Placebo by Body System and Treatment Group Body System/Adverse Reaction 0.3 mg n=154 Placebo n=156 Number of Patients in Safety Sample (%) 154 (100) 156 (100) Number of Patients with Adverse Reactions (%) 83 (54) 74 (47) Number of Patients without Adverse Reactions (%) 71 (46) 82 (53) Infections and Infestations Upper Respiratory Tract Infection 6 (4) 4 (3) Sinusitis 5 (3) 2 (1) Reproductive System and Breast Disorders Breast Tenderness 6 (4) 1 (1) Musculoskeletal and Connective Tissue Disorders Back Pain 6 (4) 2 (1) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ENJUVIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: abdominal discomfort, abdominal distension, nausea Immune System Disorders: anaphylactic reaction, hypersensitivity Musculoskeletal and connective tissue disorders: muscle spasms Nervous System Disorders: headache, dizziness Psychiatric disorders: insomnia Reproductive system and Breast Disorders: breast pain, breast tenderness Skin and Subcutaneous Tissue Disorders: alopecia, rash, urticaria Vascular Disorders: deep vein thrombosis, thrombosis
7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with ENJUVIA. •Inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) may affect estrogen drug metabolism (7.1) 7.1 Metabolic Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John’s wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice, may increase plasma concentrations of estrogens and may result in side effects.
8 USE IN SPECIFIC POPULATIONS •Nursing Mothers: Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of breast milk (8.3) •Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Women’s Health Initiative Memory ancillary studies of the Women’s Health Initiative (5.3, 8.5) 8.1 Pregnancy ENJUVIA should not be used during pregnancy [see Contraindications (4)]. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. 8.3 Nursing Mothers ENJUVIA should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen-alone therapy. Caution should be exercised when ENJUVIA is administered to a nursing woman. 8.4 Pediatric Use ENJUVIA is not indicated in children. Clinical studies have not been conducted in the pediatric population. 8.5 Geriatric Use There have not been sufficient numbers of geriatric women involved in studies utilizing ENJUVIA to determine whether those over 65 years of age differ from younger subjects in their response to ENJUVIA. The Women’s Health Initiative Studies In the WHI estrogen-alone substudy (daily CE [0.625 mg)-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies (14.3)]. In the WHI estrogen-plus-progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.3)]. The Women’s Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see Warnings and Precautions (5.3), and Clinical Studies (14.4)]. Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see Warnings and Precautions (5.3), and Clinical Studies (14.4)]. 8.6 Renal Impairment The effect of renal impairment on the pharmacokinetics of ENJUVIA has not been studied. 8.7 Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of ENJUVIA has not been studied.

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Medication Discount Card Medication Discount Card
Frequently Asked Questions

There are no catches to this. Simply print the card, take it to your pharmacy, and save. If you still have questions just read below...

How Do I Know My Pharmacy Will Accept It?
That's simple. The card is accepted at ALL CHAIN PHARMACIES such as CVS, Rite Aid, and Walgreens. If you don't know if your pharmacy accepts the card simply call them and give them the BIN and PCN numbers on the card. The card is accepted at most pharmacies. If you call a few one is sure to accept it.
Can I Use This In Conjunction With My Insurance?
No, unfortunately insurance companies don't allow "double-savings". However, if your insurance does not cover certain drugs (ex - cosmetic drugs, brand names, prenatal vitamins, etc) then this card may save you money. Also if your insurance requires you to pay a deductible on your brand name drugs before covering them, then this card may also provider greater savings!
How Much Will This Card Save Me?
You can expect to save between 10% - 75% off standard retail pricing. The discount varies depending on what type and brand of drug (generic or brand-name) you are purchasing.
This Sounds Too Good To Be True. Is This A Scam?
Absolutely not. As you can see there are no fees, ever. We will never ask for credit card information at any time. The reason this card works is simply because pharmacies are willing to provide a discount in order to earn your business.
My Pharmacy Isn't Included. Can They Participate?
Yes! There are pharmacies who accept the pharmacy savings card that are not on our list. If you find one please email us and we'll update the list. If they are not a current partner and are interested, email us and we'll contact them to try and convince them to participate. You may also choose to call around and see if someone else in your area accepts it.
Is this the same as an Enjuvia copay card?
No this is not a copay card, It is good for the cash paying customer and cannot be used to reduce your copay.
Savings of 70%!
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Savings of over $200!
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Savings of over 50%!
I had printed out 3 different discount cards on the internet and asked the pharmacist to check prices. The lowest price was $289. I searched the internet some more, I found this site, gave the pharmacy your card and the cost was $130. What a big savings, I can't thank this site enough. - Linda S.

Accepted at over 59,000 pharmacies nationwide including

Accepted At Over 59,000 Pharmacies Nationwide!

Including...
  • Including...
  • Cub Pharmacy
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  • Winn Dixie
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And thousands of independent pharmacies nationwide!

Enjuvia Coupon

Currently we do not have any available, however you can receive an instant discount at your pharmacy with our Enjuvia discount card. Create one instantly

Important Note

The information on this website is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

This prescription discount card cannot be used in conjunction with insurance. However, some members find they save more when using the card rather than there prescription coverage.

This Enjuvia discount should not be confused with an Enjuvia coupon while they are essentially the same this discount card only needs to be handed to your pharmacist once and will provide continuous savings every time your prescription is filled. The only time you will need to use it again is if you change pharma

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"Wow! I can`t believe this actually worked. I have no insurance at this time and have to pay
I lost my insurance coverage and went online seeking help and found this CARD! It worked and saved me money $$$$$ very 1st time. There are others out there but with less coverage and a smaller list of drugs or they charge you a monthly fee. I am so happy I take 3 prescriptions a month forever and at times more and I will save over 78% as I figured it out, and that is great tell everybody you know as I am doing."
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Save up to 75% on your medication
Save up to 75% on your medication