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ENJUVIA

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Overview

What is ENJUVIA?

ENJUVIA® (synthetic conjugated estrogens, B) tablets contain a blend of ten (10) synthetic estrogenic substances. The estrogenic substances are: sodium estrone sulfate, sodium equilin sulfate, sodium 17α-dihydroequilin sulfate, sodium 17α-estradiol sulfate, sodium 17β-dihydroequilin sulfate, sodium 17α-dihydroequilenin sulfate, sodium 17β-dihydroequilenin sulfate, sodium equilenin sulfate, sodium 17β-estradiol sulfate, and sodium Δ-dehydroestrone sulfate.

The structural formulae for these estrogens are:

ENJUVIA tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, B. These tablets contain the following inactive ingredients: ascorbyl palmitate, butylated hydroxyanisole, colloidal silicon dioxide, edetate disodium dehydrate, plasticized ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, purified water, iron oxide red, titanium dioxide, polyethylene glycol, polysorbate 80, triacetate and triacetin/glycerol. In addition, the 0.45 mg tablets contain iron oxide black and iron oxide yellow; the 0.9 mg tablets also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake and FD&C yellow no. 6 aluminum lake; and the 1.25 mg tablets contain iron oxide yellow.



What does ENJUVIA look like?



What are the available doses of ENJUVIA?

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What should I talk to my health care provider before I take ENJUVIA?

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How should I use ENJUVIA?

ENJUVIA tablets are indicated in the:

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see and ).  For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

ENJUVIA tablets are taken orally, once daily for:

Patients should be started at the lowest approved dose of 0.3 mg ENJUVIA daily. Subsequent dosage adjustment (which will differ depending on the indication) may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.


What interacts with ENJUVIA?


  • 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.
    • 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. (See .)



What are the warnings of ENJUVIA?

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1. Cardiovascular disorders

Estrogen and estrogen/progestin therapies have been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism (VTE)). Should any of these occur or be suspected, estrogens should be discontinued immediately.

Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

2. Malignant neoplasms

3. Dementia

In the estrogen-alone Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 2,947 hysterectomized women aged 65 to 79 years was randomized to CE (0.625 mg daily) or placebo. In the estrogen-plus-progestin WHIMS substudy, a population of 4,532 postmenopausal women aged 65 to 79 years was randomized to CE/MPA (0.625 mg/2.5 mg daily) or placebo.

In the estrogen-alone substudy, 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 vs. placebo was 1.49 (95% CI 0.83-2.66). The absolute risk of probable dementia for CE alone vs. placebo was 37 vs. 25 cases per 10,000 women-years.

In the estrogen-plus-progestin substudy, after an average follow-up of four years, 40 women in the estrogen-plus-progestin group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for estrogen plus progestin vs. placebo was 2.05 (95% CI 1.21-3.48). The absolute risk of probable dementia for CE/MPA vs. placebo was 45 vs. 22 cases per 10,000 women-years.

When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95% CI 1.19-2.60). Since both substudies were conducted in women aged 65 to 79 years, it is unknown whether these findings apply to younger postmenopausal women. (See and , and .)

4. Gallbladder disease

A two- to four-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.

5. Hypercalcemia

Estrogen administration may lead to severe hypercalcemia in patients 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.

6. Visual abnormalities

Retinal vascular thrombosis has been reported in patients 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.


What are the precautions of ENJUVIA?

A. General

B. Information for Patients

Physicians are advised to discuss the leaflet with patients for whom they prescribe ENJUVIA tablets.

C. Laboratory Tests

Estrogen administration should be initiated at the lowest dose approved for the indication and then guided by clinical response rather than by serum hormone levels (e.g., estradiol, FSH).

D. Drug/Laboratory Test Interactions













              E. Carcinogenesis, Mutagenesis, Impairment of Fertility

              See and .

              Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.

              F. Pregnancy

              ENJUVIA tablets should not be used during pregnancy. (See .)

              G. Nursing Mothers

              Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when ENJUVIA is administered to a nursing woman.

              H. Pediatric Use

              The safety and efficacy of ENJUVIA tablets in pediatric patients has not been established.

              I. Geriatric Use

              Clinical studies of ENJUVIA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

              Of the total number of subjects in the estrogen-alone substudy of the WHI study, 46 percent (n = 4,943) were 65 years and older, while 7.1 percent (n = 767) were 75 years and older. There was a higher relative risk (CE versus placebo) of stroke in women less than 75 years of age compared to women 75 years and over.

              In the estrogen-alone substudy of WHIMS, a substudy of WHI, a population of 2,947 hysterectomized women, aged 65 to 79 years, was randomized to CE (0.625 per day) or placebo. After an average follow-up of 5.2 years, the relative risk (CE vs. placebo) of probable dementia was 1.49 (95% CI 0.83-2.66). The absolute risk of developing probable dementia with estrogen alone was 37 vs. 25 cases per 10,000 women-years with placebo.

              Of the total number of subjects in the estrogen-plus-progestin substudy of the WHI study, 44 percent (n = 7,320) were 65-74 years of age, while 6.6 percent (n = 1,095) were 75 years and older. There was a higher relative risk (CE/MPA versus placebo) of non-fatal stroke and invasive breast cancer in women 75 and older compared to women less than 75 years of age. In women greater than 75, the increased risk of non-fatal stroke and invasive breast cancer observed in the estrogen-plus-progestin combination group compared to the placebo group was 75 vs. 24 per 10,000 women-years and 52 vs. 12 per 10,000 women-years, respectively.

              In the estrogen-plus-progestin substudy of WHIMS, a population of 4,532 postmenopausal women, aged 65 to 79 years, was randomized to CE/MPA (CE 0.625 mg/2.5 mg). In the estrogen-plus-progestin group, after an average follow-up of 4 years, the relative risk (CE/MPA versus placebo) of probable dementia was 2.05 (95% CI 1.21-3.48). The absolute risk of developing probable dementia with CE/MPA was 45 vs. 22 cases per 10,000 women-years with placebo.

              Seventy-nine percent of the cases of probable dementia occurred in women that were older than 70 for the CE group, and 82 percent of the cases of probable dementia occurred in women who were older than 70 in the CE/MPA group. The most common classification of probable dementia in both the treatment groups and placebo groups was Alzheimer’s disease.

              When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95% CI 1.19-2.60). Since both substudies were conducted in women aged 65 to 79 years, it is unknown whether these findings apply to younger postmenopausal women. (See and .)


              What are the side effects of ENJUVIA?

              See and .

              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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

              In a 12-week clinical trial, 209 postmenopausal women with vasomotor symptoms were treated with ENJUVIA. Adverse events that occurred in the study at a rate greater than or equal to 5% and greater than placebo, regardless of relationship to study drug, are summarized in .

               

              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). The only adverse event that occurred at a rate of >5% was headache; seven patients (4.55%) with ENJUVIA and twelve patients (7.69%) with placebo.

              The following additional adverse reactions have been reported with estrogen and/or progestin therapy:

              Table 8. ENJUVIA Tablets – Number (%) of Patients Reporting Aderse Events* with ≥ 5% Occurrence Rate by Body System
              Body System/Adverse Event* n=68n=72n=69n=72
              Number of Patients in Safety Sample (%)68 (100)72 (100)69 (100)72 (100)
              Number of Patients with Adverse Events (%)49 (72)55 (76)56 (81)51 (71)
              Number of Patients without Adverse Events (%)19 (28)17 (24)13 (19)21 (29)
              Body as a Whole
                 Abdominal Pain3 (4)11 (15)3 (4)7 (10)
                 Accidental Injury6 (8)2 (3)3 (4)5 (7)
                 Flu Syndrome4 (6)3 (4)5 (7)3 (4)
                 Headache10 (15)18 (25)11 (16)15 (21)
                 Pain10 (15)14 (19)7 (10)6 (8)
              Digestive System
                 Flatulence3 (4)5 (7)3 (4)2 (3)
                 Nausea5 (7)7 (10)8 (12)6 (8)
              Nervous System
                 Dizziness5 (7)3 (4)1 (1)3 (4)
                 Paresthesia04 (6)1 (1)0
              Respiratory System
                 Bronchitis03 (4)5 (7)3 (4)
                 Rhinitis3 (4)4 (6)5 (7)4 (6)
                 Sinusitis2 (3)3 (4)5 (7)2 (3)
              Urogenital System
                 Breast Pain09 (12)10 (14)3 (4)
                 Dysmenorrhea1 (2)6 (8)1 (1)2 (3)
                 Vaginitis1 (2)5 (7)2 (3)3 (4)


              Genitourinary system

              Breasts

              Cardiovascular

              Gastrointestinal

              Skin

              Eyes

              Central Nervous System

              Miscellaneous


              What should I look out for while using ENJUVIA?

              ENJUVIA tablets should not be used in women with any of the following conditions:

              See .


              What might happen if I take too much ENJUVIA?

              Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.


              How should I store and handle ENJUVIA?

              Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010ENJUVIA®(synthetic conjugated estrogens, B) Tablets0.3 mg:The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of:The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of:0.9 mg:The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Keep this and all drugs out of the reach of children.Dispense in a tight container with a child-resistant closure.Pharmacist: Include one “Patient Information” leaflet with each prescription.Iss. 3/2010


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              Clinical Information

              Chemical Structure

              No Image found
              Clinical Pharmacology

              Synthetic conjugated estrogens, B are soluble in water and are well absorbed from the gastrointestinal tract after release from the drug formulation. ENJUVIA tablets release synthetic conjugated estrogens, B slowly over a period of several hours. and summarize the mean pharmacokinetic parameters for unconjugated (free) and conjugated (total) estrogens following single administration of two 0.625 mg tablets to 21 healthy postmenopausal women under fasting conditions. The effect of food on the bioavailability of synthetic conjugated estrogens, B following administration of ENJUVIA tablets has not been studied. However, the presence of food did not significantly affect the pharmacokinetics of a similar formulation of synthetic conjugated estrogens, B.

              Non-Clinical Toxicology
              ENJUVIA tablets should not be used in women with any of the following conditions:

              See .

              The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

              Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

              See and .

              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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

              In a 12-week clinical trial, 209 postmenopausal women with vasomotor symptoms were treated with ENJUVIA. Adverse events that occurred in the study at a rate greater than or equal to 5% and greater than placebo, regardless of relationship to study drug, are summarized in .

               

              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). The only adverse event that occurred at a rate of >5% was headache; seven patients (4.55%) with ENJUVIA and twelve patients (7.69%) with placebo.

              The following additional adverse reactions have been reported with estrogen and/or progestin therapy:

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              Reference

              This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
              "https://dailymed.nlm.nih.gov/dailymed/"

              While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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              Professional

              Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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              Interactions

              Interactions

              A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).