ESTRADIOL film, extended release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)

Disponibbli minn:

Noven Therapeutics, LLC

Rotta amministrattiva:

TRANSDERMAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

ESTRADIOL TRANSDERMAL SYSTEM is indicated for: Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. ESTRADIOL TRANSDERMAL SYSTEM is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding [See Warnings and Precautions (5.2)] . - Breast cancer or a history of breast cancer [See Warnings and Precautions (5.2)] . - Estrogen-dependent neoplasia [See Warnings and Precautions (5.2)] . - Active DVT, PE, or a history of these conditions [See Warnings and Precautions (5.1)] . - Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [See Warnings and Precautions (5.1)] . - Known anaphylactic reaction or angioedema or hypersensitivity to ESTRADIOL TRANSDERMAL SYSTEM - Hepatic impairment or disease - Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Risk Summary ESTRADIOL TRANSDERMAL SYSTEM is not indicated for use in pregnancy. There are no data with the use of ESTRADIOL TRANSDERMAL SYSTEM in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary Estrogens are present in human milk and can reduce milk production in breast-feeding women. This reduction can occur at any time but is less likely to occur once breast-feeding is well established. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ESTRADIOL TRANSDERMAL SYSTEM and any potential adverse effects on the breastfed child from ESTRADIOL TRANSDERMAL SYSTEM or from the underlying maternal condition. ESTRADIOL TRANSDERMAL SYSTEM is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population. There have not been sufficient numbers of geriatric women involved in clinical studies utilizing ESTRADIOL TRANSDERMAL SYSTEM to determine whether those over 65 years of age differ from younger subjects in their response to ESTRADIOL TRANSDERMAL SYSTEM. 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 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 (14.3)] . INSTRUCTIONS FOR USE ESTRADIOL TRANSDERMAL SYSTEM Read this PATIENT INFORMATION before you start using ESTRADIOL TRANSDERMAL SYSTEM and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment. You will need the following supplies (See Figure A) Figure A Step 1: Pick the days you will change your patch. - You will need to change your patch 2 times a week or every 3 to 4 days. Use the calendar printed inside your carton to choose the 2 days you will change your patch (See Figure B). - Remember to change your patch on the same 2 days you marked on your calendar. If you forget to change your patch on the correct date, apply a new patch as soon as you remember, and continue to follow your original schedule Figure B Step 2. Remove the ESTRADIOL TRANSDERMAL SYSTEM patch from the pouch. - Remove the patch from its protective pouch by tearing at the notch (do not use scissors, See Figure C). - Do not remove your patch from the protective pouch until you are ready to apply it Figure C Step 3. Remove half of the adhesive liner (See Figure D). Figure D Step 4. Placing the patch on your skin. - Hold the part of the patch that still has the adhesive liner on it - Avoid touching the sticky half of the patch with your fingers - Apply the exposed sticky half of the patch to 1 of the areas of skin shown below (See Figures E and F) Note: - Avoid the waistline, since clothing and belts may cause the patch to be rubbed off - Do not apply the patch to your breasts - Only apply the patch to skin that is clean, dry, and free of any powder, oil, or lotion - You should not apply the patch to injured, burned, or irritated skin, or areas with skin conditions (such as birth marks, tattoos, or that is very hairy) Step 5: Press the patch firmly onto your skin. - Remove the remaining half of the adhesive liner and press the entire patch into place with the palm of your hand for 10 seconds - Rub the edges of the patch with your fingers to make sure that it will stick to your skin (See Figure G) Figure G Note: - Showering will not cause your patch to fall off - If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area (See Figures D and E) and continue to follow your original placement schedule - If you stop using your ESTRADIOL TRANSDERMAL SYSTEM patch or forget to apply a new patch as scheduled, you may have spotting, or bleeding, and recurrence of symptoms Step 6: Throwing away your used patch. - When it is time to change your patch, remove the old patch before you apply a new patch - To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Distributed by: Grove Pharmaceuticals Miami, FL 33186 Approved 02/2024 Vivelle® is a registered trademark of Novartis Corporation. 102631-3

Sommarju tal-prodott:

ESTRADIOL TRANSDERMAL SYSTEM, 0.025 mg per day - each 1.65 cm2 system contains 0.41 mg of estradiol USP for nominal* delivery of 0.025 mg of estradiol per day. Patient Calendar Pack of 8 Systems…………………………………..NDC 68968-3425-8 ESTRADIOL TRANSDERMAL SYSTEM, 0.0375 mg per day - each 2.48 cm2 system contains 0.62 mg of estradiol USP for nominal* delivery of 0.0375 mg of estradiol per day. Patient Calendar Pack of 8 Systems…………………………………..NDC 68968-3437-8 ESTRADIOL TRANSDERMAL SYSTEM, 0.05 mg per day - each 3.3 cm2 system contains 0.83 mg of estradiol USP for nominal* delivery of 0.05 mg of estradiol per day. Patient Calendar Pack of 8 Systems………………………………….NDC 68968-3450-8 ESTRADIOL TRANSDERMAL SYSTEM, 0.075 mg per day - each 4.95 cm2 system contains 1.24 mg of estradiol USP for nominal* delivery of 0.075 mg of estradiol per day. Patient Calendar Pack of 8 Systems………………………………….NDC 68968-3475-8 ESTRADIOL TRANSDERMAL SYSTEM, 0.1 mg per day - each 6.6 cm2 system contains 1.65 mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol per day. Patient Calendar Pack of 8 Systems………………………………….NDC 68968-3410-8 *See Description Store at room temperature 68°F to 77°F (20°C to 25°C); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature ] Do not store unpouched. Apply immediately upon removal from the protective pouch. Used transdermal systems still contain active hormone. To discard, fold the sticky side of the transdermal system together, place it in a sturdy child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.

L-istatus ta 'awtorizzazzjoni:

New Drug Application Authorized Generic

Karatteristiċi tal-prodott

ESTRADIOL- ESTRADIOL FILM, EXTENDED RELEASE
NOVEN THERAPEUTICS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL
TRANSDERMAL SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ESTRADIOL TRANSDERMAL SYSTEM
ESTRADIOL TRANSDERMAL SYSTEM
INITIAL U.S. APPROVAL: 1975
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE
DEMENTIA, AND BREAST CANCER
_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)
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)
DO NOT USE ESTROGEN-ALONE THERAPY FOR THE PREVENTION OF CARDIOVASCULAR
DISEASE OR
DEMENTIA (5.1, 5.3)
ESTROGEN PLUS PROGESTIN THERAPY
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 SUBSTUDY 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)
DO NOT USE ESTROGEN PLUS PROGESTOGEN THERAPY FOR THE PREVENTION OF
CARDIOVASCULAR
DISEASE OR DEMENTIA (5.1, 5.3)
RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms (5.2)
02/2024
INDICATIONS AND USAGE
ESTRADIOL TRANSDERMAL SYSTEM is an estrogen indicated for:
Treatment of moderate to severe vasomotor symptoms due to menopause
(1.1)
Prevention of postmenopausal osteoporosis (1.2)
Limitation of Use
When prescribing solely for the treatment of postmenopausal
osteoporosis, first consider the use of
non-estrogen medications. Consider estrogen t