CLIMARA- estradiol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 0.025 mg in 1 d

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Climara is contraindicated in women with any of the following conditions: Climara is not indicated for use in pregnancy. There are no data with the use of Climara 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. 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 Climara and any potential adverse effects on the breastfed child from Climara or from the underlying maternal condition. In general, Climara is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population. If estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone metabolism and effects on epiphyseal centers is recommended during estrogen administration. There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Climara to determine whether those over 65 years of age differ from younger subjects in their response to Climara. 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)] . 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)] .

Product summary:

Climara (estradiol transdermal system), 0.025 mg per day — each 6.5 cm2 system contains 2 mg of estradiol USP Individual Carton of 4 systems NDC 50419-454-04 Climara (estradiol transdermal system), 0.0375 mg per day — each 9.375 cm2 system contains 2.85 mg of estradiol USP Individual Carton of 4 systems NDC 50419-456-04 Climara (estradiol transdermal system), 0.05 mg per day — each 12.5 cm2 system contains 3.8 mg of estradiol USP Individual Carton of 4 systems NDC 50419-451-04 Climara (estradiol transdermal system), 0.06 mg per day — each 15 cm2 system contains 4.55 mg of estradiol USP Individual Carton of 4 systems NDC 50419-459-04 Climara (estradiol transdermal system), 0.075 mg per day — each 18.75 cm2 system contains 5.7 mg of estradiol USP Individual Carton of 4 systems NDC 50419-453-04 Climara (estradiol transdermal system), 0.1 mg per day — each 25 cm2 system contains 7.6 mg of estradiol USP Individual Carton of 4 systems NDC 50419-452-04 Store at 20°C to 25°C (66°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not store above 86°F (30°C). 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.

Authorization status:

New Drug Application

Summary of Product characteristics

CLIMARA- ESTRADIOL PATCH
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLIMARA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLIMARA.
CLIMARA® (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
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ESTROGEN PLUS PROGESTIN THERAPY
•
•
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RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS (5.2) 12/2023
INDICATIONS AND USAGE
Climara is an estrogen indicated for:
•
•
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DOSAGE AND ADMINISTRATION
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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)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
STROKE, DVT,
PULMONARY EMBOLISM (PE), 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)
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
(1.1)
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy
due to Menopause (1.2)
Limitations of Use
When prescribing solely for the treatment of moderate to severe
symptoms of vulvar and vagi