CLIMARA PRO- estradiol and levonorgestrel patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 0.045 mg in 1 d

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Climara Pro is indicated for: 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 Pro is contraindicated in women with any of the following conditions: Climara Pro is not indicated for use in pregnancy. There are no data with the use of Climara Pro 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 plus progestogens 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 Pro and any potential adverse effects on the breastfed child from Climara Pro or from the underlying maternal condition. Climara Pro 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 Climara Pro to determine whether those over 65 years of age differ from younger subjects in their response to Climara Pro. 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 (14.5)] . 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 (14.5)] 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 plus progestin or estrogen-alone when compared to placebo [see Warnings and Precautions (5.3), and Clinical Studies (14.6)] . 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 (14.6)] .

Product summary:

Climara Pro (estradiol/levonorgestrel transdermal system) 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel – each 22 cm2 system contains 4.4 mg of estradiol and 1.39 mg of levonorgestrel. NDC 50419-491-04 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 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 hormones. 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 PRO- ESTRADIOL AND LEVONORGESTREL 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 PRO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLIMARA PRO.
CLIMARA PRO (ESTRADIOL/LEVONORGESTREL TRANSDERMAL SYSTEM)
INITIAL U.S. APPROVAL: 1975
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER,
AND ENDOMETRIAL CANCER
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ESTROGEN PLUS PROGESTIN THERAPY
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ESTROGEN-ALONE THERAPY
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RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 12/2023
INDICATIONS AND USAGE
Climara Pro is an estrogen plus progestin indicated in a woman with a
uterus for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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®
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN PLUS PROGESTIN SUBSTUDY
REPORTED
INCREASED RISKS OF STROKE, DEEP VEIN THROMBOSIS (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 WHI MEMORY STUDY (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)
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO
USES UNOPPOSED ESTROGENS (5.2)
THE WHI ESTROGEN-ALONE SUBSTUDY REPORTED INCREASED RISKS OF STROKE AND
DVT (5.1)
THE 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)
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
(1.1)
Prevention of Postmenopausal Osteoporosis (1.2)
Limitations of Us