Estradiol (Estrogen) Transdermal System Patch 0.0375 MG/DAY — 8 PACK — Generic for Vivelle Dot and Minivelle — Sandoz Pharma

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: 1996

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER

See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

Estrogen Plus Progestin Therapy

Recent Major Changes

Warnings and Precautions, Malignant Neoplasms (5.2) 11/2023

Indications And Usage

Estradiol transdermal system is an estrogen indicated for:

Limitations of Use

When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products.

Limitations 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.

Dosage And Administration

Dosage Forms And Strengths

Transdermal system: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (3)

Contraindications

Warnings And Precautions

• , Malignant Neoplasms (5.2) 11/2023 INDICATIONS AND USAGE Estradiol transdermal system is an estrogen indicated for:
• 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 vaginal atrophy, first consider the use of topical vaginal products.
• Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure (1.3)
• Prevention of postmenopausal osteoporosis (1.4) Limitations 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. DOSAGE AND ADMINISTRATION
• Start therapy with estradiol transdermal system 0.0375 mg/day applied to the skin twice weekly for the treatment of moderate to severe vasomotor symptoms due to menopause or moderate to severe symptoms of vulvar and vaginal atrophy symptoms due to menopause. Dosage adjustment should be guided by the clinical response (2.1, 2.2, 2.3)
• Start therapy with estradiol transdermal system 0.025 mg/day for the prevention of postmenopausal osteoporosis (2.4)
• Place estradiol transdermal system on a clean, dry area of the lower abdomen or buttocks. Do not apply estradiol transdermal system to the breasts (2.5) DOSAGE FORMS AND STRENGTHS Transdermal system: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (3) CONTRAINDICATIONS

• , Malignant Neoplasms (5.2) 11/2023 INDICATIONS AND USAGE Estradiol transdermal system is an estrogen indicated for:
• 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 vaginal atrophy, first consider the use of topical vaginal products.
• Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure (1.3)
• Prevention of postmenopausal osteoporosis (1.4) Limitations 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. DOSAGE AND ADMINISTRATION
• Start therapy with estradiol transdermal system 0.0375 mg/day applied to the skin twice weekly for the treatment of moderate to severe vasomotor symptoms due to menopause or moderate to severe symptoms of vulvar and vaginal atrophy symptoms due to menopause. Dosage adjustment should be guided by the clinical response (2.1, 2.2, 2.3)
• Start therapy with estradiol transdermal system 0.025 mg/day for the prevention of postmenopausal osteoporosis (2.4)
• Place estradiol transdermal system on a clean, dry area of the lower abdomen or buttocks. Do not apply estradiol transdermal system to the breasts (2.5) DOSAGE FORMS AND STRENGTHS Transdermal system: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (3) CONTRAINDICATIONS

Adverse Reactions

The most common adverse reactions (≥10%) with estradiol are: headache, breast tenderness, nasopharyngitis, sinusitis, sinus headache, upper respiratory tract infection, back pain, depression, and irregular vaginal bleeding or spotting. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration. (7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2024