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

These highlights do not include all the information needed to use DOTTI safely and effectively. See full prescribing information for DOTTI.

DOTTI® (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

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 developing 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 developing 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) 11/2023

Indications And Usage

DOTTI 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 DOTTI 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 DOTTI 0.025 mg/day for the prevention of postmenopausal osteoporosis (2.4)

Place DOTTI on a clean, dry area of the lower abdomen or buttocks. Do not apply DOTTI to the breasts (2.5)

Dosage Forms And Strengths

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

Contraindications

Undiagnosed abnormal genital bleeding (4, 5.2)

Breast cancer or a history of breast cancer (4, 5.2)

Estrogen-dependent neoplasia (4, 5.2)

Active DVT, PE or a history of these conditions (4, 5.1)

Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.1)

Known anaphylactic reaction, or angioedema, or hypersensitivity with DOTTI (4, 5.15)

Hepatic impairment or disease (4, 5.10)

Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (4)

Warnings And Precautions

• , Malignant Neoplasms (5.2) 11/2023 INDICATIONS AND USAGE DOTTI 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 DOTTI 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 DOTTI 0.025 mg/day for the prevention of postmenopausal osteoporosis (2.4)
• Place DOTTI on a clean, dry area of the lower abdomen or buttocks. Do not apply DOTTI to the breasts (2.5) DOSAGE FORMS AND STRENGTHS Transdermal system, USP: 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 DOTTI 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 DOTTI 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 DOTTI 0.025 mg/day for the prevention of postmenopausal osteoporosis (2.4)
• Place DOTTI on a clean, dry area of the lower abdomen or buttocks. Do not apply DOTTI to the breasts (2.5) DOSAGE FORMS AND STRENGTHS Transdermal system, USP: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (3) CONTRAINDICATIONS

Estrogens increase the risk of gallbladder disease (5.4)

Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.5, 5.6, 5.9, 5.10)

Monitor thyroid function in women on thyroid replacement therapy (5.11, 5.18)

Adverse Reactions

The most common adverse reactions (≥10%) with DOTTI 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 Amneal Pharmaceuticals at 1-877-835-5472 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: 5/2024