TherapeuticsMD Announces Multiple Presentations Related to Imvexxy and TX-001HR at the 2018 Annual Meeting of the North American Menopause Society - Seite 3

IMPORTANT SAFETY INFORMATION FOR IMVEXXY

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

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

• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia

• The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)

• 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

 

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia

• The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI)

• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer

• 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

 

CONTRAINDICATIONS

• Imvexxy is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Imvexxy; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

WARNINGS AND PRECAUTIONS