Imvexxy (estradiol) is a bio-identical 17?-estradiol vaginal insert for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause. hese highlights do not include all the information needed to use IMVEXXY safely and effectively. See full prescribing information for IMVEXXY. IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol. Each insert is imprinted in white ink on one side with “04” or “10” corresponding to the insert's dosage strengths.
IMVEXXY (estradiol vaginal inserts), 4 mcg and 10 mcg, are provided in opaque push-through blisters and are packaged in cartons containing either 18 inserts for the starter pack or 8 inserts for the maintenance pack.
IMVEXXY 4 mcg 8 inserts NDC 50261-104-08
IMVEXXY 4 mcg 18 inserts NDC 50261-104-18
IMVEXXY 10 mcg 8 inserts NDC 50261-110-08
IMVEXXY 10 mcg 18 inserts NDC 50261-110-18
Keep out of reach of children. Packages are not child-resistant.
16.2 Storage and Handling
Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.]
IMVEXXY® (estradiol vaginal inserts)
Initial U.S. Approval: 1975
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.3)
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) (5.2)
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 (5.4)
Estrogen Plus Progestin Therapy
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI) (5.2)
The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer (5.3)
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 (5.4)
INDICATIONS AND USAGE
IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1)
DOSAGE AND ADMINISTRATION
IMVEXXY should be administered intravaginally:
1 vaginal insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Monday and Thursday). (2.1)
DOSAGE FORMS AND STRENGTHS
IMVEXXY vaginal inserts contain 4 mcg or 10 mcg estradiol. (3)
Undiagnosed abnormal genital bleeding (4)
Known, suspected, or history of breast cancer (4, 5.3)
Known or suspected estrogen-dependent neoplasia (4, 5.3)
Active DVT, PE, or history of these conditions (4, 5.2)
Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.2)
Known anaphylactic reaction or angioedema with IMVEXXY (4)
Known liver impairment or disease (4, 5.11)
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (4)
WARNINGS AND PRECAUTIONS
Estrogens increase the risk of gallbladder disease (5.5)
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs (5.6, 5.7, 5.10, 5.11)
Monitor thyroid function in women on thyroid replacement hormone therapy (5.12, 5.19)
In a single, prospective, randomized, placebo-controlled, double-blind trial, the most common adverse reaction with IMVEXXY (incidence ?3 percent and greater than placebo) was headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact TherapeuticsMD, Inc. at 1-888-228-0150 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration (7.1)
USE IN SPECIFIC POPULATIONS
Geriatric use: An increased risk of probable dementia in women over 65 years of age was reported in the Women's Health Initiative Memory ancillary studies of the Women's Health Initiative (5.4, 8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.