IMVEXXY

AbsorptionEstrogen drug products are well absorbed through the skin, mucous membranes, and the gastrointestinal tract. The vaginal delivery of estrogens circumvents first-pass metabolism. In a multicenter, double-blind placebo-controlled study of 574 postmenopausal women randomized to placebo, or 4 and 10 mcg of IMVEXXY, a subset of 54 women participated in a pharmacokinetics substudy. Women received 1 vaginal insert daily for the first 2 weeks, followed by 1 insert twice weekly for the followi...

14.1 Effects on Moderate to Severe Dyspareunia in Postmenopausal Women The effectiveness and safety of IMVEXXY on moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause were examined in one placebo-controlled clinical trial. This 12-week, randomized, double-blind, placebo-controlled, parallel-group trial enrollee 574 generally healthy postmenopausal women between 40 to 75 years of age (mean 59 years of age) who at baseline assessment had ≤ 5% superficial cells on a vaginal smear, a vaginal pH > 5.0, and also identified, at baseline, moderate to severe dyspareu...

The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.2) ]. Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.3) ] . The most common adverse reaction with IMVEXXY (incidence ≥ 3% and greater than placebo) is 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 . 6.1 Clinical Tri...

IMVEXXY is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding [see Warning and Precautions (5.3) ]. Breast cancer or a history of breast cancer [see Warnings and Precautions (5.3) ]. Estrogen-dependent neoplasia [see Warnings and Precautions (5.3) ]. Active DVT, PE, or history of these conditions [see Warnings and Precautions (5.2) ]. Active arteri...

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 ) 5.1 Risks from Systemic Absorption IMVEXXY is intended only for vaginal administration. Systemic absorption may occur with the use of IMVEXXY [see Pharmacokinetics (12.3) ]. The warnings, precautions, a...

7 DRUG INTERACTIONS In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resu...