Imvexxy (Estradiol Vaginal Inserts)

Uses of Imvexxy

Imvexxy is a vaginal estrogen treatment option for moderate to severe mdyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Vulvar and vaginal atrophy may also be known as vulvovaginal atrophy, atrophic vaginitis, or vaginal atrophy.

Imvexxy is a bio-identical, softgel vaginal insert that offers an applicator-free experience with mess-free administration, no dose preparation, and any time of day dosing, which may help support patient compliance. Imvexxy is the only ultra-low-dose vaginal estradiol available in both 4-mcg and 10-mcg doses

Precautions and Warnings

Risks from systemic absorption. Imvexxy is intended only for vaginal administration. Systemic absorption may occur with the use of Imvexxy.

Cardiovascular disorders, malignant neoplasms, and probable dementia. Please refer to Boxed Warning for endometrial cancer, cardiovascular disorders, probable dementia, and breast cancer.

The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.

The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.

Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, elevated blood pressure, severe hypertriglyceridemia, cholestatic jaundice, fluid retention, and hypocalcemia in women with hypoparathyroidism.

Estrogen therapy may exacerbate: hypothyroidism, endometriosis, hereditary angioedema, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas, and should be used with caution in women with these conditions.

Women on thyroid replacement therapy should have their thyroid function monitored.

Dosage

To start using Imvexxy, patients insert 1 softgel vaginal insert with their fingers into the vagina, smaller end up, once daily for 2 weeks.

For the maintenance dose of Imvexxy, patients insert 1 softgel vaginal insert twice weekly every 3 to 4 days (for example, Monday and Thursday) for as long as they use Imvexxy,

Side Effects

Common Side Effects:

• Headache
• Back Pain
• Breast pain and tenderness
• Abnormal vaginal bleeding or spotting
• Itching, irritation, or burning sensation in the vagina
• Stomach cramps, bloating, nausea, vomiting, or diarrhea
• Hair loss
• Fluid retention (edema)
• Vaginal yeast infection