Generic Name and Formulations:
Estradiol (as hemihydrate) 10mcg; vaginal inserts.
Indications for VAGIFEM:
Atrophic vaginitis due to menopause.
1 insert intravaginally once daily for 2 weeks, then 1 insert twice weekly. Reevaluate periodically.
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 (eg, stroke, MI) or a history of these conditions. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known liver impairment or disease. Known angioedema. Known or suspected pregnancy (Cat.X).
See full labeling. Endometrial hyperplasia. Gallbladder disease. Do initial complete physical and repeat annually (include BP, mammogram, Pap smear). Severely atrophic vaginal mucosa or other trauma risk. Familial hyperlipoproteinemia. Discontinue if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs, and at least 4–6 weeks before surgery associated with thromboembolism. Monitor thyroid function. Hereditary angioedema. Nursing mothers.
May be antagonized by CYP3A4 inducers (eg, St. John's Wort, phenobarbital, carbamazepine, rifampin). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice).
See full labeling. Upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection, diarrhea; increased risk of gallbladder disease, thromboembolic disorders.
Vaginal inserts—8, 18 (w. applicators)