VAGIFEM Dosage & Rx Info | Uses, Side Effects

Vagifem Generic Name & Formulations

Legal Class

General Description

Estradiol (as hemihydrate) 10mcg; vaginal inserts.

Pharmacological Class

Estrogen.

How Supplied

Vaginal inserts—8, 18 (w. applicators)

Storage

Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Do not refrigerate.

Manufacturer

Novo Nordisk

Generic Availability

YES

Mechanism of Action

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and FSH, through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

Vagifem Indications

Indications

Atrophic vaginitis due to menopause.

Vagifem Dosage and Administration

Adult

Use lowest effective dose for the shortest duration. 1 insert intravaginally once daily for 2 weeks, then 1 insert twice weekly. Reevaluate periodically.

Children

Not indicated.

Vagifem Contraindications

Contraindications

Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease (eg, stroke, MI) or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Vagifem Boxed Warnings

Boxed Warning

Endometrial cancer. Cardiovascular disorders. Breast cancer. Probable dementia.

Vagifem Warnings/Precautions

Warnings/Precautions

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, stroke, MI, VTE); discontinue if these occur or are suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Preexisting hypertriglyceridemia. History of cholestatic jaundice. Discontinue if pancreatitis, hypercalcemia, or recurrence of cholestatic jaundice occurs. Monitor thyroid function. Monitor conditions that may predispose to fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Pregnancy: not indicated. Nursing mothers.

Vagifem Pharmacokinetics

Distribution

Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in blood largely bound to SHBG and albumin.

Metabolism

Hepatic.

Elimination

Renal.

Vagifem Interactions

Interactions

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). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

Vagifem Adverse Reactions

Adverse Reactions

See full labeling. Upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection, diarrhea; thromboembolic disorders, neoplasms.

Vagifem Clinical Trials

See Literature

Vagifem Note

Not Applicable

Vagifem Patient Counseling