Description

Chemical Name: ESTRADIOL (ess-tra-DYE-ole)

VAGIFEM is a form of female hormone called estrogen. It is usually given to women who no longer are able to produce the proper amount of hormone. It is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. VAGIFEM also reduces urgency or irritation of urination.

This product comes with an applicator.

Directions

Some VAGIFEM products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms involving the secretions and surrounding tissues of the vagina. Others are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is placed or applied. Use this medication as directed by your doctor. Read the patient instructions provided with the medication.

Do not change your doses of medication schedule without your doctor's advice.

Cautions

Before patients start taking this medication, they should be aware of important safety information. Please see below for important information:

• This medication has been reported to increase the chance of cancer of the uterus (endometrial cancer). Inform your doctor immediately if you have any unusual vaginal bleeding.
• This medication may also increase your risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogen given in combination with progestin can infrequently cause heart disease (e.g., heart attacks), stroke, serious blood clots (pulmonary embolism and deep venous thrombosis), dementia, and cancer of the breast. Some of these risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, this medication should be used for the shortest possible length of time at the lowest effective dose.
• Also, the risks are greater with estrogen products taken by mouth, absorbed through the skin, or injected because more estrogen gets into the blood. Therefore, if you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina are preferred and should be considered first.
• Treatment with this medication alone does not appear to increase your risk of breast cancer when used for up to 7 years after menopause.
• Products that contain estrogen should not be used to prevent heart disease or dementia.
• If you use this drug for an extended period, you should have a complete physical exam at regular intervals or as directed by your doctor.

Side Effects

VAGIFEM given alone and with another hormone such as progestin for replacement therapy after menopause have sometimes caused rare but very serious side effects. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor.

Common side effects may include:

• nausea, vomiting, loss of appetite
• swollen breasts
• acne or skin color changes
• decreased sex drive, impotence, or difficulty having an orgasm
• migraine headaches or dizziness
• vaginal pain, dryness, or discomfort
• swelling of your ankles or feet
• depression
• changes in your menstrual periods, break-through bleeding

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling
• sudden numbness or weakness, especially on one side of the body
• sudden headache, confusion, problems with vision, speech, or balance
• pain, swelling, warmth, or redness in one or both legs
• abnormal vaginal bleeding
• pain, swelling, or tenderness in your stomach
• jaundice (yellowing of the skin or eyes)
• a lump in your breast