Important
Safety Information
Estrasorb is indicated for the treatment of
moderate to severe vasomotor symptoms associated with menopause. Estrasorb should
not be used in women with any of the following conditions:
undiagnosed abnormal genital bleeding; known, suspected, or
history of cancer of the breast; known or suspected estrogen-dependent
neoplasia; active deep-vein thrombosis, pulmonary embolism
or history of these conditions; active or recent (eg, within
the past year) arterial thromboembolic disease (eg, stroke,
myocardial infarction); liver dysfunction or disease. Estrasorb should
not be used in patients with known hypersensitivity to its
ingredients; known or suspected pregnancy. There is no indication
for Estrasorb in pregnancy. There appears to be little
or no increased risk of birth defects in women who have used
estrogens and progestins from oral contraceptives inadvertently
during early pregnancy (See PRECAUTIONS in full Prescribing
Information).
The most frequently reported adverse events (≥5% and more frequently
than placebo) in clinical trials for Estrasorb were: Infection;
Sinusitis; Pruritus; Breast pain; and Endometrial disorder. |
Important
safety information you should know about estrogen.
Estrogens increase the chances of getting cancer of the uterus. Report
any unusual vaginal bleeding right away while you are using Estrasorb.
Vaginal bleeding after menopause may be a warning sign of cancer of
the uterus (womb). Your healthcare professional should check any unusual
vaginal bleeding to find out the cause.
Do not use estrogens with
or without progestins to prevent heart disease, heart
attacks, strokes, or dementia.
Using estrogens with or without progestins may increase your chances
of getting heart attacks, strokes, breast cancer, and blood clots.
Using estrogens with or without progestins may increase your risk of
dementia, based on a study of women aged 65 years or older. You and
your healthcare professional should talk regularly about whether you
still need treatment with Estrasorb. |
|
Please see Full
Prescribing Information for Estrasorb.
For medical questions and to report adverse
events, please call 1-866-230-0375.
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Copyright © 2007 Esprit Pharma. Estrasorb is a registered
trademark of Novavax, Inc. |
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