Tumor flare and hypercalcemia
Hot flashes
Endometrial cancer
Many women who take hormonal agents for breast cancer experience some side effects, particularly when they first start treatment. Hot flashes, sweating,
nausea, and vaginal discharge, in addition to other side effects, have been reported in women taking FARESTON®.
A small percentage of women may even experience vaginal bleeding.
In North American clinical trials, the most commonly observed side effects with FARESTON® versus tamoxifen
were hot flashes (35% vs 30%), sweating (20% vs 17%), nausea (14% vs 15%), and vaginal discharge (13% vs 16%), respectively; these side effects occurred with similar severity
and frequency in each treatment group.
During FARESTON® clinical trials involving 1157 patients treated with FARESTON® or tamoxifen, there was a low incidence of serious side effects, including
cardiac events (2.03% vs 2.42%), stroke (3.21% vs 3.28%), and elevated standard liver tests (26.2% vs 23.7%), respectively.
Some patients receiving hormonal treatments, such as FARESTON® or other antiestrogens,
may experience a condition called “tumor flare” when they first start treatment. For reasons that are not completely clear, even though hormonal agents prevent estrogen
from stimulating breast cancer cells, they may cause a slight and temporary increase of tumor size when first administered, particularly in women whose cancer involves bone.
In about 10% of patients receiving hormone therapy, bone pain and redness of the skin may occur in the first weeks
of treatment. You should understand that this condition is temporary and will resolve shortly; it does not mean that your cancer is getting worse. Speak with your physician for
advice on treatment for pain, particularly if pain is severe.
Tumor flare may be associated with increased calcium levels in the blood in a small percentage of patients who begin treatment with hormonal agents. This condition, called hypercalcemia,
requires prompt treatment. Symptoms of hypercalcemia are sleepiness, constipation, frequent urination, and nausea/vomiting. If you experience any of these symptoms, you should
call your physician immediately.
Hot flashes occur when blood vessels in the skin, normally under the control of estrogen, dilate,
causing heat to be lost from the body. This loss of heat is perceived as a hot flash. You may feel chilly right after a hot flash because of this loss of heat.
Clothing may make hot flashes feel worse. Try to wear natural fibers such as cotton because they allow body heat to pass through. To help you sleep, try wearing
cotton nightclothes and using cotton sheets.
Some patients treated with FARESTON® have developed endometrial cancer, but circumstances—such
as short duration of treatment, prior antiestrogen treatment, or premalignant conditions—make it difficult to establish the role of FARESTON®. Please consult with your
physician about risk factors that may increase your risk of developing endometrial cancer.
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