Frequently asked questions about FASLODEX
These frequently asked questions are provided as a service by AstraZeneca Pharmaceuticals LP, the maker of FASLODEX. They are not a substitute for a full discussion with your doctor about your condition and its treatment.
Q: What is FASLODEX?
A: FASLODEX is a hormonal treatment for hormone receptor-positive metastatic breast cancer in postmenopausal patients whose disease has returned or progressed following antiestrogen therapy. FASLODEX is described as an estrogen receptor antagonist.
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Q: What is an estrogen receptor antagonist?
A: An estrogen receptor antagonist is a drug that blocks the stimulating effects of estrogen on a tumor cell.
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Q: Do postmenopausal women still produce estrogen?
A: Yes. Although postmenopausal women no longer produce estrogen in the ovaries, low levels of estrogen are still produced. This estrogen is converted from another hormone produced in the adrenal glands.
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Q: How does FASLODEX work?
A: The breast cancer cells of many women diagnosed with breast cancer will have receptors for estrogen and/or progesterone. When they do, the breast cancer is said to be hormone receptor-positive. When breast cancers are estrogen receptor positive, estrogen may contribute to the growth and spread of the cancer.
FASLODEX is a hormonal therapy that works by binding to estrogen receptors. In doing so, FASLODEX can block the effect estrogen has on the cancer cells. FASLODEX causes the estrogen receptor to change shape and not work as well. In addition, FASLODEX causes a decrease in the number of estrogen receptors.
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Q: Why should appropriate patients be treated with FASLODEX?
A: In a clinical trial, FASLODEX was found to be effective when tamoxifen no longer worked. FASLODEX 500 mg has a comparable side effect profile to the 250-mg dose and provides a reduction in the risk of disease progression.
Your doctor will know if FASLODEX is right for you.
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Q: How has FASLODEX been studied and tested?
A: In a clinical study, the 500-mg dose of FASLODEX was compared to the original 250-mg dose, among 736 postmenopausal women with hormone receptor-positive metastatic breast cancer. In these women, the disease had returned or progressed on antiestrogen medicine or after previous treatment with antiestrogen medicine. The patients were randomly assigned to receive FASLODEX 500 mg or FASLODEX 250 mg. The study established that the 500-mg dose reduced the risk of disease progression by 20% compared to the 250-mg dose. The study also established that the side effect profile of the 500-mg dose was comparable to that of the 250-mg dose.
The safety and effectiveness of FASLODEX was previously established in clinical trials comparing FASLODEX 250 mg with ARIMIDEX® (anastrozole) Tablets, another hormonal treatment. These studies included postmenopausal women whose metastatic breast cancer recurred or progressed after previous treatment with hormonal therapy.
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Q: Should FASLODEX be used by everyone with breast cancer?
A: No. FASLODEX is only approved to treat hormone receptor-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with antiestrogen medicine. Your doctor will know if FASLODEX is right for you.
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Q: Is there anyone who shouldn't take FASLODEX?
FASLODEX should be taken only by postmenopausal women. FASLODEX should not be taken by anyone who has had an allergic reaction to any of the ingredients. You should tell your doctor if you have a blood disorder, are on blood thinners, or have liver problems. FASLODEX can harm your unborn baby. Talk to your doctor about how to prevent pregnancy while receiving FASLODEX. Tell your doctor right away if you become pregnant or think you are pregnant while receiving FASLODEX.
Tell your healthcare provider about any medical conditions you have before taking FASLODEX.
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Q: How is FASLODEX given?
A: FASLODEX is given on days 1, 15, 29 and once monthly thereafter, as two intramuscular (IM) injections administered by your health care professional. After your first dose of two injections, you will get FASLODEX again in two weeks (the day 15 dose), again in another two weeks (about a month after your first dose), and then monthly thereafter.
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Q: Does the injection site hurt after administration?
A: Injection site pain was reported in 11.6% of patients receiving FASLODEX.
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Q: Are any special tests required while on FASLODEX?
A: No. FASLODEX does not require any specific laboratory testing. Of course, your doctor will continue to check you at regular intervals and decide what is appropriate for you.
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Q: Does FASLODEX have any side effects?
A: In a clinical trial, commonly reported side effects seen with FASLODEX were injection site pain, nausea, and muscle, joint, and bone pain. In this study, 0.6% of patients receiving FASLODEX 500 mg and 0.8% of patients receiving FASLODEX 250 mg withdrew from treatment due to side effects. If you are concerned about any symptoms you may be experiencing, you should contact your doctor immediately. Learn more about possible side effects.
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Q: Can FASLODEX be taken with other medications?
A: There are no known drug-drug interactions. However, because FASLODEX is given as an injection into the muscle, it should not be used in patients with certain blood disorders or those receiving anticoagulants (sometimes called blood thinners).
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Q: Is FASLODEX covered by insurance?
A: Because FASLODEX is an injectable medicine that must be administered by a health care professional, coverage is determined by your medical plan (the insurance that covers medical procedures and office visits), and not your prescription plan.
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