Frequently asked questions about FASLODEX
Q: What is FASLODEX?
A: FASLODEX is a hormonal treatment therapy 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 effect of estrogen on a tumor cell.
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Q: Do I still produce estrogen if I am postmenopausal?
A: Yes. Although postmenopausal women no longer produce estrogen in the ovaries, low levels of estrogen are still produced by other organs, such as the adrenal glands.
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Q: How does FASLODEX work?
A: FASLODEX works by binding with and downregulating estrogen receptors on the cell. This reduces estrogen binding to the estrogen receptor and inhibits its activity.
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Q: Why should I be treated with FASLODEX?
A: In clinical trials, FASLODEX was found to be effective when tamoxifen no longer worked. Also, FASLODEX is given as a monthly injection, so you don't have to remember to take a pill each day.
Your doctor will know if FASLODEX is right for you.
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Q: How has FASLODEX been studied?
A: FASLODEX was evaluated in two international clinical trials involving a total of 851 postmenopausal women with metastatic breast cancer whose disease had returned or progressed following previous treatment with an antiestrogen, which was usually tamoxifen. The women in the studies were randomly assigned to receive either FASLODEX or anastrozole, another hormonal breast cancer treatment. These trials established the safety and effectiveness of FASLODEX in this setting. The results showed that FASLODEX was effective when tamoxifen no longer worked.
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Q: Should FASLODEX be used by everyone with breast cancer?
A: No. FASLODEX has been studied only in postmenopausal women with hormone receptor-positive metastatic breast cancer whose cancer had returned or progressed following antiestrogen therapy such as tamoxifen. FASLODEX is recommended for patients with hormone-sensitive breast cancer. Your doctor will know if FASLODEX is right for you.
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Q: Is there anyone who shouldn't take FASLODEX?
A: FASLODEX should be taken only by postmenopausal women. FASLODEX may cause fetal harm when given to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving FASLODEX. Because FASLODEX is administered intramuscularly, it should not be used in patients with certain blood disorders or in patients receiving anticoagulants (sometimes called blood thinners, for example, Coumadin® [warfarin sodium]*).
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Q: How is FASLODEX given?
A: FASLODEX is given once a month as an intramuscular injection into the buttock. During your monthly visit, the 250-mg dose can be given as either one or two injections.
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Q: Who will give the FASLODEX injection?
A: FASLODEX will most likely be given to you by a nurse in the doctor's office or clinic. The injection doesn't take long. Your doctor and nurse will decide whether your dose of FASLODEX will be given in one injection or two injections during your monthly visit.
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Q: Does the injection hurt?
A: Injection site reactions with mild, transient pain and inflammation were reported in 7% of patients.
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Q: Will I need any special tests 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 clinical studies, the most commonly reported side effects seen with FASLODEX were nausea, vomiting, constipation, diarrhea, abdominal pain, headache, back pain, hot flashes, and sore throat. Injection site pain and reactions have been reported; however, they were usually mild in nature. Be sure to contact your doctor if you have any concerns.
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Q: Is treatment with FASLODEX difficult to tolerate?
A: In clinical trials, 2.8% of patients receiving FASLODEX withdrew from treatment due to side effects.
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Q: Will I gain weight while on FASLODEX?
A: In clinical trials, 0.9% of patients treated with FASLODEX experienced weight gain.
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Q: Can I take FASLODEX with my other medications?
A: 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, such as Coumadin® [warfarin sodium]*). Please be sure to let your doctor know about all the medications (prescription, over-the-counter, and herbal supplements) you currently take. Also, check with your doctor before starting any other medication.
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Q: Will FASLODEX be 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. If you cannot confirm coverage through your health plan or doctor's office, or if you have no coverage, please call the AZ&Me Prescription Savings Program at 1-800-AZandMe (1-800-292-6363). Be sure to have any insurance information available when you call.
If you have any concerns about treatment with FASLODEX, please discuss them with your doctor or nurse.
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.
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*Coumadin is a registered trademark of Bristol-Myers Squibb Company.