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Why consider FASLODEX

Clinical trial data

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.

Previous clinical trials

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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FASLODEX is a prescription medicine used to treat hormone receptor-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with antiestrogen medicine.

IMPORTANT SAFETY INFORMATION: You should not receive FASLODEX if you have had an allergic reaction to any of the ingredients in FASLODEX. Symptoms of an allergic reaction to FASLODEX may include itching, swelling of your face, lips, tongue, or throat, or trouble breathing.

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Additional Safety Information

Important Safety Information About FASLODEX

You should not receive FASLODEX if you have had an allergic reaction to any of the ingredients in FASLODEX. Symptoms of an allergic reaction to FASLODEX may include itching, swelling of your face, lips, tongue, or throat, or trouble breathing.
Because FASLODEX is administered directly into the muscle, you should tell your doctor if you have a blood disorder or are on anticoagulants (sometimes called blood thinners).
Also tell your doctor if you have liver problems.
Tell your doctor if you are pregnant. 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.
The common side effects were: injection site pain, nausea, muscle, joint, and bone pain, headache, tiredness, hot flashes, vomiting, loss of appetite, weakness, cough, constipation, shortness of breath, and increased liver enzymes.

Approved Use For FASLODEX

FASLODEX is a prescription medicine used to treat hormone receptor-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with antiestrogen medicine.

Prescribing Information, with Patient Information.

Important Safety Information About ARIMIDEX^® (anastrozole) Tablets

Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child. Do not take ARIMIDEX if you are allergic to any of its ingredients.
Based on information from a study in patients with early breast cancer, women with a history of blockages in heart arteries (ischemic heart disease) who take ARIMIDEX may have a slight increase in this type of heart disease compared to similar patients who take tamoxifen.
ARIMIDEX can cause bone softening/weakening (osteoporosis) increasing the chance of fractures. In a clinical study in early breast cancer, there were more fractures (including fractures of the spine, hip, and wrist) with ARIMIDEX (10%) than with tamoxifen (7%).
In a clinical study in early breast cancer, some patients taking ARIMIDEX had an increase in cholesterol. Skin reactions, allergic reactions, and changes in blood tests of liver function have also been reported.
In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include hot flashes, joint symptoms (including arthritis and arthralgia), weakness, mood changes, pain, back pain, sore throat, nausea and vomiting, rash, depression, high blood pressure, osteoporosis, fractures, swelling of arms/legs, insomnia, and headache.
In advanced breast cancer trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, headache, bone pain, increased cough, shortness of breath, sore throat, and swelling of arms and legs. Joint pain/stiffness has been reported in association with the use of ARIMIDEX.
ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies.

Approved Uses for ARIMIDEX

ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

Prescribing Information, with Patient Information.

If you would like additional information regarding AstraZeneca products, please contact the Information Center at AstraZeneca in the United States at 1-800-236-9933, Monday through Friday, 8 AM to 6 PM ET, excluding holidays.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

This product information is intended for US audiences only.

FASLODEX and ARIMIDEX are registered trademarks of the AstraZeneca group of companies.

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