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Important Information About FASLODEX

FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Important Safety Information About FASLODEX

• FASLODEX is only for postmenopausal women. FASLODEX can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving FASLODEX. (See CONTRAINDICATIONS and WARNINGS sections of full Prescribing Information.)
• Because FASLODEX is administered intramuscularly, it should not be used in patients with bleeding diatheses, thrombocytopenia, or in patients on anticoagulants.
• In clinical trials, the most commonly reported adverse effects seen with FASLODEX, regardless of the investigator’s assessment of causality, were gastrointestinal symptoms (nausea 26.0%, vomiting 13.0%, constipation 12.5%, diarrhea 12.3%, abdominal pain 11.8%), headache 15.4%, back pain 14.4%, hot flashes 17.7%, and pharyngitis 16.1%. Injection site reactions with mild, transient pain and inflammation were reported in 7% of patients (1% of treatments) given a single 5 mL injection and 27% of patients (4.6% of treatments) given 2 x 2.5 mL injections of FASLODEX.

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