FEMARA
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Package:
FILM COATED TABLETS: 30.
Dosage:
1 tablet daily.
Prescribing Restrictions:
Indications:
First-line treatment in postmenopausal women with hormone receptor positive, or in whome hormone receptor status cannot be determined, locally advanced or metastatic breast cancer.
Treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy.
Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
Contra-Indications:
Hypersensitivity to the active substance or to any of the excipients. Premenopausal endocrine status. Pregnancy, lactation. See prescribing information for full details.
Special Precautions:
Close supervision is needed for patients with creatinine clearance <10 ml/minute and patients with severe hepatic impairment (Child-Pugh score C). Caution is advised when driving or using machines. See prescribing information for full details.
Side Effects:
Observed reactions are generally mainly mild or moderate. Hot flushes, nausea, fatigue, anorexia, increased appetite, headache, dizziness. Alopecia, increased sweating, myalgia, bone pain, arthralgia, arthritis, weight increase. See prescribing information for full details.
Drug Interactions:
Clinically relevant interactions with CYP2C19 are unlikely to occur. However, caution should be used with drugs whose disposition is mainly dependent of these isoenzymes and whose therapeutic index is narrow. See prescribing information for full details.
