Zuellig Pharma
Concise Prescribing Info
Monotherapy for postmenopausal women w/ estrogen receptor +ve & HER2 -ve if not previously treated w/ endocrine therapy, locally advanced or metastatic breast cancer w/ disease relapse on or after adjuvant endocrine therapy or disease progression on endocrine therapy. In combination w/ ribociclib for postmenopausal women w/ hormone-receptor (HR) +ve, HER2 -ve advanced or metastatic breast cancer as initial therapy or following disease progression. In combination w/ palbociclib for women who have received prior endocrine therapy w/ HR +ve, HER2 -ve locally advanced or metastatic breast cancer.
Dosage/Direction for Use
Adult female including elderly 500 mg at 1 mth interval w/ additional 500-mg dose given 2 wk after initial dose, administered 1 in each buttock as 2 consecutive 5 mL slow IM inj.
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Bleeding diatheses, thrombocytopenia; thromboembolic events; potential risk of osteoporosis; critical visceral disease. Dorsogluteal inj site due to proximity of underlying sciatic nerve. Interfered Ab-based estradiol assays. Concomitant use w/ anticoagulants. May affect ability to drive & use machines. Mild to moderate hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents.
Adverse Reactions
Hypersensitivity; hot flushes; nausea; elevated hepatic enzymes; rash; joint & musculoskeletal pain; asthenia, inj site reactions. UTI; reduced platelet count; anorexia; headache; venous thromboembolism; vomiting, diarrhoea; elevated bilirubin; back pain; vag haemorrhage; peripheral neuropathy, sciatica.
ATC Classification
L02BA03 - fulvestrant ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.
Faslodex soln for inj (pre-filled syringe) 250 mg/5 mL
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