Faslodex

Faslodex

fulvestrant

Manufacturer:

AstraZeneca

Marketer:

AstraZeneca
Concise Prescribing Info
Contents
Fulvestrant
Indications/Uses
Postmenopausal women w/ estrogen receptor +ve, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-estrogen therapy or disease progression on therapy w/ anti-estrogen; estrogen receptor +ve, human epidermal growth receptor 2 (HER2) -ve locally advanced or metastatic breast cancer not previously treated w/ endocrine therapy.
Dosage/Direction for Use
IM Adult female (including the elderly) 500 mg at 1-mth intervals, w/ an additional 500 mg given 2 wk after initial dose. Administer as 2 consecutive 5 mL by slow inj (1-2 min/inj), 1 in each buttock (gluteal area).
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Patients w/ bleeding diatheses, thrombocytopenia or taking anticoagulant treatment. Thromboembolic events in women w/ advanced breast cancer. Inj site related events (eg, sciatica, neuralgia, neuropathic pain, & peripheral neuropathy). Administration at dorsogluteal inj site. Potential risk of osteoporosis. May interfere w/ Ab based-estradiol assays & may result in falsely increased levels of estradiol. May impair ability to drive or operate machinery due to asthenia. Mild to moderate hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should use effective contraception during treatment & for 2 yr after the last dose. Discontinue breastfeeding during treatment. Not recommended for use in childn & adolescents.
Adverse Reactions
Hypersensitivity reactions; hot flushes; nausea; elevated hepatic enzymes (ALT, AST, ALP); rash; joint & musculoskeletal pain; asthenia, inj site reactions. UTI; reduced platelet count; anorexia; headache; VTE; vomiting, diarrhoea; elevated bilirubin; back pain; vag haemorrhage; peripheral neuropathy, sciatica.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BA03 - fulvestrant ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Faslodex soln for inj 250 mg/5 mL
Packing/Price
(pre-filled syringe) 2 × 1's (Rp15,165,051/boks)
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