Faslodex

Faslodex

fulvestrant

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Fulvestrant
Indications/Uses
Estrogen receptor +ve, locally advanced or metastatic breast cancer in postmenopausal women not previously treated w/ endocrine therapy or w/ disease relapse on or after adjuvant antiestrogen therapy or disease progression on antiestrogen therapy. In combination w/ palbociclib or abemaciclib for hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve locally advanced or metastatic breast cancer in women w/ disease progression following endocrine therapy. In combination w/ ribociclib for HR +ve, HER2 -ve locally advanced or metastatic breast cancer in postmenopausal women as initial endocrine based therapy or following disease progression on endocrine therapy.
Dosage/Direction for Use
Adult female (including elderly) 500 mg at 1-mth intervals w/ an additional 500 mg given 2 wk after initial dose. Administer as 2 consecutive 5 mL inj by slow IM (1-2 min/inj), 1 in each buttock (gluteal area).
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Carefully administer at the dorsogluteal inj site due to proximity of the underlying sciatic nerve; possible inj site related events including sciatica, neuralgia, neuropathic pain & peripheral neuropathy. Patients w/ bleeding diatheses, thrombocytopenia or those taking anticoagulants. Possible thromboembolic events in women w/ advanced breast cancer. Potential risk of osteoporosis. May interfere w/ oestradiol measurement by immunoassay resulting in falsely elevated oestradiol levels. Possible asthenia; observe caution when driving or operating machinery. Mild to moderate hepatic & severe renal (CrCl <30 mL/min) impairment. Women of childbearing potential should use effective contraception during treatment & for 2 yr after the last dose. Not recommended for use in childn or adolescents.
Adverse Reactions
Nausea; rash; joint & musculoskeletal pain; hot flushes; asthenia, inj site reactions; hypersensitivity reactions; elevated hepatic enzymes (ALT, AST, ALP). Headache; vomiting, diarrhoea; UTI; back pain; anorexia; VTE; peripheral neuropathy, sciatica; elevated bilirubin; vag haemorrhage; reduced platelet count.
Drug Interactions
May interfere w/ Ab-based oestradiol assays; may result in falsely increased oestradiol levels.
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
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