Faslodex

Faslodex

fulvestrant

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Fulvestrant
Indications/Uses
Monotherapy for treatment of estrogen receptor positive, 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 for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
Dosage/Direction for Use
Adult & elderly 500 mg (2 consecutive inj) slow IM (1-2 min/inj, administered 1 in each buttock) at 1 mth intervals, w/ an additional 500 mg 2 wk after the initial dose.
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Patients w/ bleeding diatheses, thrombocytopenia or on anticoagulant treatment; w/ critical visceral disease. Thromboembolic events in women w/ advanced breast cancer. Inj site related events (eg, sciatica, neuralgia, neuropathic pain, & peripheral neuropathy). Use w/ caution while administering at the dorsogluteal inj site. Potential risk of osteoporosis. Interference w/ estradiol antibody assays. 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 while on treatment. 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; venous thromboembolism; vomiting, diarrhoea; elevated bilirubin; back pain; vag haemorrhage; neuropathy peripheral, 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 inj 250 mg/5 mL
Packing/Price
2's
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