Faslodex

Faslodex

fulvestrant

Manufacturer:

AstraZeneca

Distributor:

DKSH
Concise Prescribing Info
Contents
Fulvestrant
Indications/Uses
Monotherapy for 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 anti-estrogen therapy, or disease progression on anti-estrogen therapy. In combination w/ palbociclib for hormone receptor-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
Pre- & perimenopausal women should be treated w/ luteinizing hormone releasing hormone (LHRH) agonist prior to combination treatment w/ palbociclib & throughout duration of therapy. Adult (including elderly) 500 mg as 2 consecutive slow IM inj (1-2 min/inj in each buttock) at 1 mth intervals, w/ an additional 500 mg 2 wk after initial dose.
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Patients w/ bleeding diatheses, thrombocytopenia, taking anticoagulants, or critical visceral disease. Thromboembolic events in women w/ advanced breast cancer. Caution while administering at the dorsogluteal inj site. Potential risk of osteoporosis. May interfere w/ Ab based-estradiol assays. Caution in patients experiencing asthenia when driving or operating machinery. Mild to moderate hepatic impairment, severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should use effective contraception during treatment. Childn & adolescents.
Adverse Reactions
Hypersensitivity reactions; nausea; elevated hepatic enzymes (ALT, AST, ALP); rash; joint & musculoskeletal pain; asthenia, inj site reactions. UTI; reduced platelet count; anorexia; headache; hot flushes, 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.
Presentation/Packing
Form
Faslodex soln for inj 250 mg/5 mL
Packing/Price
1's
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