Fulvestrant Sandoz

Fulvestrant Sandoz

fulvestrant

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Fulvestrant
Indications/Uses
Monotherapy for postmenopausal women w/ oestrogen receptor +ve, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant antiestrogen therapy, or disease progression on therapy w/ antiestrogen. In combination w/ palbociclib for hormone receptor (HR) +ve , human epidermal growth factor receptor 2 (HER2) -ve locally advanced or metastatic breast cancer in woman w/ prior endocrine therapy. In combination w/ palbociclib & LH releasing hormone (LHRH) agonist in pre- or perimenopausal women.
Dosage/Direction for Use
Administer as 2 consecutive 5 mL inj by slow IM inj (1-2 min/inj), 1 in each buttock. Adult females (including the elderly) 500 mg at 1 mth interval w/ additional 500 mg dose given 2 wk after the initial dose.
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Bleeding diastheses, thrombocytopenia, anticoagulant intake. Thromboembolic events in women w/ advanced breast cancer. Caution in administering at dorsogluteal inj site. Risk of osteoporosis. Critical visceral disease. May interfere w/ Ab based-oestradiol assays & may result in falsely increased oestradiol levels. Mild to moderate hepatic impairment. Severe renal impairment (CrCl <30 mL/min). May influence ability to drive or use machines. Patients of childbearing potential should use effective contraception during treatment & for 2 yr after the last dose. Contraindicated in pregnancy & lactation. Childn & adolescents.
Adverse Reactions
Hypersensitivity reactions; hot flushes; nausea; elevated hepatic enzymes (ALT, AST, alkaline phosphatase); 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.
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
Fulvestrant Sandoz soln for inj 250 mg/5 mL
Packing/Price
1's
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