Fulvestrant Sandoz

Fulvestrant Sandoz

fulvestrant

Manufacturer:

Ebewe Pharma

Distributor:

Zuellig Pharma

Marketer:

Sandoz
Concise Prescribing Info
Contents
Fulvestrant
Indications/Uses
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 or abemaciclib for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women w/ disease progression following endocrine therapy. In combination w/ ribociclib for HR-positive, HER2-negative 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
IM Adult including elderly 500 mg at intervals of 1 mth, w/ an additional 500-mg dose given 2 wk after the initial dose. Administer as 2 consecutive 5 mL slow inj (1-2 min/inj), 1 in each gluteal area.
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Patients w/ bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment. Inj site related events including sciatica, neuralgia, neuropathic pain & peripheral neuropathy. Administration at the dorsogluteal inj site. Consider possible thromboembolic events in women w/ advanced breast cancer when prescribing. Potential risk of osteoporosis. Falsely elevated oestradiol level w/ measurement by immunoassay. May affect the ability to drive & use machines. Mild to moderate hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Patients of childbearing potential should be advised to use effective contraception during treatment & for 2 yr after the last dose. Not recommended in childn & adolescent.
Adverse Reactions
Nausea; rash; joint & musculoskeletal pain; hot flushes; asthenia, inj site reactions; hypersensitivity reactions; elevated ALT, AST & alkaline phosphatase levels. Headache; vomiting, diarrhoea; UTI; back pain; anorexia; venous thromboembolism; peripheral neuropathy, sciatica; elevated bilirubin; vag haemorrhage; reduced platelet count.
Drug Interactions
May interfere w/ Ab-based oestradiol assays.
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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