Luvestra

Luvestra

fulvestrant

Manufacturer:

Ebewe Pharma

Distributor:

Sandoz
Concise Prescribing Info
Contents
Fulvestrant
Indications/Uses
Monotherapy for 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 anti-estrogen therapy. In combination w/ palbociclib for hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In combination w/ LH releasing agonist (LHRH) in pre- or perimenopausal women.
Dosage/Direction for Use
Adult female including the elderly 500 mg at 1 mth interval w/ an additional 500 mg given for 2 wk after the initial dose. Administer as 2 consecutive 5 mL inj by slow IM (1-2 min/inj), 1 in each buttock.
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Patients w/ bleeding diatheses, thrombocytopenia, anticoagulant treatment; critical visceral disease. Thromboembolic events in women w/ advanced breast cancer. Administration at the dorsogluteal inj site due to proximity of underlying sciatic nerve. Risk of osteoporosis. May interfere w/ Ab based-oestradiol assays & may result to false increased level of oestradiol. May impair ability to drive or operate machinery. Mild to moderate hepatic impairment & severe renal (CrCl < 30 mL/min) impairment. Effective contraception should be used in women of child-bearing potential while on treatment. Childn ≤18 yr.
Adverse Reactions
Hypersensitivity reactions; hot flushes; nausea; elevated hepatic enzymes; rash; joint & musculoskeletal pain; asthenia, inj site reactions. UTI; reduced platelet count; anorexia; headache; VTE; 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
Luvestra soln for inj 250 mg/5 mL
Packing/Price
1's
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