Eranfu

Eranfu

fulvestrant

Manufacturer:

Dr. Reddy's

Distributor:

Zuellig Pharma
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, or disease progression on 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 received prior endocrine therapy; combined w/ LH releasing hormone (LHRH) agonist in pre- or perimenopausal women.
Dosage/Direction for Use
Adult female including elderly 500 mg at 1-mth intervals w/ additional 500 mg given 2 wk after initial dose, administered 1 in each buttock as 2 consecutive 5 mL slow IM inj.
Contraindications
Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Bleeding diatheses, thrombocytopenia; critical visceral disease; thromboembolic events in women w/ advanced breast cancer; potential risk of osteoporosis. Dorsogluteal inj site due to proximity of underlying sciatic nerve. Interfered w/ Ab based-estradiol assays. Concomitant use w/ anticoagulants. 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. Pregnancy & lactation. Not recommended in childn or adolescents.
Adverse Reactions
Nausea; elevated ALT, AST & alkaline phosphatase; diarrhoea, vomiting. Monotherapy: Hypersensitivity reactions; rash; joint & musculoskeletal pain; asthenia, inj site reactions. UTI; reduced platelet count; anorexia; headache; hot flushes, VTE; elevated bilirubin; back pain; vag haemorrhage; peripheral neuropathy, sciatica. In combination w/ palbociclib: Infections; neutropenia, leukopenia, anaemia, thrombocytopenia; decreased appetite; stomatitis; alopecia, rash; fatigue, pyrexia. Dysgeusia; increased lacrimation, blurred vision, dry eyes; epistaxis; dry skin; asthenia.
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
Eranfu soln for inj 250 mg/5 mL
Packing/Price
2 × 1's
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