Faslodex Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Fulvestrant

Indications/Uses

Monotherapy for estrogen receptor +ve, locally advanced or metastatic breast cancer in postmenopausal women who are human epidermal growth factor receptor 2 (HER2) -ve & not previously treated w/ endocrine therapy, or -w/ disease relapse on or after adjuvant endocrine therapy, or disease progression on endocrine therapy. In combination w/ ribociclib for hormone receptor (HR) +ve, HER2 -ve advanced or metastatic breast cancer in postmenopausal women as initial therapy or following disease progression on endocrine therapy. In combination w/ abemaciclib for women w/ HR +ve, HER2 -ve advanced or metastatic breast cancer w/ disease progression following endocrine therapy. In combination w/ palbociclib for HR +ve, HER2 -ve locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

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Dosage/Direction for Use

Adult female including elderly 500 mg at 1 mth interval w/ additional 500-mg dose given 2 wk after initial dose, administered 1 in each buttock as 2 consecutive 5 mL slow IM inj.

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Overdosage

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Contraindications

Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.

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Special Precautions

Bleeding diatheses, thrombocytopenia; thromboembolic events; potential risk of osteoporosis; critical visceral disease. Dorsogluteal inj site due to proximity of underlying sciatic nerve. Interfered Ab-based estradiol assays. Long-term use. 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 during treatment & for 2 yr after last dose. Pregnancy & lactation. Not recommended in childn & adolescents.

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Use In Pregnancy & Lactation

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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.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BA03 - fulvestrant ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.

Regulatory Classification

Presentation/Packing

Form

Faslodex soln for inj (pre-filled syringe) 250 mg/5 mL

Packing/Price

2 × 1's

Faslodex

fulvestrant

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma