Faslodex Dosage & Drug Information

Concise Prescribing Info Bahasa 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

Postmenopausal women w/ estrogen receptor +ve, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-estrogen therapy or disease progression on therapy w/ anti-estrogen; estrogen receptor +ve, human epidermal growth receptor 2 (HER2) -ve locally advanced or metastatic breast cancer not previously treated w/ endocrine therapy. In combination w/ abemaciclib for hormone receptor (HR) +ve, HER2 -ve locally advanced or metastatic breast cancer in women w/ disease progression after endocrine therapy. In combination w/ ribociclib for HR +ve, HER2 -ve advanced or metastatic breast cancer in postmenopausal women as initial endocrine based therapy or after disease progression following endocrine therapy.

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Dosage/Direction for Use

IM Administer as 2 consecutive 5 mL by slow inj (1-2 min/inj), 1 in each buttock (gluteal area). Monotherapy Adult female (including elderly) 500 mg at 1-mth intervals w/ additional 500 mg given 2 wk after initial dose. In combination w/ abemaciclib Faslodex 500 mg on days 1, 15, 29 & once mthly thereafter + abemaciclib 150 mg orally twice daily. In combination w/ ribociclib Faslodex 500 mg on days 1, 15, 29 & once mthly thereafter + ribociclib 600 mg orally once daily for 21 days followed by 7 days off-treatment to complete 28 days cycle.

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Overdosage

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Contraindications

Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.

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Special Precautions

Patients w/ bleeding diatheses, thrombocytopenia or taking anticoagulant treatment. Thromboembolic events in women w/ advanced breast cancer. Possible inj site-related events (eg, sciatica, neuralgia, neuropathic pain & peripheral neuropathy). Administration at dorsogluteal inj site. Potential risk of osteoporosis. Contains ethanol 10% w/v & benzyl alcohol. May interfere w/ Ab based-estradiol assays & may result in falsely increased estradiol levels. May impair ability to drive or operate machinery due to asthenia. 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 the last dose. Discontinue breastfeeding during treatment. Not recommended for use 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 (ALT, AST, ALP); 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

For caution against possible variation of physical aspect of medicine... Click to view Faslodex detailed prescribing information

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 250 mg/5 mL

Packing/Price

(pre-filled syringe) 2 × 1's (Rp15,165,051/boks)

Faslodex

fulvestrant

Manufacturer:

AstraZeneca

Marketer:

AstraZeneca