Fulevex 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 Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Fulvestrant

Indications/Uses

Monotherapy for treatment of 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. In combination w/ palbociclib for treatment of 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. Combination treatment w/ palbociclib + luteinizing hormone releasing hormone (LHRH) agonist in pre- or perimenopausal women.

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Dosage/Direction for Use

IM Administer as 2 consecutive 5 mL inj by slow IM (1-2 min/inj), 1 in each buttock (gluteal area). Adult female (including elderly) 500 mg at 1 mth intervals w/ additional 500 mg given 2 wk after initial dose. Pre-/perimenopausal women Administer w/ LHRH agonists prior starting treatment w/ palbociclib.

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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 those taking anticoagulant treatment. Inj site related events including sciatica, neuralgia, neuropathic pain & peripheral neuropathy. Thromboembolic events. Potential risk of osteoporosis. Administration at dorsogluteal inj site due to proximity of underlying sciatic nerve. May affect ability to drive & use machines due to asthenia. Mild to moderate hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Advise women of childbearing potential to use effective contraception during treatment. Not recommended for use in childn or adolescents.

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Use In Pregnancy & Lactation

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Adverse Reactions

GI effects (eg, nausea, vomiting, constipation, diarrhea, abdominal pain), headache, back pain, vasodilation (hot flushes), & pharyngitis.

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Drug Interactions

May interfere w/ Ab-based oestradiol assay resulting in falsely increased oestradiol levels.

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Caution For Usage

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

Storage

View Fulevex storage conditions for details to ensure optimal shelf-life.

Description

View Fulevex description for details of the chemical structure and excipients (inactive components).

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.

Thai FDA Category

Presentation/Packing

Form

Fulevex soln for inj 250 mg/5 mL

Packing/Price

1's

Fulevex

fulvestrant

Manufacturer:

Intas Pharmaceuticals

Distributor:

DKSH

Marketer:

DKSH