Fulvestrant Eurodrug: Dosing, Side Effect & Interaction

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

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 w/ prior endocrine therapy; & w/ LH-releasing hormone (LHRH) agonist in pre- or perimenopausal women.

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Dosage/Direction for Use

IM Administer as 2 consecutive 5 mL slow inj (1-2 min/inj), 1 in each buttock (gluteal area). Adult female (including elderly) 500 mg at 1 mth interval w/ additional 500 mg dose given 2 wk after initial dose. Pre/perimenopausal women Treat w/ LHRH agonists prior to combination treatment of fulvestrant + palbociclib & throughout duration of treatment.

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Overdosage

View Fulvestrant Eurodrug overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.

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Special Precautions

May cause allergic reactions due to benzyl alcohol content. Thromboembolic events in women w/ advanced breast cancer. Inj site related events including sciatica, neuralgia, neuropathic pain & peripheral neuropathy; caution while administering at dorsogluteal inj site due to proximity of sciatic nerve. Potential risk of osteoporosis. Patients w/ bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment; critical visceral disease; liver disease & epilepsy. Alcoholic patients. May interfere w/ Ab based-estradiol assays & result in falsely increased estradiol levels. Mild to moderate hepatic impairment. Severe renal impairment (CrCl <30 mL/min). May influence ability to drive or use machines. Patients of childbearing potential should use effective contraception during treatment & for 2 yr after last dose. Not recommended in childn & adolescents.

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Use In Pregnancy & Lactation

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Adverse Reactions

Nausea, vomiting, diarrhoea; rash; increased AST, ALT. Asthenia. Monotherapy: Hypersensitivity reactions; hot flushes; elevated hepatic enzymes (alkaline phosphatase); joint & musculoskeletal pain; inj site reactions. UTI; reduced platelet count; anorexia; headache; VTE; elevated bilirubin; back pain; vag haemorrhage; peripheral neuropathy, sciatica. In combination w/ palbociclib: Infections; neutropenia, leukopenia, anaemia, thrombocytopenia; decreased appetite; stomatitis; alopecia; fatigue, pyrexia. Dysgeusia; increased lacrimation, blurred vision, dry eye; epistaxis; dry skin.

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Caution For Usage

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

Storage

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

Description

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

Action

View Fulvestrant Eurodrug mechanism of action for pharmacodynamics and pharmacokinetics details.

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

Fulvestrant Eurodrug soln for inj 250 mg/5 mL

Packing/Price

2 × 1's

Fulvestrant Eurodrug

fulvestrant

Manufacturer:

Jiangsu Hansoh

Distributor:

Pacific Healthcare