Fulvafit 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

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 antioestrogen therapy, or disease progression on antioestrogen 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 have received prior endocrine therapy; & w/ luteinising hormone releasing hormone (LHRH) agonist in pre- or perimenopausal women.

Click to view Fulvafit detailed prescribing information

Dosage/Direction for Use

IM Administer as 2 consecutive 5 mL by slow inj (1-2 min/inj), 1 in each buttock (gluteal area). Adult female (including elderly) 500 mg at intervals of 1 mth, 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.

Click to view Fulvafit detailed prescribing information

Overdosage

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

Contraindications

Hypersensitivity. Severe hepatic impairment. Pregnancy & lactation.

Click to view Fulvafit detailed prescribing information

Special Precautions

Patients w/ bleeding diatheses, thrombocytopenia or those on anticoagulant treatment. Inj site-related events (eg, sciatica, neuralgia, neuropathic pain & peripheral neuropathy). Administration at dorsogluteal inj site. Thromboembolic events in women w/ advanced breast cancer. Potential risk of osteoporosis. May interfere w/ Ab-based estradiol assays & result in falsely increased estradiol levels. Contains ethanol 10% w/v & benzyl alcohol. May affect ability to drive & use machines 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 last dose. Not recommended in childn & adolescents.

Click to view Fulvafit detailed prescribing information

Use In Pregnancy & Lactation

Click to view Fulvafit detailed prescribing information

Adverse Reactions

Hypersensitivity reactions; hot flushes; nausea; elevated hepatic enzymes (ALT, AST, alkaline phosphatase); rash; joint & musculoskeletal pain; asthenia, inj site reactions. UTI; reduced platelet count; anorexia; headache; VTE; vomiting, diarrhea; 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.

Click to view Fulvafit detailed prescribing information

Caution For Usage

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

Storage

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

Description

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

Action

View Fulvafit 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

Fulvafit soln for inj 250 mg/5 mL

Packing/Price

2 × 1's

Fulvafit

fulvestrant

Manufacturer:

Eugia Aurobindo

Distributor:

Tersia Pharma

Marketer:

Tersia Pharma