Luvestra 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 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 who have received prior endocrine therapy. Combination treatment w/ palbociclib in pre- or perimenopausal women should be combined w/ LH releasing hormone (LHRH) agonist.

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Dosage/Direction for Use

Adult female including the elderly 500 mg at 1 mth interval w/ an additional 500 mg given for 2 wk after the initial dose. Administer as 2 consecutive 5 mL inj by slow IM (1-2 min/inj), 1 in each buttock.

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Overdosage

View Luvestra 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

Patients w/ bleeding diatheses, thrombocytopenia, anticoagulant treatment; critical visceral disease. Thromboembolic events in women w/ advanced breast cancer. Administration at the dorsogluteal inj site due to proximity of underlying sciatic nerve. Risk of osteoporosis. May interfere w/ Ab based-oestradiol assays & may result to false increased level of oestradiol. May impair ability to drive or operate machinery. Patients w/ mild to moderate hepatic impairment & severe renal (CrCl < 30 mL/min) impairment. Women of childbearing potential should use effective contraception during treatment & for 2 yr after the last dose. Not recommended in childn ≤18 yr.

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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

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

Storage

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

Description

View Luvestra 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.

Regulatory Classification

Presentation/Packing

Form

Luvestra soln for inj 250 mg/5 mL

Packing/Price

1's

Luvestra

fulvestrant

Manufacturer:

Ebewe Pharma

Distributor:

Sandoz