Letrocord 2.5: Side Effects & Dosing

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 Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Letrozole

Indications/Uses

1st-line treatment in postmenopausal women w/ hormone-dependent advanced breast cancer. Advanced breast cancer after relapse or disease progression in women w/ natural or artificially induced postmenopausal endocrine status who previously treated w/ anti-oestrogens. Adjuvant treatment of postmenopausal women w/ hormone receptor +ve invasive early breast cancer. Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who received prior standard adjuvant tamoxifen therapy for 5 yr. Neo-adjuvant treatment of postmenopausal women w/ hormone receptor +ve, HER-2 -ve breast cancer where chemotherapy is not suitable & immediate surgery is not indicated.

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Dosage/Direction for Use

Adult & elderly 2.5 mg once daily. Advanced or metastatic breast cancer Continue treatment until tumour progression is evident. Adjuvant & extended adjuvant setting Continue treatment for 5 yr or until tumour relapse occur, whichever is 1st. Adjuvant setting Sequential treatment schedule: Letrozole 2 yr, followed by tamoxifen 3 yr. Neo-adjuvant setting Continue treatment for 4-8 mth.

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Overdosage

View Letrocord 2.5 overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Premenopausal endocrine status. Pregnancy & lactation.

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Special Precautions

Assess bone mineral density prior commencement of adjuvant & extended adjuvant treatment & monitor during & following treatment in women w/ history of osteoporosis &/or fractures or who are at increased risk of osteoporosis. Measure LH, FSH &/or oestradiol levels before initiating treatment. Avoid co-administration w/ tamoxifen, other anti-oestrogens or oestrogen-containing therapy. Not recommended in patients w/ galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Renal impairment w/ CrCl <10 mL/min. Severe hepatic impairment (Child-Pugh C). Not recommended in childn & adolescents ≤17 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypercholesterolaemia; hot flushes; increased sweating; arthralgia; fatigue including asthenia, malaise. Anorexia, increased appetite; depression; headache, dizziness; HTN; nausea, dyspepsia, constipation, abdominal pain, diarrhoea, vomiting; alopecia, rash including erythematous, maculopapular, psoriasiform, & vesicular rash, dry skin; myalgia, bone pain & fractures, osteoporosis; vag bleeding; peripheral oedema; increased wt.

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Drug Interactions

May diminish action w/ tamoxifen, other anti-oestrogens or oestrogen-containing therapies. Decreased plasma conc w/ tamoxifen. Concomitant use w/ medicinal products whose elimination is mainly dependent on CYP 450, 2A6 & 2C19 isoenzymes; narrow therapeutic index eg, phenytoin, clopidogrel.

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Storage

View Letrocord 2.5 storage conditions for details to ensure optimal shelf-life.

Description

View Letrocord 2.5 description for details of the chemical structure and excipients (inactive components).

Action

View Letrocord 2.5 mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BG04 - letrozole ; Belongs to the class of enzyme inhibitors. Used in treatment of neoplastic diseases.

Thai FDA Category

Presentation/Packing

Form

Letrocord 2.5 FC tab 2.5 mg

Packing/Price

3 × 10's

Letrocord 2.5

letrozole

Manufacturer:

Accord Healthcare

Distributor:

Indochina Healthcare

Marketer:

Accord Healthcare