Ovalia 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 Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Letrozole

Indications/Uses

Adjuvant treatment of postmenopausal women w/ hormone receptor +ve invasive early breast cancer. Extended adjuvant treatment of hormone-dependent early invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 yr. 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 have previously been treated w/ anti-oestrogens. Neoadjuvant treatment of postmenopausal women w/ hormone receptor +ve, HER-2 -ve breast cancer where chemotherapy is not suitable & immediate surgery not indicated.

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Dosage/Direction for Use

Adult & elderly 2.5 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Premenopausal endocrine status. Premenopausal, pregnant or lactating women.

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Special Precautions

Efficacy has not been demonstrated in hormone receptor -ve breast cancer. Tendonitis & tendon rupture may rarely occur. Measure LH, FSH &/or oestradiol levels prior to treatment in patients whose postmenopausal status is unclear. Assess bone mineral density prior to commencement of adjuvant & extended adjuvant treatment & monitor during & following treatment in women w/ history of osteoporosis &/or fractures, or who are at risk of osteoporosis. Avoid co-administration w/ tamoxifen, other anti-oestrogens or oestrogen-containing therapies. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Insufficient data on patients w/ renal impairment (CrCl <10 mL/min); severe hepatic impairment (Child-Pugh grade C). Not recommended in childn & adolescents up to 17 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hot flushes, hypercholesterolaemia, arthralgia, fatigue, increased sweating & nausea. Osteoporosis &/or bone fractures & CV events.

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Drug Interactions

Pharmacological action may be diminished & plasma conc be decreased w/ tamoxifen, other anti-oestrogens or oestrogen-containing therapies. Concomitant use w/ drugs whose disposition is mainly dependent on CYP2A6 & CYP2C19 & w/ narrow therapeutic index eg, phenytoin, clopidogrel.

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Storage

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Description

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

Action

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MIMS Class

Cancer Hormone Therapy

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Ovalia FC tab 2.5 mg

Packing/Price

30's

Ovalia

letrozole

Manufacturer:

Globela Pharma

Distributor:

Corbridge