Femara菲美華

Femara

letrozole

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Letrozole
Indications/Uses
Adjuvant treatment of postmenopausal women w/ hormone receptor positive invasive early breast cancer. Extended adjuvant treatment of hormone-dependent 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. Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable & immediate surgery not indicated.
Dosage/Direction for Use
Adult & elderly 2.5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Premenopausal endocrine status. Pregnancy & lactation.
Special Precautions
Only women of postmenopausal endocrine status should receive Femara. Formally assess bone mineral density in women w/ history of osteoporosis &/or fractures or who are at increased risk of osteoporosis, prior to adjuvant & extended adjuvant treatment intiation, & monitor during & following treatment. Rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Avoid co-administration w/ tamoxifen, other anti-oestrogens or oestrogen-containing therapies. Minor influence on the ability to drive & use machines. Patients w/ renal impairment (CrCl <10 mL/min) & severe hepatic impairment (Child-Pugh C). May induce ovulation. Not recommended in childn & adolescents.
Adverse Reactions
Hypercholesterolaemia; hot flushes; hyperhidrosis; arthralgia; fatigue (including asthenia, malaise). Decreased/increased appetite; depression; headache, dizziness; palpitations; HTN; nausea, dyspepsia, constipation, abdominal pain, diarrhoea, vomiting; alopecia, rash, dry skin, myalgia, bone pain, osteoporosis, bone fractures, arthritis; vag haemorrhage; peripheral oedema, chest pain; wt increased.
Drug Interactions
Possible diminished pharmacological action w/ tamoxifen, other anti-oestrogens or oestrogens-containing therapies. Exercise caution when concomitantly used w/ substrates of CYP450, CYP2A6 or CYP2C19, especially those w/ narrow therapeutic index eg, phenytoin, clopidogrel.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BG04 - letrozole ; Belongs to the class of enzyme inhibitors. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Femara film-coated tab 2.5 mg
Packing/Price
30's
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