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Femara菲美華

Femara

letrozole

Manufacturer:

Novartis

Distributor:

DKSH
/
Four Star
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 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 w/ hormone receptor +ve, HER-2 -ve 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
Efficacy has not been demonstrated in patients w/ hormone receptor -ve breast cancer. Should only be used in women w/ clearly established postmenopausal endocrine status. Measure LH, FSH &/or oestradiol levels before initiating treatment in patients whose menopausal status is unclear. Formally assess bone mineral density prior to commencement of adjuvant & extended adjuvant treatment in women w/ history of osteoporosis &/or fractures or who are at increased risk of osteoporosis, & monitor during & following treatment. Risk of bone effects; tendon disorders eg, tendonitis, tenosynovitis, tendon rupture. Avoid co-administration w/ tamoxifen, other anti-oestrogens or oestrogen-containing therapies. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on ability to drive & use machines. Insufficient data available in patients w/ renal impairment (CrCl <10 mL/min); severe hepatic impairment (Child-Pugh C). Increased FSH levels due to inhibition of oestrogen synthesis can induce ovulation in premenopausal women. Not recommended for use in childn & adolescents ≤17 yr.
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 (including erythematous, maculopapular, psoriasiform, & vesicular rash), dry skin; myalgia, bone pain, osteoporosis, bone fractures, arthritis; vag haemorrhage; peripheral oedema, chest pain; increased wt.
Drug Interactions
Pharmacological action may be diminished by tamoxifen, other anti-oestrogens or oestrogen-containing therapies. Decreased plasma conc w/ tamoxifen. Caution when concomitantly giving w/ medicinal products whose elimination is mainly dependent on CYP2A6 & CYP2C19, & whose therapeutic index is narrow (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 FC tab 2.5 mg
Packing/Price
30's
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