Letrozole Sandoz

Letrozole

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.

Adult & elderly 2.5 mg once daily. Continue until tumour progression is evident in patients w/ advanced or metastatic breast cancer. Continue for 5 yr or until tumour relapse, whichever is 1st, in the adjuvant & extended adjuvant setting. Continue for 4-8 mth in the neo-adjuvant setting.

May be taken with or without food.

Hypersensitivity. Premenopausal endocrine status. Pregnancy & lactation.

Only women of postmenopausal endocrine status should receive Letrozole Sandoz. Potent oestrogen-lowering agent. 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 w/ letrozole. Avoid co-administration w/ tamoxifen, other anti-oestrogens or oestrogen-containing therapies. Not recommended for patients w/ rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Patients w/ CrCl <10 mL/min; severe hepatic impairment (Child-Pugh C). Not recommended for use in childn & adolescents.

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

Diminished pharmacological action w/ tamoxifen, other anti-oestrogens or oestrogen-containing therapies. Decreased plasma conc w/ tamoxifen. Caution when concomitantly used w/ medicinal products whose elimination is mainly dependent on CYP2A6 & CYP2C19 & whose therapeutic index is narrow (eg, phenytoin, clopidrogel).

Cancer Hormone Therapy

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

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