Letero

Letero

letrozole

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Letrozole
Indications/Uses
Adjuvant treatment of postmenopausal women w/ hormone receptor positive invasive early breast cancer. Extended adjuvant treatment of invasive early breast cancer in postmenopausal women who have received 5 yr of standard adjuvant tamoxifen therapy. 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/ antiestrogens.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Premenopausal endocrine status. Pregnancy & lactation.
Special Precautions
Not indicated in hormone receptor negative diseases. Monitor overall bone health during treatment. Measure LH, FSH &/or estradiol levels before initiating treatment in patients w/ unclear menopausal status. Co-administration w/ tamoxifen, other antiestrogens or estrogen-containing therapies. May affect ability to drive & use machines. Renal (CrCl <10 mL/min) & severe hepatic impairment (Child-Pugh score C). Premenopausal women. Not recommended in childn & adolescents up to 17 yr.
Adverse Reactions
Hypercholesterolemia; hot flushes; increased sweating; arthralgia; fatigue (including asthenia, malaise). Anorexia, increased appetite; depression; headache, dizziness; HTN; nausea, vomiting, dyspepsia, constipation, diarrhoea, abdominal pain; alopecia, dry skin, rash; myalgia, bone pain & fractures, osteoporosis; vag bleeding; peripheral oedema; increased wt.
Drug Interactions
Increased plasma conc by strong CYP3A4 (eg, ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin & telithromycin) & CYP2A6 (eg, methoxsalen) inhibitors. Decreased plasma conc by tamoxifen & CYP3A4 inducers (eg, phenytoin, rifampicin, carbamazepine, phenobarb & St. John's wort). Altered systemic serum conc of drugs mainly dependent on CYP2C19 elimination & 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
Letero FC tab 2.5 mg
Packing/Price
30's
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