Femara

Femara

letrozole

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Letrozole
Indications/Uses
Adjuvant treatment of postmenopausal women w/ hormone receptor +ve invasive early breast cancer. Extended adjuvant treatment of invasive early 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-estrogens. 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
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Premenopausal endocrine status. Pregnancy & lactation.
Special Precautions
Not indicated in hormone receptor -ve disease. Monitor overall bone health during treatment. Measure LH, FSH &/or estradiol levels prior to treatment in patients whose postmenopausal status is unclear. Avoid co-administration w/ tamoxifen, other anti-estrogens or estrogen-containing therapies. Renal impairment (CrCl <10 mL/min). Severe hepatic impairment (Child-Pugh score C). Caution when driving or using machines. Sexually-active females of reproductive potential should use effective contraception during & for 20 days after treatment. May impair fertility in males of reproductive potential. Not recommended in childn & adolescents up to 17 yr.
Adverse Reactions
Hypercholesterolemia; hot flush; hyperhidrosis; arthralgia; fatigue (including asthenia, malaise). Decreased or increased appetite; depression; headache, dizziness, vertigo; palpitations; HTN; nausea, vomiting, dyspepsia, constipation, diarrhea, abdominal pain; alopecia, dry skin, rash (including erythematous, maculopapular, psoriaform & vesicular rash); myalgia, bone pain & fractures, osteoporosis, arthritis, back pain; vag haemorrhage; peripheral oedema, chest pain; increased wt; fall.
Drug Interactions
Increased plasma conc w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, telithromycin; CYP2A6 inhibitors eg, methoxsalen. Decreased plasma conc w/ CYP3A4 inducers eg, phenytoin, rifampicin, carbamazepine, phenobarb, St. John's wort. Reduced plasma levels w/ tamoxifen. Concomitant use w/ medicinal products whose elimination is mainly dependent on CYP2C19 & w/ narrow therapeutic index eg, 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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