Femara

Femara

letrozole

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Letrozole
Indications/Uses
Adjuvant treatment of postmenopausal women w/ hormone-receptor +ve early breast cancer; early breast cancer (+ve or unknown oestrogen or progesterone-receptor status) who have received 5 yr adjuvant tamoxifen therapy (extended adjuvant therapy). 1st-line treatment in postmenopausal women w/ hormone-dependent advanced breast cancer. Advanced breast cancer in women w/ natural- or artificially-induced postmenopausal status who have previously been treated w/ antioestrogens. Pre-op therapy in postmenopausal women w/ localised hormone-receptor +ve breast cancer.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Premenopausal endocrine status. Pregnancy & lactation.
Special Precautions
Osteoporosis &/or bone fractures. Measure LH, FSH &/or estradiol levels prior to treatment. Avoid co-administration w/ tamoxifen, other anti-estrogens or estrogen-containing therapies. May affect ability to drive & use machines. Renal & severe hepatic impairment. Women of childbearing potential should use effective contraception. Not recommended in childn & adolescents ≤17 yr.
Adverse Reactions
Hypercholesterolemia; hot flush; hyperhidrosis; arthralgia; fatigue, asthenia, malaise. Decreased/increased appetite; depression; headache, dizziness, vertigo; palpitations; HTN; nausea, vomiting, dyspepsia, constipation, diarrhoea, abdominal pain; alopecia, dry skin, rash, 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. Medicinal products w/ CYP2C19-dependent elimination & 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
3 × 10's
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