• Adjuvant treatment of postmenopausal women with hormone
receptor positive early breast cancer.
• Adjuvant treatment of postmenopausal women with early
breast cancer (positive or unknown oestrogen or progesterone receptor status)
who have received 5 years of adjuvant tamoxifen therapy (extended adjuvant
therapy).
• First-line treatment in postmenopausal women with
hormone-dependent advanced breast cancer.
• Treatment of advanced breast cancer in women with natural
or artificially induced postmenopausal status, who have previously been treated
with antioestrogens.
• Pre-operative therapy in postmenopausal women with
localized hormone receptor positive breast cancer, to allow subsequent
breast-conserving surgery in women not originally considered candidates for
this type of surgery. Subsequent treatment after surgery should be in
accordance with standard of care.
Adult and elderly patients
The recommended dose of Letrozole is 2.5 mg once daily. In
the adjuvant and extended adjuvant setting, treatment with Letrozole should
continue for 5 years or until tumor relapse occurs, whichever comes first. In
patients with metastatic disease, treatment with Letrozole should continue
until tumor progression is evident. No dose adjustment is required for elderly
patients.
Children: Not applicable.
Patients with hepatic and/or renal impairment
No dosage adjustment is required for patients with hepatic
impairment or renal impairment (creatinine clearance =10 mL/min.). However,
patients with severe hepatic impairment (Child-Pugh score C) should be kept
under close supervision Contraindications
Letrozole is contraindicated in known or suspected
hypersensitivity to letrozole, other aromatase inhibitors, or to any of their
ingredients. It is contraindicated during pregnancy, lactation and in
pre-menopausal women. It is also contraindicated in severe hepatic dysfunction.
Common: Plot flushes, Increased level of cholesterol
(hypercholesterolemia), Fatigue, Increased sweating, Pain in bones and joints
(arthralgia), Skin rash, Fleadache, Dizziness, Malaise (generally feeling
unwell), gastrointestinal disorders such as nausea, vomiting, indigestion,
constipation, diarrhea. Increase in or loss of appetite ,Pain in muscles
Thinning or wasting of your bones (osteoporosis), leading to bone fractures in
some cases, Swelling of arms, hands, feet, ankles (edema), Depression, Weight
increase, Flair loss, Raised blood pressure (hypertension), Abdominal pain, Dry
skin, Vaginal bleeding, Palpitations, rapid heart rate, Joint stiffness (arthritis),
Chest pain.
Rare: Nervous disorders such as anxiety, nervousness,
irritability, drowsiness, memory problems, Somnolence, insomnia, Pain or
burning sensation in the hands or wrist (carpal tunnel syndrome) Impairment of
sensation, especially that of touch ,Eye disorders such as blurred vision, eye
irritation ,Skin disorders such as itching (urticarial). Vaginal discharge or
dryness Dryness of mucous membranes, Weight decrease, Urinary tract infection,
increased frequency of urination, Cough, Increased level of enzymes, yellowing
of the skin and eyes, High blood levels of bilirubin (a breakdown product of
red blood cells)
Letrozole is contraindicated during pregnancy. Lactation
Letrozole is contraindicated during lactation.
Use in Children & Adolescents
Children and adolescents should not use this medicine.
There is no clinically significant drug interactions from coadministration of letrozole with cimetidine and warfarin & other
anticancer agents. Letrozole inhibits in vitro the cytochrome P450-isozymes
2A6, and moderately 2C19. CYP2A6 does not play a major role in drug metabolism.
Thus, clinically relevant interactions with CYP2C19 are unlikely to occur.
No specific treatment for overdose is known; treatment
should be symptomatic and supportive.
Store at temperature not exceeding 30°C in a dry place.
Protect from light and moisture.
