Contraindications: Hypersensitivity to letrozole or excipients. Premenopausal endocrine status; pregnancy, breast-feeding.
Precautions/Warnings: Careful consideration of risk/benefit in patients with creatinine clearance <10 mL/ min. Patients with severe hepatic impairment (Child-Pugh score C) should be kept under close supervision. Consider adequate contraception in women who have the potential to become pregnant, including women who are perimenopausal or who recently became postmenopausal, until postmenopausal status is fully established. Monitoring of bone health.
Adverse reactions:
Most frequent adverse reactions: hot flushes, nausea, fatigue, arthralgia.
Common adverse reactions: anorexia, appetite increase, peripheral oedema, headache, dizziness, malaise, vomiting, dyspepsia, constipation, diarrhoea, alopecia, increased sweating, rash, myalgia, bone pain, osteoporosis, bone fractures, weight increase, hypercholesterolemia, depression.
Uncommon, rare or very rare and potentially serious adverse reactions include: leukopenia, cataract, cerebrovascular accident or infarction, thrombophlebitis, pulmonary embolism, arterial thrombosis, general edema, ischemic cardiovascular disease, angioedema, anaphylactic reaction, hepatitis, toxic epidermal necrolysis and erythema multiforme.
Note: Before prescribing, please read full prescribing information.
