Letrozole

May be taken with or without food.

Premenopausal endocrine status. Pregnancy and lactation.

Patient with history of osteoporosis and/or fracture or who are at increased risk of osteoporosis; preexisting CV disease (including ischaemic heart disease) or risk factors associated with CV disease. Severe hepatic impairment (Child-Pugh class C). Patient Counselling This drug may cause somnolence, dizziness or fatigue, if affected, do not drive or operate machinery. Monitoring Parameters Evaluate pregnancy status and confirm postmenopausal status before treatment initiation. Monitor CV and hepatic function; cholesterol panel and BMD. Assess for signs of hypertension, dyspnoea, and gastrointestinal upset.

Significant: Increased total serum cholesterol, decreased BMD, osteoporosis, bone fracture; angina pectoris, acute MI; new-onset or exacerbation of existing arthralgia, joint stiffness, and/or ostealgia; tenosynovitis (trigger finger), carpal tunnel syndrome. Rarely, tendonitis and tendon ruptures. Cardiac disorders: Palpitations, chest pain. Gastrointestinal disorders: Nausea, vomiting, constipation, diarrhoea, dyspepsia, abdominal pain. General disorders and administration site conditions: Fatigue, asthenia, malaise, peripheral oedema. Investigations: Weight gain. Metabolism and nutrition disorders: Anorexia, increased appetite. Musculoskeletal and connective tissue disorders: Myalgia, arthritis. Nervous system disorders: Headache, dizziness. Psychiatric disorders: Depression. Reproductive system and breast disorders: Vaginal bleeding. Skin and subcutaneous tissue disorders: Increased sweating, alopecia, dry skin, rash (including erythematous, maculopapular, psoriasiform and vesicular rash). Vascular disorders: Hot flush, hypertension.

Tamoxifen, other anti-estrogens or estrogen-containing drugs may reduce the pharmacological effect of letrozole. Concurrent use with strong CYP3A4 inhibitors (e.g. clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, ritonavir) and CYP2A6 inhibitors (e.g. methoxsalen) may increase the exposure to letrozole. Decreased plasma concentrations with CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital).

Hormonal Chemotherapy

L02BG04 - letrozole ; Belongs to the class of enzyme inhibitors. Used in endocrine therapy.