Indications: Chronic myeloid leukemia (CML): Treatment of newly-diagnosed Philadelphia chromosome- positive CML (Ph+ CML) in chronic phase treatment of chronic and accelerated phase Ph+ CML refractory or intolerant to prior therapy.

Cautions: history of pancreatitis susceptibility to QT- interval prolongation (including electrolyte disturbances concomitant use of drugs that prolong QT interval).

Contra-indications: Use in patients with hypokalemia, hypomagnesemia, or long QT syndrome.

Canadian labeling: Additional contraindication (not in U.S. labeling): Hypersensitivity to nilotinib or any component of the formulation (persistent QTc >480 msec).

Hepatic impairment: manufacturer advises caution

Renal impairment: nilotinib and its metabolites have minimal renal excretion (dosage adjustments for renal dysfunction may not be necessary).

Pregnancy: manufacturer advises avoid unless potential benefit outweighs risk (toxicity in animal studies) effective contraception required during treatment.

Side Effects: Most common: abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, anorexia, weight changes; palpitation, QT-interval prolongation, hypertension, oedema, flushing; dyspnea, cough, dysphonia; headache, fatigue, asthenia, dizziness, paraesthesia, insomnia, vertigo; hypomagnesaemia, hyperkalaemia, blood glucose changes; bone pain, arthralgia, muscle spasm; urticaria, erythema, hyperhidrosis, dry skin, rash, pruritus. less commonly: hepatitis, pancreatitis, dry mouth, chest pain, cardiac failure, arrhythmias, pericardial effusion, coronary artery disease, cardiomegaly, cardiac murmur, bradycardia, hypertensive crisis, haemorrhage, melaena, haematoma, pleural effusion, interstitial lung disease, migraine, hypoaesthesia, hyperaesthesia, depression, anxiety, tremor, influenza-like symptoms, hyperthyroidism, breast pain, gynaecomastia, erectile dysfunction, dysuria, urinary frequency, hypokalaemia, hyponatraemia, hypocalcaemia, hypophosphataemia, dehydration, decreased visual acuity, conjunctivitis, dry eyes, epistaxis, and ecchymosis.

Dose: Newly diagnosed chronic myeloid leukaemia, chronic phase: ADULT over 18 years: 300 mg twice daily Chronic and accelerated phase chronic myeloid leukaemia: ADULT over 18 years: 400 mg twice daily.