Nilotinib

Should be taken on an empty stomach. Avoid food at least 2 hr before & at least 1 hr after a dose. Swallow whole, do not chew/crush. Avoid grapefruit products.

Patients with hypokalaemia, hypomagnesaemia or long QT syndrome. Concomitant use with potent CYP3A4 inhibitors or inducers, antiarrhythmics and other QT prolonging drugs.

Patients with pre-existing risk factors of CV disease, electrolyte imbalance, history of pancreatitis and total gastrectomy. Maintain adequate hydration and correct uric acid levels, hypomagnesaemia, hypokalaemia and other electrolyte imbalances prior to therapy. Hepatic impairment. Pregnancy and lactation. Monitoring Parameters Monitor Philadelphia chromosome status, ECG, QTc, CBC, electrolytes (e.g. K, Ca, Mg), lipid profile, blood glucose, hepatic function (ALT/AST, bilirubin, alkaline phosphatase), serum lipase and amylase, uric acid, and bone marrow assessments at baseline, periodically thereafter or as clinically indicated. Monitor growth and development of paediatric patients.

Significant: Bone marrow suppression (e.g. myelosuppression, thrombocytopenia, neutropenia, anaemia), cardiovascular and arterial vascular-occlusive events, electrolyte imbalance (e.g. hypophosphataemia, hyper/hypokalaemia, hypocalcaemia, hyponatremia), hepatotoxicity, fluid retention (e.g. pleural and pericardial effusions, ascites, pulmonary oedema), tumor lysis syndrome. Ear and labyrinth disorders: Vertigo. Eye disorders: Eye pruritus, conjunctivitis, dry eye, xerophthalmia. I>Gastrointestinal disorders: Nausea, constipation, diarrhoea, vomiting, abdominal pain, dyspepsia. General disorders and administration site conditions: Fatigue, pyrexia, asthenia, peripheral oedema. Hepatobiliary disorders: Abnormal hepatic function. Infections and infestations: Folliculitis, upper respiratory tract infection. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, muscle spasms, bone pain, pain in extremity, back pain. Nervous system disorders: Headache, dizziness. Psychiatric disorders: Insomnia. Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea. Skin and subcutaneous tissue disorders: Rash, pruritis, alopecia, dry skin, erythema. Vascular disorders: Hypertension.
Potentially Fatal: Haemorrhage, QT prolongation, sudden death.

May decrease nilotinib efficacy with PPIs.

Targeted Cancer Therapy

L01EA03 - nilotinib