Uses of NILOREN CAPSULE: - Blood cancer (Chronic myeloid leukaemia) Chronic myelogenous leukaemia Patients with hypokalaemia, hypomagnaesemia or long QT syndrome. Pregnancy.

How to use Nilotinib: Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Nilotinib is to be taken empty stomach. Administration: 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. Adult Dose: Oral Chronic Myeloid Leukemia (CML), Newly Diagnosed Indicated for initial treatment of newly diagnosed Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML) 300 mg PO q12hr Chronic Myeloid Leukemia (CML), Resistant/Intolerant Indicated for treatment of chronic phase and accelerated pase Ph+ CML in patients resistant to or intolerant to prior therapy that included imatinib 400 mg PO q12hr Hepatic Impairment Newly diagnosed Ph+ CML (chronic phase at 300 mg BID) Mild, moderate, or severe hepatic impairment: Start initial dose at 200 mg BID; if tolerated, may increase to 300 mg BID Resistant or intolerant Ph+ CML (chronic phase or accelerated phase at 400 mg BID) Mild or moderate hepatic impairment: Start initial dose at 300 mg BID; if tolerated, may increase to 400 mg BID Severe hepatic impairment: Start initial dose at 200 mg BID; if tolerated, may increase to 300 mg BID, and then 400 mg BID Child Dose: <18 years old: Not recommended

Drugs that inhibit gastric acid secretion (e.g. PPIs) may reduce solubility and bioavailability of nilotinib. Potentially Fatal: Concomitant use w/ potent CYP3A4 inhibitors or antiarrhythmics (e.g. amiodarone, disopyramide, quinidine, sotalol, ketoconazole, clarithromycin, atazanavir) and other QT prolonging drugs (e.g. chloroquine, haloperidol, methadone, moxifloxacin, pimozide) may increase nilotinib serum levels and/or increase the risk of QT prolongation. Concomitant use w/ potent CYP3A4 inducers (e.g. rifampcin, phenobarbital, carbamazepine, phenytoin) may decrease nilotinib serum levels.

Patients with hypokalaemia, hypomagnaesemia or long QT syndrome. Pregnancy.

Common - Headache - Nausea - Abdominal pain - Rash - Itching - Hair loss - Muscle pain - Fatigue >10% Rash (33%),Headache (31%),Nausea (31%),Pruritus (29%),Fatigue (28%),Pyrexia (24%),Diarrhea (22%),Constipation (21%),Vomiting (21%),Arthralgia (18%),Cough (17%),Extremity pain (16%),Asthenia (14%),Muscle spasms (14%),Myalgia (14%),Abdominal pain (13%),Bone pain (13%),Back pain (12%),Dyspnea (11%),Nasopharyngitis (11%),Peripheral edema (11%) 1-10% (selected) Dizziness,Insomnia,Paresthesia,QT interval prolongation,HTN,Palpitations,QT interval prolongation,Hyperglycemia,Hyperkalemia,Hypomagnesemia,Neutropenia,Pancytopenia <1% Peripheral arterial occlusive disease,Tumor lysis syndrome,Aortic valve sclerosis,Abscess,Amnesia,Dehydration Potentially Fatal: QT prolongation and sudden deaths.

Precaution: Patient w/ history of pancreatitis, w/ total gastrectomy. Hepatic impairment. Maintain adequate hydration and correct uric acid levels, hypomagnesaemia, hypokalaemia and other electrolyte imbalances prior to therapy. Pregnancy and lactation. Monitoring Parameters Monitor ECG, CBC, hepatic function, serum lipase regularly. Monitor electrolyte periodically during therapy. Lactation: not known if excreted in breast milk; do not nurse

Nilotinib is a potent inhibitor of BCR-ABL tyrosine kinase. It binds to and stabilises the inactive conformation of the kinase domain of Abl protein.