Active Substance: Nilotinib (as HCl H2O).
Overview
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This medicine contains an important and useful components, as it consists of
Nilotinib (as HCl H2O)is available in the market in concentration
Nilotinib
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
Chronic myelogenous leukaemia
Patients with hypokalaemia, hypomagnaesemia or long QT syndrome. Pregnancy.
>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.
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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.
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.
Information not available