Tasigna Disease Interactions

Nilotinib can cause increases in serum lipase. Patients with a previous history of pancreatitis might be at increased risk and should be monitored carefully for lipase elevations and any abdominal symptoms. Serum lipase should be monitored monthly or as clinically indicated and treatment might need to be interrupted until pancreatitis is excluded as a diagnosis.

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Nilotinib should not be used in patients with hypokalemia, hypomagnesemia or long QT syndrome, as it has shown to prolong QT interval in a concentration-dependent manner. This can cause a ventricular tachycardia called Torsade de Pointes which can result in syncope, seizures, and/or death. Before initiating nilotinib, electrolytes should be tested. Hypokalemia or hypomagnesemia should be corrected before starting treatment and monitored periodically. Patients at risk should be monitored with an EKG before and during treatment as clinically indicated and dose adjustments might be needed.

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Cardiovascular events, including arterial vascular occlusive events, peripheral arterial occlusive events and ischemic cerebrovascular events have been reported in patients receiving tyrosine kinase inhibitors. If acute signs or symptoms of cardiovascular events occur, patients should seek immediate medical attention. The cardiovascular status and risk factors of patients should be evaluated prior to therapy and cardiovascular monitoring and management should take place during treatment.

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Fluid retention occurs with BCR-ABL tyrosine kinase inhibitors therapy and may manifest as pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Caution should be taken when using these drugs in patients with preexisting fluid retention or congestive heart failure. Monitor and manage patients using standards of care. Interrupt, reduce dose or discontinue therapy as necessary.

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Thrombocytopenia, aplastic anemia, agranulocytosis and neutropenia occur with BCR-ABL tyrosine kinase inhibitors. Therapy with these drugs should be administered cautiously in patients with preexisting bone marrow suppression. A complete blood count should be performed every 1-2 weeks for the first month of therapy and then monthly thereafter, or as clinically indicated. To manage myelosuppression, withhold, reduce dose, or discontinue therapy as necessary.

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Nilotinib can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Electrolyte abnormalities should be corrected prior to initiating nilotinib and during therapy, and should be monitored periodically.

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Nilotinib exposure is increased in patients with hepatic impairment. The use of a lower starting dose might be needed. Additionally, there have been reports of hepatotoxicity as measured by elevations in bilirubin, AST, ALT and alkaline phosphatase. Liver function should be monitored before initiation of treatment and regularly during therapy. Dose reduction or interruption might be needed if laboratory abnormalities are found.

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Nilotinib capsules contain lactose, so it is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency with a severe degree of intolerance to lactose- containing products, or of glucose-galactose malabsorption.

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