Monograph Details
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Neoplasms
> Kinase inhibitors
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TASIGNA |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Kinase inhibitor. |
| Generic Name |
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Nilotinib (as HCl monohydrate) 200mg; caps; contains lactose. |
| Indications |
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Chronic and accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adults resistant or intolerant to imatinib. |
| Children |
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Not recommended. |
| Adults |
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Swallow whole. 400mg every 12 hours. See literature for dose adjustments for QT prolongation, hematological and non-hematological toxicities, concomitant strong CYP3A4 inhibitors and inducers. |
| Contraindications |
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Hypokalemia. Hypomagnesemia. Long QT syndrome. |
| Precautions |
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Hereditary galactose intolerance, severe lactase deficiency, glucose-galactose malabsorption: not recommended. Correct electrolyte abnormalities before starting; monitor. Hepatic impairment. History of pancreatitis. Uncontrolled cardiovascular or renal disease. Monitor CBCs every 2 weeks for 1st 2 months then once monthly; monitor ECG at baseline, after 7 days, then periodically and after dose changes. Monitor serum lipase, liver function. Pregnancy (Cat.D) (use adequate contraception), nursing mothers: not recommended. |
| Interactions |
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Avoid drugs that can cause QT prolongation. Avoid strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole), grapefruit. Avoid strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, phenobarbital), St. John's wort; adjust nilotinib dose if unavoidable. May affect, or be affected by, other drugs metabolized by CYP3A4, 2C8, 2C9, 2D6, UGT1A1, p-glycoprotein. |
| Adverse Reactions |
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Rash, pruritus, GI upset, fatigue, headache, constipation, reversible myelosuppression (thrombocytopenia, neutropenia, anemia), pneumonia, febrile neutropenia, intracranial hemorrhage, elevated serum lipase, pyrexia, electrolyte disturbances (hypophosphatemia, hypo- and hyperkalemia, hypocalcemia, hyponatremia); QT prolongation, arrhythmias, sudden death, hepatotoxicity. |
| How Supplied |
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Caps—28 |
| Additional Resources |
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• Related Prescribing Note |
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