1. Aschenbrenner, Diane S. MS, APRN-BC


* Nilotinib (Tasigna) is now ap-proved for use in the early stages of Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia.


* As with its previous use in late-stage disease, follow-up blood work and electrocardiography are necessary.



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Nilotinib (Tasigna), an oral chemotherapeutic agent, has been approved by the Food and Drug Administration (FDA) to treat adult patients at earlier stages of Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia than previously allowed. The drug was originally approved for use in 2007 to treat the condition in adult patients whose disease had progressed or who couldn't tolerate other therapies, including imatinib (Gleevec). Nilotinib received the new indication under the FDA's accelerated approval program, and the drug company is required to collect additional long-term efficacy and safety information in order to keep the indication.


This slowly progressing blood and bone marrow disease is linked to a genetic abnormality. In any chronic myeloid leukemia, there's an overproduction of granulocytes (a type of white blood cell), although these granulocytes are abnormal and don't become healthy cells. They also crowd out functioning white cells, as well as red blood cells and platelets.


Nilotinib is known to increase the risk of cardiac QT prolongation, as well as to cause significant myelosuppression (thrombocytopenia, anemia, and neutropenia). Because of these effects, a medication guide accompanies all filled prescriptions, to help patients recognize early indications of complications. Whether nilotinib is used early or late in the treatment of this cancer, the adverse-effects profile is the same. The most common nonhematologic adverse effects are rash, pruritus, headache, nausea, fatigue, and myalgia.


Nurses should teach patients the importance of follow-up blood work to monitor blood cell counts and electrocardiograms to assess for QT prolongation. Patients should also be warned not to crush or chew the nilotinib capsules, not to consume grapefruit or grapefruit juice, and not to take the drug with food, as doing any of these will create a higher-than-normal circulating level of nilotinib, which increases the risk of adverse effects. Nurses should also advise patients to read the medication guide that accompanies each new prescription because it may contain new information.