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Nilotinib

    Brands

    DEA Class; Rx

    Common Brand Names; Tasigna

    • Antineoplastics, Tyrosine Kinase Inhibitor

    BCR-ABL tyrosine kinase inhibitor
    Used in certain types of Philadelphia chromosome-positive chronic myelogenous leukemia
    May cause QT prolongation; sudden death has been reported

    Indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML).

    Long QT syndrome, hypokalemia, hypomagnesemia

    • 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%)

    Grade 3/4 thrombocytopenia, neutropenia and anemia may occur; perform complete blood cell counts (CBC) every 2 weeks for first 2 months and then monthly thereafter, or as clinically indicated; myelosuppression was generally reversible and usually managed by withholding drug temporarily or dose reduction

    Sudden deaths reported; ventricular repolarization abnormalities may have contributed to their occurrence; evaluate cardiovascular status and monitor/manage cardiovascular risk factors during therapy

    QT interval reported; significant prolongation of the QT interval may occur when drug is inappropriately taken with food; avoid taking with food; prolongation of the QT interval can result in torsade de pointes, which may result in syncope, seizure, and/or death

    May cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia; correct hypokalemia or hypomagnesemia before administration; monitor periodically during therapy

    Cardiovascular events (eg, ischemic heart disease, peripheral arterial occlusive disease, ischemic cerebrovascular events) reported in patients with newly diagnosed Ph+ CML; evaluate cardiovascular status, monitor cardiovascular risk factors, and manage during therapy

    Use caution in history of pancreatitis; monitor serum lipase monthly or as clinically indicated; in case lipase elevations are accompanied by abdominal symptoms, interrupt doses and consider appropriate diagnostics to exclude pancreatitis

    Use caution in hepatic impairment; monitor hepatic function tests (HFTs) monthly or as clinically indicated; reduce dose and monitor QT interval

    No available data in pregnant women to inform the drug-associated risk

    No data are available regarding the presence of nilotinib or its metabolites in human milk or its effects on a breastfed child or on milk production

    Adults

    800 mg/day PO.

    Geriatric

    800 mg/day PO.

    Adolescents

    230 mg/m2 twice daily, not to exceed 400 mg/dose.

    Children

    230 mg/m2 twice daily, not to exceed 400 mg/dose.

    Infants

    Safety and efficacy have not been established.

    Nilotinib 

    capsule

    • 150mg
    • 200mg