Nilotinib

DEA Class; Rx

Common Brand Names; Tasigna

• Antineoplastics, Tyrosine Kinase Inhibitor

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

Nilotinib 

capsule

• 150mg
• 200mg