Drug Index


Mechanism :

Nilotinib is a selective tyrosine kinase inhibitor that targets BCR-ABL kinase, c-KIT and platelet derived growth factor receptor (PDGFR).

Indication :

  • Chronic myelogenous leukemia
  • Off-label:
  • Acute lymphoblastic leukemia (ALL)
  • Philadelphia chromosome-positive (Ph+)
  • Gastrointestinal stromal tumor (GIST) (refractory)

Contraindications :

Hypersensitivity to nilotinib or any component of the formulation; persistent QTc >48 msec, Hypokalemia, hypomagnesemia, or long QT syndrome.

Dosing :

≥1 year
230 mg/m2 twice daily (rounded to the nearest 50 mg dose); Maximum: 400 mg (as a single dose) twice daily.

Adverse Effect :

Rash, headache, nausea, pruritus, fatigue, fever, diarrhea, constipation, vomiting, arthralgia, cough, extremity pain, asthenia, muscle spasms, myalgia, abdominal pain, bone pain, back pain, dyspnea, nasopharyngitis, peripheral edema, dizziness, QTc prolongation, hyperglycemia, hyperkalemia, hypomagnesemia, neutropenia, pancytopenia, Hepatitis B virus reactivation, Thrombotic microangiopathy.

Interaction :

Antacids: May decrease the serum concentration of Nilotinib.
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents.
CYP3A4 Inducers: May decrease the serum concentration of Nilotinib.
CYP3A4 Inhibitors: May increase the serum concentration of Nilotinib.
QT-prolonging Agents: May enhance the QTc-prolonging effect of Nilotinib.
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of live vaccines.

Hepatic Dose :

Hepatotoxicity occurring during treatment:
If elevated ALT or AST = 5 times upper limit of normal (ULN) or bilirubin elevation is = 1.5 times ULN: Withhold treatment and monitor transaminases or bilirubin. When ALT or AST returns to < 2.5 times ULN or bilirubin returns to = 1.5 times ULN, resume treatment at 230 mg/m2 once daily (if previous dose was 230 mg/m2 twice daily). If previous dose was already 230 mg/m2 once daily and recovery to = grade 1 was longer than 28 days, discontinue treatment.
If elevated bilirubin
11/02/2020 20:01:48 Nilotinib
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