Nilotinib is a second-generation inhibitor targeting Bcr-Abl tyrosine kinase, primarily indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) who are resistant or intolerant to imatinib.
Precautions for Nilotinib Administration
Contraindication Screening and Baseline Assessment
Patients with uncorrected hypokalemia or hypomagnesemia.
Patients with congenital long QT syndrome.
Patients allergic to nilotinib or any component in the capsules.
Baseline Examination Requirements
Electrocardiogram (ECG): QTc interval must be evaluated before treatment.
Electrolyte testing: Including serum potassium, serum magnesium, serum calcium, etc.
Hematological testing: Complete blood count (CBC).
Liver function testing: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase.
Pancreatic function: Serum lipase and amylase.
Pregnant Women
Classified as Pregnancy Category D, with a confirmed risk of teratogenicity.
Women of childbearing age must use effective contraceptive measures during treatment and for 3 months after discontinuing the drug.
The effectiveness of hormonal contraceptives may be reduced; combined use of barrier contraception is recommended.
Lactating Women
The drug can be excreted in breast milk.
Breastfeeding is prohibited during treatment and for 2 months after the last dose.
Hepatic Impairment
No studies have been conducted in patients with hepatic impairment.
The drug should be used with caution and the QT interval should be closely monitored.
Elderly Patients
Efficacy may be reduced in elderly patients with accelerated-phase CML.
Enhanced cardiovascular monitoring is required.
Monitoring During Nilotinib Administration
Electrocardiogram Monitoring
7 days after the start of treatment.
After each dose adjustment.
Regular rechecks (determined clinically).
Management of abnormalities: If QTc prolongation is detected, electrolytes must be evaluated immediately.
Adjust the dose or discontinue the drug based on the QTc value.
Hematological Monitoring
First 2 months: CBC once every 2 weeks.
After that: Once a month or as clinically needed.
Biochemical Monitoring
Electrolytes: Regular monitoring of serum potassium, serum magnesium, and serum calcium.
Liver function: Regular monitoring of ALT, AST, and bilirubin.
Pancreatic function: Regular monitoring of lipase and amylase.
Adverse Reaction Monitoring
Myelosuppression: Anemia, neutropenia, thrombocytopenia.
QT prolongation: Symptoms such as palpitations, syncope.
Pancreatitis: Sudden upper abdominal pain accompanied by nausea and vomiting.
Hepatotoxicity: Manifestations such as jaundice, fatigue.
Electrolyte disorders: Especially hypokalemia and hypomagnesemia.
