Nilotinib Zentiva (Nilotinib)

• Nilotinib targets the BCR‑ABL driven pathway in myeloid and lymphoid malignancies.
• Chronic myeloid leukemia (CML): reduces leukemic cell proliferation and helps achieve disease control.
• Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): induces remission and improves survival rates.
• Accelerated or blast phase CML: extends overall survival in advanced disease stages.

• Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, preventing its phosphorylation activity and downstream signaling that drives uncontrolled proliferation of leukemic cells. By blocking this oncogenic pathway, the drug restores normal cellular regulation and reduces malignant clone expansion.

Common Side Effects

• Nausea
• Diarrhea
• Rash or skin irritation
• Headache
• Fatigue
• Musculoskeletal pain

Serious or Rare Side Effects

• Cardiovascular events such as arterial occlusion or ischemic heart disease
• Pancreatitis
• Severe liver injury (hepatitis, elevated transaminases)
• QT interval prolongation leading to arrhythmia
• Stevens‑Johnson syndrome or toxic epidermal necrolysis
• Severe infections requiring hospitalization

• Before and during therapy, clinicians should monitor several safety parameters.
• Monitor cardiac function: obtain baseline ECG and repeat periodically.
• Assess liver function: check transaminases before initiation and during treatment.
• Check pancreatic enzymes: monitor amylase and lipase for signs of pancreatitis.
• Evaluate QT interval: correct electrolyte disturbances and avoid concurrent QT‑prolonging drugs.
• Avoid use in pregnancy: drug is classified as Category D and should not be used unless benefits outweigh risks.
• Store at ambient temperature: keep below 25°C, retain in original packaging, and protect from moisture.

Nilotinib has several clinically significant drug interactions that require careful management.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) – may raise plasma levels.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) – may reduce efficacy.
• Antacids containing aluminum or magnesium – can impair absorption.
• QT‑prolonging agents (e.g., sotalol, amiodarone) – increase risk of arrhythmia.
• Concomitant warfarin – may enhance anticoagulant effect and bleeding risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin).
• Moderate CYP3A4 inducers (e.g., phenytoin, phenobarbital).
• H2‑blockers (e.g., ranitidine, famotidine) – may modestly affect bioavailability.
• Statins metabolized by CYP3A4 (e.g., simvastatin, lovastatin) – consider dose adjustment.
• Diuretics causing electrolyte shifts – monitor potassium and magnesium to prevent QT prolongation.