Nilotinib Teva (Nilotinib)

Nilotinib is indicated for the treatment of Philadelphia chromosome‑positive chronic myeloid leukemia, targeting the BCR‑ABL tyrosine kinase pathway.

• Chronic myeloid leukemia (CML) – chronic phase: reduces leukemic cell proliferation and improves hematologic response.
• CML – accelerated phase: helps achieve cytogenetic and molecular remission in advanced disease.
• CML after imatinib resistance or intolerance: provides an alternative targeted therapy for patients who have not responded to first‑line treatment.

• Nilotinib selectively binds to the ATP‑binding pocket of the BCR‑ABL tyrosine kinase, blocking its activity and downstream signaling that drives uncontrolled proliferation of leukemic cells. It also inhibits related kinases such as KIT and PDGFR, contributing to antineoplastic effects. By preventing phosphorylation events, the drug induces apoptosis and limits growth of Philadelphia chromosome‑positive malignant clones.

Nilotinib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

• Nausea
• Diarrhea
• Rash
• Fatigue
• Myalgia

Serious or Rare Side Effects

• QT interval prolongation leading to cardiac arrhythmia
• Severe hepatotoxicity with elevated liver enzymes
• Pancreatitis
• Grade 3/4 neutropenia or thrombocytopenia

When prescribing Nilotinib, clinicians should observe several safety precautions to minimize risk.

• Cardiac monitoring: assess baseline ECG and monitor QT interval during therapy.
• Hematologic monitoring: perform regular complete blood counts to detect neutropenia or thrombocytopenia.
• Liver function: check hepatic enzymes periodically for signs of toxicity.
• Drug interactions: avoid concomitant strong CYP3A4 inhibitors and QT‑prolonging agents.
• Electrolyte balance: correct hypokalemia, hypomagnesemia, and hypocalcemia before treatment.
• Store at room temperature: keep tablets in original container, protect from moisture and light.

Nilotinib interacts with several medicines; understanding the level of interaction guides safe co‑administration.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase Nilotinib exposure and toxicity.
• QT‑prolonging drugs (e.g., amiodarone, sotalol): raise risk of cardiac arrhythmias.
• Antacids containing aluminum or magnesium: reduce absorption of Nilotinib.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may require dose adjustment.
• CYP3A4 inducers (e.g., rifampin, carbamazepine): can lower Nilotinib levels and reduce efficacy.
• Warfarin: monitor INR as Nilotinib may affect anticoagulant effect.
• Diuretics affecting electrolytes: maintain normal potassium, magnesium to avoid QT issues.