Nilotinib Teva (Nilotinib)

• Nilotinib is a targeted therapy used in the treatment of BCR‑ABL positive leukemias.
• Chronic Myeloid Leukemia (CML) in chronic phase: reduces leukemic cell proliferation and improves survival.
• Philadelphia‑positive CML: selectively blocks the BCR‑ABL kinase driving disease activity.
• CML after imatinib resistance: provides an alternative oral tyrosine‑kinase inhibition strategy.

• Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, a fusion protein that drives uncontrolled cell growth in chronic myeloid leukemia. By binding to the ATP‑binding site of the kinase, it blocks downstream signaling pathways responsible for proliferation and survival of leukemic cells, leading to apoptosis and disease control.

Nilotinib may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

• Nausea: mild to moderate gastrointestinal upset.
• Diarrhea: loose stools that may require fluid replacement.
• Rash: skin irritation or erythema.
• Fatigue: persistent feeling of tiredness.

Serious or Rare Side Effects

• Cardiovascular events: arterial occlusive disease or ischemia.
• Pancreatitis: inflammation of the pancreas with abdominal pain.
• QT interval prolongation: heart rhythm disturbance that can lead to arrhythmia.
• Severe liver injury: marked elevation of liver enzymes and possible hepatitis.

Before initiating therapy, clinicians should assess several safety parameters.

• Cardiac monitoring: evaluate baseline ECG and cardiovascular risk factors.
• Liver function: check hepatic enzymes and monitor for signs of hepatitis.
• Blood glucose: monitor for hyperglycemia, especially in diabetic patients.
• Hypersensitivity: discontinue if severe allergic reactions occur.
• Renal impairment: adjust dosing and monitor renal function as needed.
• Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Nilotinib can interact with other medicines, altering its effectiveness or safety.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib exposure.
• Antacids containing aluminum or magnesium: reduce absorption of nilotinib.
• St. John's wort (CYP3A4 inducer): can markedly lower nilotinib levels.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may require dose adjustment.
• Anticoagulants (e.g., warfarin): monitor coagulation parameters.
• Antidiabetic agents (e.g., insulin, sulfonylureas): watch for changes in blood glucose.