Nilotinib Teva (Nilotinib)

Nilotinib is a targeted therapy that inhibits the BCR‑ABL tyrosine kinase pathway in chronic myeloid leukemia.

• Chronic myeloid leukemia (chronic phase): reduces leukemic cell proliferation and improves hematologic response.
• Chronic myeloid leukemia (accelerated phase): achieves disease control where prior therapies have failed.
• Chronic myeloid leukemia (blast phase): provides a therapeutic option for advanced disease.

• Nilotinib selectively binds to the ATP‑binding site of the BCR‑ABL fusion protein, preventing its kinase activity. By blocking downstream signaling cascades such as the RAS‑RAF‑MEK‑ERK and PI3K‑AKT pathways, the drug inhibits proliferation and induces apoptosis of leukemic cells that depend on BCR‑ABL signaling.

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

Common Side Effects

• Nausea: mild to moderate gastrointestinal upset.
• Diarrhea: watery stools often occurring early in therapy.
• Rash: erythematous skin lesions, usually self‑limiting.
• Fatigue: generalized tiredness without clear cause.
• Headache: transient cranial discomfort.
• Myalgia: muscle aches, especially in the limbs.

Serious or Rare Side Effects

• QT interval prolongation: can lead to cardiac arrhythmias.
• Pancreatitis: inflammation of the pancreas requiring medical attention.
• Hepatic toxicity: elevated liver enzymes or hepatitis.
• Severe neutropenia: marked reduction in neutrophil count.
• Severe thrombocytopenia: low platelet levels increasing bleeding risk.
• Cardiovascular events: myocardial infarction or stroke.

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

• Cardiac monitoring: obtain baseline ECG and monitor QT interval regularly.
• QT prolongation: avoid concomitant drugs that lengthen QT and correct electrolyte abnormalities.
• Hepatic function: assess liver enzymes before initiation and periodically thereafter.
• Pancreatic enzymes: monitor amylase and lipase levels during treatment.
• Store at ambient temperature: keep in the original container, protect from moisture and light.

Nilotinib interacts with several medicines that can alter its efficacy or safety.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib exposure.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic levels.
• Proton pump inhibitors or H2‑blockers: decrease nilotinib absorption by raising gastric pH.

Moderate Interactions (Monitor Closely)

• CYP3A4 substrate drugs (e.g., midazolam, tacrolimus): may require dose adjustment.
• Anticoagulants (e.g., warfarin): monitor INR more frequently due to potential interaction.