Nilotinib Teva (Nilotinib)

Nilotinib is a targeted therapy used in the management of chronic myeloid leukemia, a BCR‑ABL driven hematologic malignancy.

• Chronic Myeloid Leukemia (chronic phase): Improves hematologic, cytogenetic and molecular response rates.
• Accelerated Phase CML: Provides disease control when prior tyrosine kinase inhibitors are ineffective.
• Philadelphia chromosome‑positive CML after imatinib intolerance: Offers an alternative therapeutic option for patients who cannot tolerate first‑line therapy.

• Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase by binding to its ATP‑binding site, thereby blocking downstream signaling pathways that promote leukemic cell proliferation and survival. It also inhibits related kinases such as KIT and PDGFR, contributing to its antineoplastic activity in chronic myeloid leukemia.

Common Side Effects

• Nausea: mild to moderate gastrointestinal upset.
• Diarrhea: loose stools, often transient.
• Rash: skin erythema or pruritus.
• Headache: mild to moderate intensity.
• Fatigue: generalized tiredness.
• Myalgia: muscle aches.

Serious or Rare Side Effects

• QT interval prolongation: risk of cardiac arrhythmia.
• Arterial occlusive events: including peripheral arterial disease.
• Pancreatitis: abdominal pain with elevated enzymes.
• Hepatic toxicity: elevated transaminases or bilirubin.
• Severe neutropenia: increased infection risk.
• Tumor lysis syndrome: metabolic disturbances after rapid cell death.

Nilotinib requires careful monitoring and patient education before and during therapy.

• Monitor cardiac function: obtain baseline ECG and repeat periodically due to QT prolongation risk.
• Assess liver function: check hepatic enzymes before initiation and during treatment.
• Check blood counts: regular CBC to detect neutropenia or thrombocytopenia.
• Avoid strong CYP3A4 inhibitors: concomitant use may raise nilotinib plasma levels.
• Pregnancy and lactation: contraindicated unless benefits outweigh potential risks.
• Store at room temperature: keep in original container, protect from moisture and light.

Nilotinib may interact with several concomitant medications, requiring dose adjustments or avoidance.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): can markedly increase nilotinib exposure.
• QT‑prolonging agents (e.g., amiodarone, fluoroquinolones): additive risk of cardiac arrhythmias.
• Antacids containing aluminum or magnesium: may reduce nilotinib absorption.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic levels.
• Warfarin: potential alteration of INR, requiring closer coagulation monitoring.
• Statins metabolized by CYP3A4 (e.g., simvastatin): increased risk of myopathy.
• Diuretics causing hypokalemia: may exacerbate QT prolongation.
• Oral contraceptives: possible reduced efficacy, advise additional contraception.