Nilotinib Teva (Nilotinib)

Nilotinib targets the BCR‑ABL driven pathway in chronic myeloid leukemia, providing disease control across its phases.

• Chronic myeloid leukemia (chronic phase): reduces leukemic cell burden and helps achieve cytogenetic and molecular remission.
• Chronic myeloid leukemia (accelerated phase): improves disease control and delays progression.
• Chronic myeloid leukemia (blast phase): contributes to reduction of blast cells and supports remission when combined with other therapies.

• Nilotinib selectively binds to the ATP‑binding site of the BCR‑ABL fusion protein, inhibiting its tyrosine kinase activity. By preventing phosphorylation of downstream substrates, it blocks signaling pathways that drive proliferation and survival of leukemic cells. The drug also inhibits related kinases such as KIT and PDGFR, enhancing its antileukemic effect while sparing normal hematopoietic cells.

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

Common Side Effects

• Nausea
• Diarrhea
• Rash
• Headache
• Fatigue
• Arthralgia

Serious or Rare Side Effects

• QT interval prolongation and cardiac arrhythmias
• Arterial occlusive events (e.g., peripheral arterial disease)
• Severe liver injury (hepatitis, elevated transaminases)
• Pancreatitis
• Severe skin reactions (Stevens‑Johnson syndrome, toxic epidermal necrolysis)
• Tumor lysis syndrome

When prescribing nilotinib, clinicians should observe several precautionary measures to minimize risk.

• Monitor cardiac function: obtain baseline ECG and repeat periodically to detect QT prolongation.
• Assess hepatic function: check liver enzymes before initiation and during therapy.
• Check electrolyte levels: especially potassium and magnesium, correcting abnormalities before treatment.
• Avoid strong CYP3A4 inhibitors: concomitant use may increase nilotinib exposure and toxicity.
• Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture.

Nilotinib interacts with several medicines; understanding the interaction level guides clinical management.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may markedly increase plasma concentrations.
• Antacids containing aluminum or magnesium: reduce nilotinib absorption if taken simultaneously.
• QT‑prolonging agents (e.g., sotalol, amiodarone): increase risk of serious cardiac arrhythmias.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower nilotinib exposure and reduce efficacy.
• Warfarin: may require closer INR monitoring due to potential interaction.
• Statins metabolized by CYP3A4 (e.g., simvastatin, lovastatin): monitor for myopathy and adjust dose if needed.