Nilotinib Zentiva

Nilotinib, the active ingredient in Nilotinib Zentiva, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats chronic myeloid leukemia and Philadelphia chromosome‑positive acute lymphoblastic leukemia in adult patients. GNH USA supplies Nilotinib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Nilotinib is indicated for hematologic malignancies driven by the BCR‑ABL fusion protein.

- Chronic myeloid leukemia (CML): reduces disease progression and improves survival in chronic, accelerated, and blast phases. - Chronic myeloid leukemia (CML) after prior TKI therapy: provides an alternative option for patients who have failed or cannot tolerate other tyrosine kinase inhibitors. - Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): contributes to remission when used in combination with chemotherapy.

Common Side Effects: - Nausea - Diarrhea - Rash - Fatigue

Serious or Rare Side Effects: - QT interval prolongation - Pancreatitis - Severe liver enzyme elevation

Nilotinib requires careful monitoring and patient counseling before and during therapy. - ECG monitoring: obtain baseline and periodic ECGs to detect QT prolongation. - Liver function tests: assess hepatic enzymes before initiation and regularly during treatment. - Blood glucose monitoring: watch for hyperglycemia, especially in diabetic patients. - Pregnancy avoidance: drug is contraindicated in pregnancy (Category D); use effective contraception. - Store at ambient temperature: keep below 25°C in the original pack, protect from moisture.

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

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nilotinib exposure. - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): reduce nilotinib effectiveness. - Proton pump inhibitors and antacids that raise gastric pH: may lower nilotinib absorption. - Other QT‑prolonging agents (e.g., macrolide antibiotics, antiarrhythmics): increase risk of cardiac arrhythmia.

Moderate Interactions (Monitor Closely): - Warfarin: nilotinib can alter INR; monitor coagulation parameters. - Statins metabolized by CYP3A4 (e.g., simvastatin): may increase statin levels; consider dose reduction. - Digoxin: potential increase in serum digoxin; monitor levels and clinical response.