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 in patients who are Philadelphia chromosome‑positive.

GNH USA supplies Nilotinib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Nilotinib is a targeted therapy used in the management of chronic myeloid leukemia, a disease driven by the BCR‑ABL tyrosine‑kinase pathway. - Chronic myeloid leukemia (chronic phase): reduces leukemic cell proliferation in Philadelphia chromosome‑positive patients. - Chronic myeloid leukemia (accelerated phase): helps achieve hematologic and cytogenetic responses. - Chronic myeloid leukemia (blast phase): provides disease control when combined with other agents.

Adverse reactions may vary in frequency and severity.

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: - Pancreatitis: abdominal pain with elevated enzymes. - Severe liver injury: jaundice, elevated transaminases. - QT interval prolongation: risk of cardiac arrhythmia. - Severe neutropenia: marked reduction in white blood cells. - Severe thrombocytopenia: low platelet counts leading to bleeding. - Cardiac failure: signs of reduced cardiac output.

Patients should be monitored closely for safety concerns before and during therapy. - ECG monitoring: assess QT interval prior to initiation and periodically. - Liver function tests: check baseline and follow‑up enzymes. - Hematology monitoring: regular complete blood counts. - Avoid in known QT‑prolonging conditions: patients with congenital long QT or electrolyte disturbances. - Use caution in hepatic impairment: dose adjustment may be required. - Store at below 25°C: keep in the original pack, protect from moisture.

Nilotinib may interact with several concomitant medicines, altering its efficacy or safety.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nilotinib exposure. - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic levels. - QT‑prolonging agents (e.g., amiodarone, sotalol): additive risk of cardiac arrhythmia. - Antacids containing aluminum or magnesium: reduce absorption if taken simultaneously.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise concentrations. - H2‑blockers (e.g., ranitidine): can affect gastric pH and absorption. - Statins metabolized by CYP3A4 (e.g., simvastatin): monitor for increased statin levels. - Warfarin: potential alteration of anticoagulant effect, monitor INR.