Nilotinib Stada

Nilotinib, the active ingredient in Nilotinib Stada, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It selectively inhibits the BCR‑ABL kinase and is indicated for the treatment of chronic myeloid leukemia in adult patients.

GNH USA supplies Nilotinib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across markets.

Nilotinib acts on the BCR‑ABL tyrosine kinase pathway, a driver of chronic myeloid leukemia.

Chronic myeloid leukemia (chronic phase): achieves cytogenetic and molecular remission. Chronic myeloid leukemia (accelerated phase): reduces disease progression and improves survival. Chronic myeloid leukemia (blast phase): provides disease control when other TKIs are ineffective.

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

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

Serious or Rare Side Effects: - QT interval prolongation - Arterial occlusive events (e.g., peripheral arterial disease) - Pancreatitis - Severe hepatotoxicity - Severe neutropenia or other cytopenias

When prescribing Nilotinib, clinicians should observe several safety considerations.

Monitor cardiac function: baseline ECG and periodic checks due to QT prolongation risk. Assess liver enzymes: regular monitoring for hepatotoxicity. Check pancreatic enzymes: monitor for pancreatitis signs. Evaluate blood counts: watch for neutropenia and thrombocytopenia. Avoid concomitant strong CYP3A4 inhibitors: may increase drug exposure. Store at ambient temperature below 25°C: keep in original packaging, protect from moisture.

Nilotinib interacts with several medicines that affect its metabolism or cardiac safety.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): can markedly increase Nilotinib plasma levels. - Concomitant use with drugs that prolong QT interval (e.g., amiodarone, sotalol): may exacerbate cardiac risk. - Antacids or proton pump inhibitors that raise gastric pH (e.g., omeprazole): reduce Nilotinib absorption.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower Nilotinib exposure. - Statins metabolized by CYP3A4 (e.g., simvastatin): increased risk of statin‑related toxicity. - Warfarin: may require INR monitoring due to potential interaction.