Nilotinib Stada

Nilotinib, the active ingredient in Nilotinib Stada, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It treats chronic myeloid leukemia in adult patients.

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

Nilotinib is a targeted therapy that acts on the BCR‑ABL tyrosine‑kinase pathway in chronic myeloid leukemia.

- Chronic phase CML: helps achieve and maintain cytogenetic and molecular remission. - Accelerated phase CML: provides disease control when resistance to prior therapy occurs. - Blast phase CML: used as part of combination therapy to reduce leukemic burden.

Common Side Effects: - Nausea: mild to moderate upset stomach. - Diarrhea: loose stools that may be transient. - Rash: skin erythema or pruritus. - Fatigue: feeling unusually tired. - Headache: mild to moderate head discomfort. - Myalgia: muscle aches.

Serious or Rare Side Effects: - QT interval prolongation: can lead to cardiac arrhythmias. - Pancreatitis: inflammation of the pancreas. - Severe hepatic injury: marked elevation of liver enzymes. - Stevens‑Johnson syndrome or toxic epidermal necrolysis: severe skin reactions. - Thrombocytopenia: low platelet count increasing bleeding risk. - Arterial occlusive events: such as peripheral arterial disease.

Nilotinib requires careful monitoring and patient education before and during therapy. - Cardiac monitoring: obtain baseline ECG and repeat periodically to detect QT prolongation. - Liver function: check hepatic enzymes before initiation and during treatment. - Hematology: monitor complete blood counts for cytopenias. - Drug interactions: avoid concomitant strong CYP3A4 inhibitors or inducers. - Pregnancy and lactation: assess risk‑benefit; use only if clearly needed. - Store at room temperature: keep in the original container, protect from moisture and light.

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

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib exposure. - Strong CYP3A4 inducers (e.g., rifampin, phenytoin): may reduce efficacy. - Concomitant QT‑prolonging agents (e.g., amiodarone, fluoroquinolones): heighten risk of arrhythmia.

Moderate Interactions (Monitor Closely): - Antacids or proton‑pump inhibitors that raise gastric pH: may reduce absorption. - Warfarin or other anticoagulants: may require INR monitoring and dose adjustment.