Nilotinib Viatris

Nilotinib, the active ingredient in Nilotinib Viatris, is a tyrosine kinase inhibitor presented as a tablet for oral use. It is indicated for the treatment of chronic myeloid leukemia in patients with the Philadelphia chromosome‑positive disease.

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

Nilotinib targets BCR‑ABL‑positive leukemias, primarily chronic myeloid leukemia.

- Chronic Myeloid Leukemia (CML): Reduces proliferation of Philadelphia chromosome‑positive leukemic cells and helps achieve cytogenetic and molecular remission.

Common Side Effects: - Rash or skin irritation - Nausea or vomiting - Diarrhea - Elevated liver enzymes - Fatigue or weakness - Muscle cramps or pain

Serious or Rare Side Effects: - Cardiovascular events such as arterial occlusion or ischemia - Severe hepatotoxicity - Pancreatitis - QT interval prolongation leading to arrhythmia - Severe hypersensitivity reactions - Tumor lysis syndrome

Nilotinib requires careful monitoring and patient education before initiation. - Cardiac assessment: Evaluate baseline ECG and cardiovascular risk factors. - Hepatic function: Check liver enzymes and adjust use if significant elevation occurs. - Electrolytes: Monitor serum potassium, magnesium, and calcium to reduce QT prolongation risk. - Drug interactions: Review concomitant medications that affect CYP3A4 or QT interval. - Pregnancy and lactation: Avoid use unless benefits outweigh potential risks. - Store at ambient temperature: Keep below 25°C in the original container, protect from moisture and light.

Nilotinib may interact with several drug classes that alter its metabolism or cardiac safety.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) – may markedly reduce nilotinib exposure. - QT‑prolonging agents (e.g., macrolide antibiotics, antiarrhythmics) – increase risk of serious arrhythmias. - Antacids containing aluminum or magnesium – can decrease nilotinib absorption.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin) – may increase plasma levels. - Statins metabolized by CYP3A4 (e.g., simvastatin) – monitor for myopathy. - Warfarin – observe INR more frequently due to potential interaction.