Nilotinib Viatris

Nilotinib, the active ingredient in Nilotinib Viatris, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats chronic myeloid leukemia in the chronic phase. GNH USA supplies Nilotinib Viatris as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Nilotinib acts on the BCR‑ABL tyrosine‑kinase pathway, primarily used in chronic myeloid leukemia therapy.

- Chronic myeloid leukemia (CML) – chronic phase: reduces leukemic cell proliferation and improves survival. - Chronic myeloid leukemia (CML) – accelerated phase: provides disease control after prior therapy. - CML after imatinib resistance: offers an alternative targeted option for patients who have failed first‑line treatment.

Common Side Effects: - Nausea: mild to moderate stomach upset. - Diarrhea: loose stools, often transient. - Headache: mild to moderate intensity. - Rash: skin erythema or pruritus.

Serious or Rare Side Effects: - Cardiovascular events: myocardial infarction or ischemic heart disease. - QT interval prolongation: risk of serious arrhythmias. - Pancreatitis: abdominal pain with elevated enzymes. - Severe hepatic injury: jaundice, elevated transaminases.

Nilotinib requires careful monitoring due to its targeted activity and potential systemic effects. - Cardiac monitoring: assess baseline ECG and periodic follow‑up. - QT interval assessment: avoid concomitant QT‑prolonging drugs. - Liver function tests: monitor transaminases regularly. - Blood glucose: watch for hyperglycemia, especially in diabetic patients. - Drug interactions: review concomitant CYP3A4 modulators. - Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

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

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nilotinib exposure. - Concomitant QT‑prolonging agents (e.g., amiodarone, sotalol): heighten risk of arrhythmia.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may modestly raise levels. - Antacids containing aluminum or magnesium: can reduce oral absorption. - CYP3A4 inducers (e.g., rifampin, St. John’s wort): may lower drug concentrations.