Nilotinib Viatris

Nilotinib, the active ingredient in Nilotinib Viatris, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It treats chronic myeloid leukemia and Philadelphia chromosome‑positive acute lymphoblastic leukemia in adult patients.

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

Nilotinib is a tyrosine kinase inhibitor used in the treatment of hematologic malignancies driven by the BCR‑ABL fusion protein.

- Chronic myeloid leukemia (CML): reduces leukemic cell proliferation and helps achieve molecular remission. - Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): contributes to disease control and improves survival outcomes. - BCR‑ABL inhibitor‑resistant CML: provides an alternative therapeutic option when prior TKIs are ineffective.

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

Serious or Rare Side Effects: - Cardiovascular events such as QT interval prolongation or arterial occlusion - Hepatotoxicity manifested by elevated liver enzymes - Severe skin reactions, including Stevens‑Johnson syndrome or toxic epidermal necrolysis

Nilotinib requires careful monitoring and patient education before and during therapy. - Cardiac monitoring: assess ECG and QT interval before initiation and periodically thereafter. - Liver function: check hepatic enzymes regularly to detect potential hepatotoxicity. - Drug interactions: avoid concomitant use of strong CYP3A4 inhibitors that may raise nilotinib levels. - Pregnancy: contraindicated unless benefits outweigh risks; limited safety data are available. - Patient education: inform patients to report signs of infection, rash, or cardiac symptoms promptly. - Store at ambient temperature: keep below 25 °C, retain original packaging, and protect from moisture.

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

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nilotinib exposure and toxicity risk. - Antacids with high pH (e.g., aluminum hydroxide): markedly reduce nilotinib absorption, compromising efficacy.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower plasma concentrations. - Proton pump inhibitors: can modestly decrease absorption; monitor therapeutic response. - Warfarin: nilotinib may enhance anticoagulant effect; check INR more frequently.