Nilotinib

Nilotinib, the active ingredient in Nilotinib, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats chronic myeloid leukemia in the chronic phase and Philadelphia chromosome‑positive acute lymphoblastic leukemia in patients whose disease is driven by the BCR‑ABL fusion protein.

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

Nilotinib is a targeted oral therapy used in BCR‑ABL driven leukemias. - Chronic myeloid leukemia (CML) in chronic phase: reduces malignant cell proliferation and improves long‑term survival. - Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): provides disease‑specific inhibition of BCR‑ABL signaling. - Other BCR‑ABL positive leukemias: offers a targeted option where the fusion protein is present.

Adverse reactions may vary in frequency and severity.

Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Diarrhea: loose stools that may require fluid replacement. - Rash: skin erythema or pruritus. - Elevated liver enzymes: mild transaminase increases. - Fatigue: generalized tiredness.

Serious or Rare Side Effects: - Cardiovascular events: including arterial occlusion or ischemia. - Pancreatitis: severe abdominal pain with elevated enzymes. - Severe hepatic injury: marked elevation of bilirubin or transaminases. - QT interval prolongation: risk of cardiac arrhythmias.

Nilotinib requires careful monitoring and patient counseling. - Cardiac assessment: evaluate baseline ECG and monitor QT interval. - Hepatic function: check liver enzymes before and during therapy. - Pancreatic enzymes: monitor amylase and lipase periodically. - Drug interactions: avoid concomitant strong CYP3A4 inhibitors. - Pregnancy and lactation: use only if benefits outweigh potential risks; discuss with a specialist. - Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture and direct sunlight.

Nilotinib may interact with several drug classes, altering its efficacy or safety.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): can markedly increase nilotinib plasma levels. - Proton pump inhibitors: may reduce absorption and lower effectiveness.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): may decrease nilotinib exposure. - Antacids containing aluminum or magnesium: can affect gastric pH and drug absorption. - Anticoagulants (e.g., warfarin): may require INR monitoring due to potential pharmacodynamic changes.