Nilotinib

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

GNH USA supplies Nilotinib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with distribution originating from the European Union market. All batches meet EU GMP standards and are exported under controlled conditions, ensuring product quality and traceability.

Nilotinib targets malignant cells driven by BCR‑ABL and related kinases, making it a key therapy in specific blood cancers.

Chronic myeloid leukemia (CML) – chronic phase: controls leukemic cell proliferation and prolongs survival. CML – accelerated phase: reduces disease burden and delays progression. Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): induces remission and extends overall survival.

Common Side Effects: - Nausea: mild to moderate upset stomach. - Diarrhea: loose stools, often transient. - Rash: skin irritation or erythema. - Headache: mild to moderate intensity. - Fatigue: general tiredness. - Myalgia: muscle aches.

Serious or Rare Side Effects: - QT interval prolongation: may cause cardiac arrhythmias. - Pancreatitis: inflammation of the pancreas, presenting with abdominal pain. - Severe hepatic injury: elevated liver enzymes or hepatitis. - Grade 3/4 neutropenia: marked reduction in neutrophils. - Grade 3/4 thrombocytopenia: low platelet counts. - Anaphylactic reactions: rare but potentially life‑threatening hypersensitivity.

Nilotinib requires careful monitoring and patient education before and during therapy.

Cardiac monitoring: baseline ECG and periodic QT interval assessment due to risk of QT prolongation. Hepatic function: monitor liver enzymes because of potential hepatotoxicity. Pancreatic enzymes: check amylase/lipase periodically for pancreatitis risk. Blood counts: regular CBC to detect neutropenia or thrombocytopenia. Drug interactions: avoid concomitant strong CYP3A4 inhibitors. Pregnancy: contraindicated in pregnancy (Category D); advise effective contraception. Store at ambient temperature: keep tablets in 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. - QT‑prolonging agents (e.g., amiodarone, sotalol): additive risk of arrhythmia. - Antacids containing aluminum or magnesium: reduce nilotinib absorption.

Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin, phenytoin): may lower nilotinib levels. - Warfarin: potential alteration of INR, monitor coagulation. - Statins metabolized by CYP3A4 (e.g., simvastatin): increased statin exposure, consider dose adjustment. - Digoxin: possible increase in serum concentration, monitor levels.