Europe — EMA
Nilotinib Teva
GNH USA supplies Nilotinib Teva (Nilotinib), a tyrosine kinase inhibitor for chronic myeloid leukemia and Philadelphia chromosome‑positive CML.
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What is Nilotinib?
Nilotinib, the active ingredient in Nilotinib Teva, is a tyrosine kinase inhibitor presented as a tablet for oral use. It selectively blocks the BCR‑ABL enzyme, providing targeted therapy for chronic myeloid leukemia in patients whose disease carries the Philadelphia chromosome.
GNH USA supplies Nilotinib Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with a focus on reliable quality and regulatory compliance.
What is Nilotinib used for?
Nilotinib is indicated for diseases driven by the BCR‑ABL tyrosine kinase, primarily chronic myeloid leukemia. - Chronic myeloid leukemia (CML) in chronic phase: reduces leukemic cell proliferation and helps achieve cytogenetic and molecular remission. - Philadelphia chromosome‑positive CML: inhibits BCR‑ABL activity to control disease progression. - Imatinib‑resistant CML: provides an alternative targeted therapy when first‑line TKIs fail. - CML after failure of prior tyrosine kinase inhibitors: offers a later‑line option to maintain disease control.
What are the side effects of Nilotinib?
Nilotinib may cause a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Nausea - Diarrhea - Rash - Headache - Fatigue - Musculoskeletal pain
Serious or Rare Side Effects: - QT interval prolongation - Pancreatitis - Severe hepatic injury - Grade 3‑4 neutropenia - Grade 3‑4 thrombocytopenia - Anaphylactic or severe allergic reactions
What precautions apply to Nilotinib?
When prescribing Nilotinib, clinicians should observe several safety measures to minimize risk. - Cardiac monitoring: perform baseline ECG and monitor QT interval during therapy. - Hematologic monitoring: check complete blood counts regularly for neutropenia or thrombocytopenia. - Hepatic monitoring: assess liver function tests before and during treatment. - Pregnancy avoidance: contraindicated in pregnancy; ensure effective contraception for women of childbearing potential. - Severe hepatic impairment: avoid use in patients with significant liver dysfunction. - Store below 25°C: keep in the original packaging, protect from moisture and light.
What does Nilotinib interact with?
Nilotinib has a notable potential for drug‑drug interactions that require careful management.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase Nilotinib exposure. - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic levels. - Antacids containing aluminum or magnesium: can decrease absorption. - QT‑prolonging agents (e.g., amiodarone, sotalol): increase risk of cardiac arrhythmia. - St. John’s wort: may markedly lower Nilotinib concentrations.
Moderate Interactions (Monitor Closely): - Digoxin: may require serum level monitoring. - Warfarin: monitor INR for potential anticoagulation changes. - Statins (e.g., simvastatin, atorvastatin): adjust dose to avoid toxicity. - H2‑blockers (e.g., ranitidine): may modestly affect absorption. - Proton pump inhibitors (e.g., omeprazole): monitor for reduced bioavailability.
Frequently asked questions
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Product details
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