Europe — EMA
Nilotinib Zentiva
GNH USA supplies Nilotinib Zentiva (Nilotinib), a tyrosine kinase inhibitor for chronic myeloid leukemia and Philadelphia chromosome‑positive acute
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What is Nilotinib?
Nilotinib, the active ingredient in Nilotinib Zentiva, is a tyrosine kinase inhibitor presented as a tablet for oral use. It selectively targets BCR‑ABL positive cells and is used to treat chronic myeloid leukemia and Philadelphia chromosome‑positive acute lymphoblastic leukemia in adult patients. The medication is approved in the European Union for these indications.
GNH USA supplies Nilotinib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.
What is Nilotinib used for?
Nilotinib is indicated for hematologic malignancies driven by the BCR‑ABL tyrosine kinase.
- Chronic myeloid leukemia: reduces disease progression and improves survival in patients with BCR‑ABL positive disease. - Philadelphia chromosome‑positive acute lymphoblastic leukemia: contributes to remission induction and maintenance in adult patients.
What are the side effects of Nilotinib?
Nilotinib may be associated with a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Rash: mild to moderate skin eruptions. - Nausea: occasional gastrointestinal discomfort. - Diarrhea: loose stools, often transient. - Elevated serum lipase or amylase: mild enzyme increase without pancreatitis.
Serious or Rare Side Effects: - Cardiovascular events: myocardial infarction, stroke, or peripheral arterial disease. - Hepatotoxicity: significant elevation of liver enzymes or hepatitis. - Pancreatitis: acute inflammation of the pancreas, potentially severe.
What precautions apply to Nilotinib?
When prescribing Nilotinib, clinicians should consider several safety measures and monitoring requirements.
- Cardiac monitoring: assess baseline ECG and monitor for ischemic events. - Liver function: check transaminases before initiation and periodically. - Lipid profile: monitor cholesterol and triglycerides during therapy. - Glucose control: observe blood glucose in diabetic patients. - Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors. - Store at ambient temperature: keep below 25 °C, retain in original container, protect from moisture and light.
What does Nilotinib interact with?
Nilotinib interacts with several medicines that affect its metabolism or increase toxicity risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise Nilotinib plasma levels and toxicity. - Antacids containing aluminum or magnesium: reduce absorption of Nilotinib.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole, diltiazem): may require dose adjustment. - CYP3A4 inducers (e.g., rifampin, carbamazepine): can lower Nilotinib exposure, reducing efficacy. - Proton pump inhibitors: may decrease bioavailability; consider timing separation.
Frequently asked questions
What is Nilotinib Zentiva used for?+
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Product details
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