Europe — EMA
Krufton
GNH USA supplies Krufton (Nilotinib), a tyrosine kinase inhibitor for chronic myeloid leukemia and Philadelphia chromosome‑positive leukemias.
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What is Nilotinib Hydrochloride Dihydrate?
Nilotinib, the active ingredient in Krufton, is a tyrosine kinase inhibitor presented as an oral tablet for systemic use. It is indicated for the treatment of chronic myeloid leukemia in the chronic phase and for Philadelphia chromosome‑positive leukemias. It targets the BCR‑ABL fusion protein that drives malignant cell growth.
GNH USA supplies Krufton as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet global clinical demand.
What is Nilotinib Hydrochloride Dihydrate used for?
Nilotinib is used to treat malignancies driven by the BCR‑ABL tyrosine kinase pathway.
- Chronic myeloid leukemia (CML) in chronic phase: reduces leukemic cell proliferation and achieves hematologic and cytogenetic responses. - Philadelphia chromosome‑positive CML: enables molecular remission and prolongs survival. - Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): contributes to disease control and improves remission rates.
What are the side effects of Nilotinib Hydrochloride Dihydrate?
Nilotinib may cause a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Nausea - Diarrhea - Rash - Fatigue
Serious or Rare Side Effects: - QT interval prolongation, which can lead to arrhythmia - Hepatotoxicity (elevated liver enzymes) - Pancreatitis
What precautions apply to Nilotinib Hydrochloride Dihydrate?
When prescribing nilotinib, clinicians should observe several safety measures.
- Cardiac monitoring: obtain baseline ECG and monitor QT interval regularly. - Hepatic function: assess liver enzymes before treatment and periodically during therapy. - Pregnancy and lactation: contraindicated; drug is classified as pregnancy category D. - Drug interactions: review concomitant medications, especially CYP3A4 modulators. - Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture.
What does Nilotinib Hydrochloride Dihydrate interact with?
Nilotinib interacts with several drug classes; careful review is required.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nilotinib exposure. - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): reduce efficacy. - QT‑prolonging agents (e.g., quinidine, sotalol): risk of arrhythmia. - Antacids containing aluminum or magnesium: impair absorption.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may raise plasma levels. - H2‑blockers or proton pump inhibitors: may affect nilotinib bioavailability. - Diuretics causing hypokalemia: increase QT prolongation risk.
Frequently asked questions
What is Krufton used for?+
How does nilotinib work?+
What determines the usual dose of Krufton?+
Is Krufton safe during pregnancy or breastfeeding?+
How do I order Krufton from GNH USA?+
How does Krufton compare with the main alternative drug or class?+
What are the recommended storage and handling conditions for Krufton?+
How is Krufton administered?+
What are the most serious risks to watch for while on Krufton?+
Who should not use Krufton?+
Product details
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