Europe — EMA
Krufton
GNH USA supplies Krufton (Nilotinib), a tyrosine kinase inhibitor for Philadelphia chromosome‑positive chronic myeloid leukemia.
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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 oral use. It is indicated for the treatment of Philadelphia chromosome‑positive chronic myeloid leukemia in adult patients.
GNH USA supplies Krufton as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nilotinib Hydrochloride Dihydrate used for?
Nilotinib is used to target the BCR‑ABL driven pathway in chronic myeloid leukemia.
- Chronic phase CML: improves molecular and cytogenetic response, slowing disease progression. - Philadelphia chromosome‑positive CML after imatinib resistance: provides an effective alternative therapy. - Newly diagnosed Philadelphia chromosome‑positive CML: offers first‑line treatment option.
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: mild to moderate upset stomach. - Diarrhea: loose stools. - Rash: skin irritation or redness. - Fatigue: decreased energy levels.
Serious or Rare Side Effects: - QT interval prolongation: may lead to cardiac arrhythmias. - Pancreatitis: inflammation of the pancreas. - Severe liver injury: marked elevation of hepatic enzymes or hepatitis.
What precautions apply to Nilotinib Hydrochloride Dihydrate?
When prescribing nilotinib, clinicians should observe several precautionary measures to ensure patient safety.
- Cardiac monitoring: assess baseline ECG and monitor QT interval during therapy. - Blood glucose monitoring: watch for hyperglycemia, especially in diabetic patients. - Liver function tests: evaluate hepatic enzymes before and periodically during treatment. - Concomitant QT‑prolonging drugs: avoid or use with caution due to additive risk. - Dose adjustment in hepatic impairment: consider reduced dosing in moderate liver dysfunction. - Store at below 25°C: keep in the original packaging, protect from moisture and light.
What does Nilotinib Hydrochloride Dihydrate interact with?
Nilotinib interacts with several medicines; awareness of these interactions helps prevent altered drug exposure.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors: may markedly increase nilotinib plasma levels. - QT‑prolonging agents: additive risk of serious cardiac arrhythmias. - Acid‑reducing agents (antacids, H2 blockers, PPIs): can reduce nilotinib absorption.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers: may lower nilotinib concentrations, reducing efficacy. - Warfarin: nilotinib may affect INR, requiring closer coagulation monitoring. - Certain statins (simvastatin, lovastatin): increased risk of statin‑related toxicity.
Frequently asked questions
What is Krufton used for?+
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What is the usual dose of Krufton?+
Is Krufton safe during pregnancy or breastfeeding?+
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Product details
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