Product image of Krufton (Nilotinib Hydrochloride Dihydrate) supplied by GNH India

Krufton

Active Ingredient:
Nilotinib Hydrochloride Dihydrate
Origin:
EU

Krufton (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 India supplies Krufton as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Egis Pharmaceuticals Plc

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Indications & Clinical Uses

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.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase by binding to its ATP‑binding site, blocking downstream signaling that drives malignant cell proliferation. It also inhibits the related kinases KIT and PDGFR, contributing to its antineoplastic activity. By preventing phosphorylation events essential for leukemic cell survival, nilotinib reduces the growth of Philadelphia chromosome‑positive leukemic clones.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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

Krufton contains nilotinib, which is prescribed to treat Philadelphia chromosome‑positive chronic myeloid leukemia (CML). It is used in adult patients either as a first‑line option or after resistance or intolerance to other BCR‑ABL inhibitors.

Nilotinib blocks the BCR‑ABL tyrosine kinase by binding to its ATP‑binding pocket, halting the signaling cascade that drives uncontrolled growth of leukemic cells. It also inhibits KIT and PDGFR kinases, adding to its antileukemic effect.

The dosage of Krufton is individualized by the prescribing clinician based on the patient’s disease stage, prior therapy, and overall health. Only a qualified healthcare professional should determine the appropriate regimen.

Safety of nilotinib in pregnancy or while nursing has not been established. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and a prescriber should discuss alternatives.

To request Krufton, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Krufton (nilotinib) is a second‑generation BCR‑ABL inhibitor, offering higher potency and a different safety profile compared with first‑generation agents such as imatinib. It may achieve faster molecular responses but requires careful monitoring for cardiac and metabolic effects.

Krufton tablets should be stored at temperatures below 25 °C, in the original container, protected from moisture and light. Keep the product out of reach of children and do not use if the packaging is damaged.

Krufton is taken orally, usually once daily on an empty stomach (at least two hours after a meal and one hour before the next meal). Swallow the tablet whole with a glass of water; do not crush or chew it.

The most critical adverse events include QT interval prolongation, which can lead to serious arrhythmias, pancreatitis, and severe liver injury. Patients should be monitored regularly with ECGs, pancreatic enzymes and liver function tests.

Krufton is contraindicated in patients with a known history of prolonged QT interval, uncontrolled cardiac disease, or severe hepatic impairment. It should also be avoided in individuals taking strong CYP3A4 inhibitors or other QT‑prolonging medications without careful supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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