Product image of Krufton (Nilotinib) supplied by GNH India

Krufton

Active Ingredient:
Nilotinib
Origin:
EU

Krufton (Nilotinib)

Nilotinib, the active ingredient in Krufton, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It selectively targets the BCR‑ABL fusion protein, thereby inhibiting the proliferation of Philadelphia chromosome‑positive leukemic cells. The drug is employed in the management of chronic myeloid leukemia, particularly in adult patients who have demonstrated resistance or intolerance to prior therapy.

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

Manufacturer / TM Owner

Egis Pharmaceuticals Plc

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Indications & Clinical Uses

Krufton (nilotinib) is used to treat Philadelphia chromosome‑positive chronic myeloid leukemia across disease phases.

  • Chronic phase CML: reduces disease progression and achieves cytogenetic response.
  • Accelerated phase CML: provides hematologic and cytogenetic improvement when other TKIs are unsuitable.
  • Blast phase CML: offers disease control in patients resistant to prior therapy.

How It Works

  • Nilotinib binds to the ATP‑binding site of the BCR‑ABL tyrosine kinase, stabilizing the inactive conformation of the enzyme. This inhibition blocks downstream signaling pathways that drive proliferation and survival of leukemic cells carrying the Philadelphia chromosome, thereby suppressing malignant growth.

Side Effects

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: watery stools, often transient.
  • Rash: maculopapular skin eruptions.
  • Fatigue: generalized tiredness.
  • Headache: mild to moderate intensity.
  • Myalgia: muscle aches.

Serious or Rare Side Effects

  • QT interval prolongation: may lead to cardiac arrhythmias.
  • Pancreatitis: abdominal pain with elevated enzymes.
  • Hepatotoxicity: elevated liver transaminases.
  • Severe neutropenia: increased infection risk.
  • Stevens‑Johnson syndrome: severe skin and mucosal reactions.
  • Vascular events: arterial occlusive disease.

Precautions & Warnings

Before initiating therapy, patients should be evaluated for cardiac and hepatic health.

  • Cardiac monitoring: baseline ECG and periodic QT assessment.
  • Blood count surveillance: regular CBC to detect neutropenia.
  • Liver function tests: monitor ALT/AST levels.
  • Avoid in known QT‑prolonging conditions: contraindicated in patients with congenital long QT syndrome.
  • Dose adjustment in hepatic impairment: reduce dose if moderate liver dysfunction is present.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Nilotinib may interact with several concomitant medications.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib exposure.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic levels.
  • Antacids containing aluminum or magnesium: can lower absorption if taken simultaneously.

Moderate Interactions (Monitor Closely)

  • Proton pump inhibitors (e.g., omeprazole): may modestly affect bioavailability.
  • Statins metabolized by CYP3A4 (e.g., simvastatin): increased risk of myopathy.
  • Warfarin: potential alteration of INR, requiring closer coagulation monitoring.

Frequently Asked Questions

Krufton contains nilotinib, a targeted therapy indicated for the treatment of Philadelphia chromosome‑positive chronic myeloid leukemia in adults, including chronic, accelerated and blast phases when other tyrosine‑kinase inhibitors are unsuitable.

Nilotinib inhibits the BCR‑ABL tyrosine kinase by binding to its ATP‑binding pocket, locking the enzyme in an inactive state. This blocks downstream signaling that drives the uncontrolled growth of leukemic cells, leading to reduced proliferation and increased apoptosis of the malignant clone.

The prescribed dose of Krufton is determined by the treating physician based on the patient’s disease phase, prior therapy, and individual tolerance. Dosing adjustments may be required for hepatic impairment or drug‑interaction considerations.

Nilotinib is classified as contraindicated in pregnancy because it may cause fetal harm. Women of childbearing potential should use effective contraception. Breastfeeding is not recommended while receiving nilotinib, as the drug can be excreted in milk and affect the infant.

To place an order, submit an enquiry on the Krufton product page at gnhindia.com, specifying 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.

Nilotinib is a second‑generation BCR‑ABL inhibitor offering higher potency and selectivity than first‑generation agents such as imatinib. It provides faster and deeper molecular responses, especially in patients resistant or intolerant to earlier TKIs, though safety monitoring for cardiac and metabolic effects is essential.

Krufton should be stored at temperatures below 25 °C, protected from moisture and light. Keep the product in its original container until use, and avoid exposing it to high humidity or direct sunlight to maintain potency.

Krufton is taken orally, usually twice daily on an empty stomach (at least one hour before or two hours after a meal). Tablets should be swallowed whole with a glass of water; they must not be chewed, crushed, or split unless specifically instructed by a healthcare professional.

The most serious adverse events include QT interval prolongation leading to potentially fatal arrhythmias, severe hepatotoxicity, pancreatitis, and rare but life‑threatening skin reactions such as Stevens‑Johnson syndrome. Patients should be monitored regularly for cardiac, hepatic and pancreatic function.

Krufton is contraindicated in patients with a known history of QT prolongation, uncontrolled cardiac disease, or severe hepatic impairment. It should also be avoided in individuals taking strong CYP3A4 inducers or inhibitors that cannot be safely managed, and in pregnant or breastfeeding women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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