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

Krufton

Active Ingredient:
Nilotinib Hydrochloride Dihydrate
Origin:
EU

Krufton (Nilotinib Hydrochloride Dihydrate)

Nilotinib Hydrochloride Dihydrate, the active ingredient in Krufton, is a tyrosine kinase inhibitor presented as a tablet for oral use. It selectively inhibits BCR‑ABL kinase activity to treat chronic myeloid leukemia in adult patients.

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 is a targeted therapy that acts on the BCR‑ABL tyrosine‑kinase pathway in chronic myeloid leukemia.

  • Chronic phase CML: improves hematologic and cytogenetic response in Philadelphia chromosome‑positive patients.
  • Accelerated phase CML: helps achieve remission when disease progresses.
  • Imatinib‑resistant CML: provides an alternative oral option for patients who have failed prior tyrosine‑kinase inhibitor therapy.

How It Works

  • Nilotinib binds competitively to the ATP‑binding site of the BCR‑ABL fusion protein, blocking its tyrosine‑kinase activity. This inhibition prevents downstream signaling that drives uncontrolled proliferation of leukemic cells, leading to reduced disease burden and restoration of normal hematopoiesis in chronic myeloid leukemia.

Side Effects

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Rash: skin erythema or pruritus.
  • Fatigue: decreased energy levels.
  • Diarrhea: loose stools, often transient.

Serious or Rare Side Effects

  • QT interval prolongation: may predispose to cardiac arrhythmias.
  • Pancreatitis: abdominal pain with elevated enzymes.
  • Severe liver injury: marked transaminase elevation or hepatitis.
  • Neutropenia: significant reduction in white blood cells.
  • Stevens‑Johnson syndrome: severe skin and mucosal reaction.

Precautions & Warnings

Patients should be monitored for cardiac, hepatic, and hematologic safety.

  • Cardiac monitoring: obtain baseline ECG and repeat periodically to assess QT interval.
  • Hepatic function: check liver enzymes before initiation and during therapy.
  • Electrolyte balance: correct hypokalemia and hypomagnesemia to reduce QT risk.
  • Drug interactions: avoid strong CYP3A4 inhibitors and concomitant QT‑prolonging agents.
  • Pregnancy and lactation: contraindicated unless benefits outweigh potential risks.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture and light.

Avoid Interactions

Nilotinib may interact with several concomitant medicines.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase nilotinib exposure.
  • QT‑prolonging drugs (e.g., amiodarone, sotalol): additive risk of arrhythmia.
  • Antacids containing aluminum or magnesium: reduce nilotinib absorption.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin): may modestly raise levels.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower nilotinib concentrations.
  • Warfarin: monitor INR as nilotinib can affect anticoagulant control.

Frequently Asked Questions

Krufton contains nilotinib, a targeted oral therapy approved for the treatment of Philadelphia chromosome‑positive chronic myeloid leukemia in adult patients, including those in chronic, accelerated, or blast phases and those who have shown resistance to prior tyrosine‑kinase inhibitors.

Nilotinib selectively binds to the ATP‑binding pocket of the BCR‑ABL fusion protein, inhibiting its tyrosine‑kinase activity. This blocks downstream signaling pathways that drive uncontrolled proliferation of leukemic cells, thereby reducing disease activity and allowing normal blood cell production.

The specific dose of Krufton is determined by the prescribing physician based on the patient’s clinical condition, disease phase, and individual tolerance. Dosage adjustments may be required according to response and safety monitoring.

Nilotinib is classified as contraindicated in pregnancy and breastfeeding unless the potential benefit justifies the risk. Women of childbearing potential should use effective contraception, and nursing mothers should discuss alternatives with their healthcare provider.

To place an order, submit an enquiry on the 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 (including any cold‑chain requirements), and necessary import documentation.

Krufton (nilotinib) is a second‑generation tyrosine‑kinase inhibitor offering higher potency against BCR‑ABL than first‑generation agents like imatinib. It is often chosen for patients who need a deeper molecular response or who have developed resistance to earlier therapies, while maintaining an oral dosing schedule.

Krufton tablets should be stored at ambient temperature, below 25 °C, in the original packaging. Protect the product from moisture, direct sunlight, and excessive heat to maintain stability and potency.

Krufton is taken orally, usually with a low‑fat meal to improve absorption. The tablets should be swallowed whole with water and not crushed or chewed. Patients should follow the dosing schedule prescribed by their clinician.

The most serious risks include QT interval prolongation leading to potential cardiac arrhythmias, severe liver injury, pancreatitis, and significant reductions in blood cell counts such as neutropenia or thrombocytopenia. Regular monitoring of cardiac, hepatic, and hematologic parameters is essential.

Krufton should be avoided in patients with a known hypersensitivity to nilotinib or any component of the formulation, those with uncontrolled cardiac arrhythmias or prolonged QT interval, and individuals taking strong CYP3A4 inhibitors or other QT‑prolonging drugs without appropriate medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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