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 tablet for oral administration. It selectively blocks the BCR‑ABL fusion protein, thereby inhibiting the uncontrolled proliferation of leukemic cells. The medication is used primarily in adult patients diagnosed with chronic myeloid leukemia. It is marketed in the European Union and meets stringent regulatory standards.

GNH India supplies Krufton as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide, providing reliable access to quality‑assured medicines for cancer care through a robust distribution network that ensures timely delivery.

Manufacturer / TM Owner

Egis Pharmaceuticals Plc

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Indications & Clinical Uses

Krufton (nilotinib) targets the BCR‑ABL driven pathway in chronic myeloid leukemia, providing disease control in patients who require a second‑generation tyrosine kinase inhibitor.

  • Chronic myeloid leukemia (CML): reduces disease progression and improves survival in adult patients.

How It Works

  • Nilotinib binds to the ATP‑binding site of the BCR‑ABL fusion protein, stabilizing it in an inactive conformation. This inhibition blocks downstream signaling cascades that drive proliferation and survival of leukemic cells, leading to cell cycle arrest and apoptosis in BCR‑ABL‑positive malignancies.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: loose stools often occurring early in therapy.
  • Rash: skin eruptions ranging from macular to papular.
  • Headache: transient mild to moderate pain.
  • Fatigue: general tiredness without specific cause.
  • Elevated liver enzymes: mild increases in transaminases.

Serious or Rare Side Effects

  • QT interval prolongation: risk of ventricular arrhythmias.
  • Arterial occlusive events: including peripheral arterial disease.
  • Pancreatitis: inflammation of the pancreas with abdominal pain.
  • Severe hepatic injury: marked elevation of liver enzymes or bilirubin.
  • Severe neutropenia: marked reduction in neutrophil count.
  • Severe thrombocytopenia: low platelet counts leading to bleeding risk.

Precautions & Warnings

Patients should be monitored for specific safety concerns before and during treatment.

  • Cardiovascular monitoring: obtain baseline ECG and repeat periodically to assess QT interval.
  • Liver function: check transaminases and bilirubin at regular intervals.
  • Pancreatic enzymes: monitor amylase and lipase for signs of pancreatitis.
  • Hematologic parameters: perform complete blood counts to detect cytopenias.
  • Drug interactions: avoid concomitant use of strong CYP3A4 inhibitors.
  • Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture.

Avoid Interactions

Nilotinib may interact with other medicines, altering its effectiveness or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib exposure and toxicity.
  • QT‑prolonging agents (e.g., amiodarone, sotalol): heighten risk of arrhythmias.
  • Antacids containing aluminum or magnesium: reduce nilotinib absorption.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower nilotinib plasma levels.
  • Warfarin: may require more frequent INR monitoring.
  • St. John’s wort: can decrease nilotinib concentrations.

Frequently Asked Questions

Krufton contains nilotinib, a second‑generation tyrosine kinase inhibitor that is approved for the treatment of chronic myeloid leukemia (CML) in adult patients. It works by targeting the BCR‑ABL protein that drives the growth of leukemic cells, helping to control disease progression.

Nilotinib binds to the ATP‑binding pocket of the BCR‑ABL fusion protein, locking it in an inactive state. This blocks downstream signaling pathways that promote cell proliferation and survival, leading to reduced growth of leukemic cells and, ultimately, their death.

The dosage of Krufton is individualized by the prescribing physician based on the patient’s clinical condition, response, and tolerance. The prescriber determines the appropriate strength, frequency, and duration of therapy according to current medical guidelines.

Safety data for nilotinib in pregnancy and lactation are limited. It is generally advised to avoid use during pregnancy unless the potential benefit justifies the risk, and breastfeeding is not recommended while on therapy because the drug may be excreted in milk.

To request Krufton, 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 and any necessary import documentation.

Compared with first‑generation inhibitors such as imatinib, nilotinib (Krufton) offers higher potency against BCR‑ABL and can be effective in patients who have resistance or intolerance to imatinib. However, it may have a different safety profile, including a higher risk of cardiovascular events, requiring careful monitoring.

Krufton tablets should be stored at ambient temperature, below 25 °C, in the original blister pack or container. Protect them from moisture and direct sunlight. Do not refrigerate or freeze the product, and keep it out of reach of children.

Krufton is taken orally, usually as a tablet, with a moderate‑fat meal to improve absorption. Patients should swallow the tablet whole with water and follow the dosing schedule prescribed by their healthcare provider, without crushing or chewing the tablet.

The most serious risks include QT interval prolongation leading to potentially fatal arrhythmias, arterial occlusive events such as peripheral vascular disease, severe pancreatitis, and significant hepatic injury. Prompt medical attention is required if symptoms such as chest pain, shortness of breath, severe abdominal pain, or jaundice occur.

Krufton should be avoided in patients with a known hypersensitivity to nilotinib or any component of the formulation, in those with a history of prolonged QT interval, uncontrolled cardiovascular disease, or severe hepatic impairment. It is also contraindicated in patients taking strong CYP3A4 inhibitors without appropriate dose adjustment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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