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 systemic use. It is indicated for the treatment of chronic myeloid leukemia in the chronic phase and for Philadelphia chromosome‑positive leukemias. It targets the BCR‑ABL fusion protein that drives malignant cell growth.

GNH India supplies Krufton as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet global clinical demand.

Manufacturer / TM Owner

Egis Pharmaceuticals Plc

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Indications & Clinical Uses

Nilotinib is used to treat malignancies driven by the BCR‑ABL tyrosine kinase pathway.

  • Chronic myeloid leukemia (CML) in chronic phase: reduces leukemic cell proliferation and achieves hematologic and cytogenetic responses.
  • Philadelphia chromosome‑positive CML: enables molecular remission and prolongs survival.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): contributes to disease control and improves remission rates.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase by binding to its ATP‑binding site, preventing phosphorylation of downstream substrates. This blockade halts the signaling cascade that promotes uncontrolled proliferation, survival and migration of malignant hematopoietic cells. By targeting the constitutively active fusion protein, nilotinib restores normal cellular regulation and induces apoptosis in leukemic clones.

Side Effects

Nilotinib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea
  • Diarrhea
  • Rash
  • Fatigue

Serious or Rare Side Effects

  • QT interval prolongation, which can lead to arrhythmia
  • Hepatotoxicity (elevated liver enzymes)
  • Pancreatitis

Precautions & Warnings

When prescribing nilotinib, clinicians should observe several safety measures.

  • Cardiac monitoring: obtain baseline ECG and monitor QT interval regularly.
  • Hepatic function: assess liver enzymes before treatment and periodically during therapy.
  • Pregnancy and lactation: contraindicated; drug is classified as pregnancy category D.
  • Drug interactions: review concomitant medications, especially CYP3A4 modulators.
  • Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture.

Avoid Interactions

Nilotinib interacts with several drug classes; careful review is required.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nilotinib exposure.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): reduce efficacy.
  • QT‑prolonging agents (e.g., quinidine, sotalol): risk of arrhythmia.
  • Antacids containing aluminum or magnesium: impair absorption.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may raise plasma levels.
  • H2‑blockers or proton pump inhibitors: may affect nilotinib bioavailability.
  • Diuretics causing hypokalemia: increase QT prolongation risk.

Frequently Asked Questions

Krufton contains nilotinib, a targeted therapy indicated for chronic myeloid leukemia in the chronic phase and for Philadelphia chromosome‑positive leukemias, including both CML and acute lymphoblastic leukemia. It is prescribed to patients whose disease is driven by the BCR‑ABL fusion protein.

Nilotinib blocks the BCR‑ABL tyrosine kinase by occupying its ATP‑binding pocket, which stops downstream signaling that promotes uncontrolled growth of malignant blood cells. This inhibition restores normal cellular regulation and leads to apoptosis of the leukemic clone.

The dose of Krufton is individualized by the treating physician based on the patient’s disease status, prior therapy, renal and hepatic function, and potential drug interactions. Only a qualified prescriber should set the dosing regimen.

Nilotinib is classified as pregnancy category D, indicating evidence of risk to the fetus. It is contraindicated in pregnancy and not recommended while breastfeeding because it can be excreted in milk and may harm the infant.

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.

Krufton (nilotinib) is a second‑generation BCR‑ABL inhibitor, offering higher potency and activity against many imatinib‑resistant mutations. Compared with first‑generation agents, it often achieves faster and deeper molecular responses, but it also carries a distinct safety profile that requires cardiac and metabolic monitoring.

Krufton tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack to protect from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Krufton is taken orally, usually as a whole tablet swallowed with a moderate‑fat meal to improve absorption. Patients should follow the prescriber’s instructions regarding timing, food intake, and any required dose adjustments.

The most critical adverse events include QT interval prolongation, which can lead to life‑threatening arrhythmias, severe liver toxicity, and pancreatitis. Regular ECG monitoring, liver function tests, and prompt reporting of symptoms such as chest pain, jaundice or severe abdominal pain are essential.

Krufton is contraindicated in patients with a known hypersensitivity to nilotinib or any component of the formulation, in pregnant or nursing women, and in individuals with a history of significant QT prolongation or uncontrolled cardiac disease unless the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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