Product image of Nilotinib Zentiva (Nilotinib) supplied by GNH India

Nilotinib Zentiva

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib Zentiva (Nilotinib)

Nilotinib, the active ingredient in Nilotinib Zentiva, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It selectively blocks BCR‑ABL, c‑KIT and PDGFR signaling and is indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome‑positive acute lymphoblastic leukemia in adult patients.

GNH India supplies Nilotinib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance through reliable logistics and support.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Nilotinib is a targeted therapy used in the management of BCR‑ABL‑positive leukemias.

  • Chronic Myeloid Leukemia (CML): provides disease control across chronic, accelerated, and blast phases.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): enables remission induction and maintenance in adult patients.
  • Imatinib‑resistant CML: offers an alternative targeted option after prior tyrosine kinase inhibitor therapy.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase as well as the related c‑KIT and platelet‑derived growth factor receptors (PDGFR). By binding to the ATP‑binding site of these kinases, it blocks downstream signaling pathways that drive proliferation and survival of malignant hematopoietic cells, leading to reduced tumor growth and increased apoptosis.

Side Effects

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

Common Side Effects

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

Serious or Rare Side Effects

  • QT interval prolongation: may lead to cardiac arrhythmia.
  • Pancreatitis: abdominal pain with elevated enzymes.
  • Severe hepatotoxicity: marked liver enzyme elevation or hepatitis.

Precautions & Warnings

When prescribing Nilotinib, clinicians should observe several safety considerations.

  • Cardiac monitoring: assess QT interval and correct electrolyte abnormalities.
  • Hepatic function: monitor liver enzymes regularly.
  • Pancreatic enzymes: check amylase and lipase during therapy.
  • Concomitant QT‑prolonging drugs: avoid or use with caution.
  • Renal impairment: adjust dose or monitor renal function as needed.
  • Store at ambient temperature: keep in the original container, protect from moisture.

Avoid Interactions

Nilotinib is metabolized primarily by CYP3A4, leading to potential drug‑drug interactions.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nilotinib exposure.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
  • Antacids containing aluminum or magnesium: can impair absorption.
  • QT‑prolonging agents (e.g., amiodarone, sotalol): increase risk of arrhythmia.
  • St. John's wort: may lower plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Digoxin: may require serum level monitoring.
  • Warfarin: monitor INR for potential anticoagulation changes.

Frequently Asked Questions

Nilotinib Zentiva is indicated for adult patients with chronic myeloid leukemia (CML) in any phase and for Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL). It is also used when disease has progressed after prior tyrosine kinase inhibitor therapy.

Nilotinib selectively blocks the BCR‑ABL, c‑KIT and PDGFR tyrosine kinases by binding to their ATP‑binding sites. This inhibition stops downstream signaling that drives malignant cell growth, leading to reduced proliferation and increased programmed cell death of leukemic cells.

The specific dose and dosing schedule of Nilotinib Zentiva are determined by the prescribing physician based on the patient’s disease stage, prior therapy, and individual health factors. Patients should follow the exact regimen provided by their healthcare professional.

Nilotinib is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should not be used during pregnancy unless the potential benefit justifies the risk. Breastfeeding is not recommended while on treatment, as the drug can be excreted in milk.

To place an order, 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.

Nilotinib is a second‑generation BCR‑ABL inhibitor that offers higher potency and selectivity compared with first‑generation agents such as imatinib. It is often chosen for patients who have resistance or intolerance to earlier drugs, though safety profiles and drug‑interaction potentials differ and should be evaluated individually.

Nilotinib Zentiva tablets should be stored at ambient temperature, below 25 °C, in the original packaging to protect them from moisture and light. Do not store in areas with high humidity or extreme heat.

The medication is taken orally, usually with a low‑fat meal to improve absorption. Patients should swallow the tablet whole with water and follow the timing and dietary instructions given by their prescriber.

The most serious adverse events include QT interval prolongation, which can lead to life‑threatening arrhythmias, severe liver toxicity, and pancreatitis. Regular cardiac monitoring, liver function tests, and pancreatic enzyme assessments are essential to detect these risks early.

Patients with a known hypersensitivity to nilotinib or any of its excipients should avoid the drug. It is also contraindicated in individuals with a history of significant QT prolongation, uncontrolled cardiac disease, or severe hepatic impairment unless specifically advised by a specialist.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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