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 is indicated for the treatment of chronic myeloid 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.

Manufacturer / TM Owner

Zentiva France

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Indications & Clinical Uses

Nilotinib is a targeted therapy used within the chronic myeloid leukemia treatment pathway.

  • Chronic Myeloid Leukemia (CML): improves hematologic and cytogenetic response and reduces disease progression.
  • Accelerated‑phase CML: helps achieve hematologic remission and stabilises disease.
  • Blast‑phase CML: provides disease control when other options are limited.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, as well as related kinases such as c‑KIT and PDGFR. By blocking these enzymes, it disrupts downstream signaling pathways that drive uncontrolled proliferation of malignant leukemic cells, leading to reduced tumor growth and increased apoptosis.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Diarrhea: loose stools occurring intermittently.
  • Rash: skin irritation or erythema.
  • Fatigue: feeling unusually tired or weak.

Serious or Rare Side Effects

  • QT prolongation: potential cardiac rhythm disturbance requiring ECG monitoring.
  • Pancreatitis: inflammation of the pancreas presenting with abdominal pain.
  • Severe liver injury: marked elevation of liver enzymes or hepatitis.

Precautions & Warnings

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

  • Cardiac monitoring: obtain baseline ECG and repeat periodically due to QT‑interval risk.
  • Liver function: assess hepatic enzymes prior to initiation and regularly thereafter.
  • Hematologic surveillance: perform complete blood counts to detect neutropenia or thrombocytopenia.
  • Concomitant CYP3A4 inhibitors: avoid strong inhibitors that may increase nilotinib exposure.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): can raise plasma levels.
  • QT‑prolonging agents (e.g., quinidine, sotalol): increase risk of cardiac arrhythmia.
  • Antacids containing aluminum or magnesium: reduce nilotinib absorption.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin): may modestly increase exposure.
  • St. John’s wort: enzyme induction can lower drug concentrations.
  • Warfarin: potential alteration of anticoagulant effect, requiring INR monitoring.

Frequently Asked Questions

Nilotinib Zentiva is prescribed for the treatment of chronic myeloid leukemia (CML), including its accelerated and blast phases, in adult patients. It targets the BCR‑ABL fusion protein that drives the disease, helping to control disease progression and improve blood counts.

Nilotinib works by selectively inhibiting the BCR‑ABL tyrosine kinase as well as related kinases such as c‑KIT and PDGFR. This blockade interferes with signaling pathways that promote uncontrolled cell division, leading to reduced proliferation of leukemic cells and increased programmed cell death.

The specific dose of Nilotinib Zentiva is determined by the prescribing clinician based on the patient’s disease phase, prior therapy, and individual health factors. Healthcare professionals adjust the regimen according to approved guidelines and patient response.

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. Physicians should discuss alternatives and risk mitigation with patients.

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.

Nilotinib belongs to the second‑generation tyrosine kinase inhibitor class and offers higher potency against BCR‑ABL compared with first‑generation agents like imatinib. It may achieve faster and deeper molecular responses, but its safety profile includes a higher risk of QT prolongation, requiring cardiac monitoring.

Nilotinib tablets should be stored at room temperature, 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.

The medication is taken orally, usually once daily on an empty stomach (at least one hour before or two hours after a meal). Patients should swallow the tablet whole with water and follow the dosing schedule prescribed by their healthcare provider.

The most serious risks include QT‑interval prolongation, which can lead to life‑threatening arrhythmias, severe liver injury, pancreatitis, and marked reductions in blood cell counts (neutropenia, thrombocytopenia). Prompt reporting of symptoms such as palpitations, jaundice, severe abdominal pain, or unusual bleeding is essential.

Patients with a known hypersensitivity to nilotinib or any of its excipients should avoid the drug. Those with uncontrolled cardiac disease, significant QT prolongation, severe hepatic impairment, or who are taking contraindicated strong CYP3A4 inhibitors should not be treated with nilotinib without specialist evaluation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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