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 a tablet for oral use. It treats 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 and pharmacies worldwide.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Nilotinib is indicated for hematologic malignancies driven by the BCR‑ABL fusion protein.

  • Chronic myeloid leukemia (CML): reduces disease progression and improves survival in chronic, accelerated, and blast phases.
  • Chronic myeloid leukemia (CML) after prior TKI therapy: provides an alternative option for patients who have failed or cannot tolerate other tyrosine kinase inhibitors.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): contributes to remission when used in combination with chemotherapy.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, as well as the related c‑KIT and PDGFR kinases. By blocking these signaling pathways, it prevents uncontrolled proliferation of malignant cells and induces apoptosis, thereby controlling the growth of leukemic clones that depend on BCR‑ABL activity.

Side Effects

Common Side Effects

  • Nausea
  • Diarrhea
  • Rash
  • Fatigue

Serious or Rare Side Effects

  • QT interval prolongation
  • Pancreatitis
  • Severe liver enzyme elevation

Precautions & Warnings

Nilotinib requires careful monitoring and patient counseling before and during therapy.

  • ECG monitoring: obtain baseline and periodic ECGs to detect QT prolongation.
  • Liver function tests: assess hepatic enzymes before initiation and regularly during treatment.
  • Blood glucose monitoring: watch for hyperglycemia, especially in diabetic patients.
  • Pregnancy avoidance: drug is contraindicated in pregnancy (Category D); use effective contraception.
  • Store at ambient temperature: keep below 25°C in the original pack, protect from moisture.

Avoid Interactions

Nilotinib may interact with several concomitant medicines, requiring dose adjustments or avoidance.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nilotinib exposure.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): reduce nilotinib effectiveness.
  • Proton pump inhibitors and antacids that raise gastric pH: may lower nilotinib absorption.
  • Other QT‑prolonging agents (e.g., macrolide antibiotics, antiarrhythmics): increase risk of cardiac arrhythmia.

Moderate Interactions (Monitor Closely)

  • Warfarin: nilotinib can alter INR; monitor coagulation parameters.
  • Statins metabolized by CYP3A4 (e.g., simvastatin): may increase statin levels; consider dose reduction.
  • Digoxin: potential increase in serum digoxin; monitor levels and clinical response.

Frequently Asked Questions

Nilotinib Zentiva is prescribed for adult patients with chronic myeloid leukemia (CML) in any disease phase and for Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL). It targets the BCR‑ABL fusion protein that drives these leukemias, helping to control disease progression and improve survival.

Nilotinib blocks the activity of the BCR‑ABL tyrosine kinase as well as related kinases c‑KIT and PDGFR. By inhibiting these enzymes, it disrupts signaling pathways that promote uncontrolled cell division, leading to reduced proliferation of leukemic cells and induction of programmed cell death.

The specific dose of Nilotinib Zentiva is determined by the prescribing physician based on the patient’s disease phase, prior treatments, and individual health factors. Only a qualified healthcare professional can set the appropriate dosing regimen.

Nilotinib is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should not be used during pregnancy, and effective contraception is required. Breastfeeding is not recommended while on treatment because the drug may be excreted in milk.

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 and any necessary import documentation.

Nilotinib is a second‑generation BCR‑ABL inhibitor with higher potency against many resistant BCR‑ABL mutations compared with first‑generation agents like imatinib. It also has activity against c‑KIT and PDGFR, but its safety profile includes a higher risk of QT prolongation, requiring cardiac monitoring.

Store Nilotinib Zentiva tablets at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Do not refrigerate or freeze the tablets, and keep them out of reach of children.

Nilotinib Zentiva is taken orally, usually as whole tablets with a low‑fat meal. The tablets should be swallowed with water and not crushed or chewed. Patients should follow the dosing schedule and dietary instructions provided by their prescriber.

The most serious risks include QT interval prolongation, which can lead to life‑threatening arrhythmias, severe liver injury, and pancreatitis. Patients should undergo regular ECG monitoring, liver function tests, and be educated on symptoms that require immediate medical attention.

Nilotinib should not be used by patients with a known hypersensitivity to nilotinib or any of its excipients, those with a history of prolonged QT interval, uncontrolled cardiac disease, or severe hepatic impairment. Pregnant women and breastfeeding mothers should also avoid the medication.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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