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

Nilotinib Stada

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib Stada (Nilotinib)

Nilotinib, the active ingredient in Nilotinib Stada, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats chronic myeloid leukemia in the chronic phase and Philadelphia chromosome‑positive acute lymphoblastic leukemia in adult patients. The drug works by targeting the BCR‑ABL protein that drives malignant cell growth.

GNH India supplies Nilotinib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Laboratorio Stada, S.L.

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Nilotinib is a targeted oral therapy that inhibits the BCR‑ABL tyrosine‑kinase pathway in specific leukemias.

  • Chronic myeloid leukemia (CML) in chronic phase: helps achieve and maintain cytogenetic and molecular remission.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): used in combination with chemotherapy to improve survival outcomes.

How It Works

  • Nilotinib selectively binds to the ATP‑binding site of the BCR‑ABL fusion protein, preventing its phosphorylation activity. By blocking downstream signaling cascades, the drug halts proliferation and induces apoptosis of leukemic cells that depend on BCR‑ABL driven pathways, while sparing most normal cells.

Side Effects

Nilotinib may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

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

Serious or Rare Side Effects

  • QT interval prolongation: risk of cardiac arrhythmia.
  • Elevated pancreatic enzymes: may indicate pancreatitis.
  • Severe hepatotoxicity: marked increase in liver transaminases.

Precautions & Warnings

Patients receiving Nilotinib should be monitored for specific safety concerns.

  • Cardiac monitoring: assess QT interval before and during therapy.
  • Hepatic function: check liver enzymes regularly.
  • Metabolic control: monitor blood glucose and lipid levels.
  • Drug interactions: avoid strong CYP3A4 inhibitors and QT‑prolonging agents.
  • Pregnancy and lactation: use only if benefits outweigh potential risks.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Nilotinib interacts with several medicines that can alter its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib exposure.
  • QT‑prolonging drugs (e.g., amiodarone, fluoroquinolones): raise risk of cardiac arrhythmia.
  • Antacids or proton‑pump inhibitors that raise gastric pH: reduce nilotinib absorption.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin): may require dose adjustment.
  • Warfarin: monitor INR as nilotinib can affect anticoagulation control.

Frequently Asked Questions

Nilotinib Stada is indicated for the treatment of chronic myeloid leukemia in the chronic phase and for Philadelphia chromosome‑positive acute lymphoblastic leukemia. In both diseases, the drug targets the BCR‑ABL protein that drives malignant cell growth, helping to achieve remission and improve survival when used as prescribed.

Nilotinib binds selectively to the ATP‑binding pocket of the BCR‑ABL tyrosine‑kinase fusion protein. This blocks the enzyme’s activity, halting downstream signaling pathways that promote uncontrolled cell division. By inhibiting BCR‑ABL, nilotinib induces apoptosis in leukemic cells while sparing most normal tissues.

The specific dose of Nilotinib Stada is determined by the prescribing clinician based on the patient’s disease status, body weight, renal and hepatic function, and other individual factors. Healthcare professionals follow approved prescribing information and adjust the regimen as needed for safety and efficacy.

The safety of nilotinib in pregnancy and lactation has not been established. It is classified as pregnancy category unknown, and the drug may pose risks to the fetus or infant. Use only if the potential benefit justifies the potential risk, and discuss alternatives with a healthcare provider.

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 is a second‑generation BCR‑ABL inhibitor that offers higher potency against many resistant BCR‑ABL mutations compared with first‑generation agents like imatinib. It has a distinct safety profile, including a higher risk of QT prolongation, and may be chosen when patients require a more potent option or have specific mutation patterns.

Nilotinib Stada tablets should be stored at room temperature, below 25 °C, in the original blister pack or container. Protect the product from moisture, excessive heat and direct sunlight to maintain stability throughout its shelf life.

Nilotinib Stada is taken orally, usually as whole tablets with a low‑fat meal. Patients should swallow the tablets whole with water and follow the dosing schedule prescribed by their clinician, ensuring consistent timing and food conditions to optimize absorption.

The most serious risks include QT interval prolongation, which can lead to potentially fatal arrhythmias, severe liver toxicity, and pancreatitis. Patients should undergo regular cardiac monitoring, liver function tests, and pancreatic enzyme assessments, and report any symptoms such as palpitations, jaundice or severe abdominal pain promptly.

Nilotinib Stada is contraindicated in patients with a known hypersensitivity to nilotinib or any of its excipients, and in individuals taking strong CYP3A4 inhibitors or drugs that significantly prolong the QT interval. It should also be avoided in patients with uncontrolled cardiac arrhythmias or severe hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.