Product image of Nilotinib supplied by GNH India

Nilotinib

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib

Nilotinib, the active ingredient in Nilotinib, 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 patients whose disease is driven by the BCR‑ABL fusion protein.

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

Manufacturer / TM Owner

Viatris Limited

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 used in BCR‑ABL driven leukemias.

  • Chronic myeloid leukemia (CML) in chronic phase: reduces malignant cell proliferation and improves long‑term survival.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): provides disease‑specific inhibition of BCR‑ABL signaling.
  • Other BCR‑ABL positive leukemias: offers a targeted option where the fusion protein is present.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, a constitutively active enzyme that drives uncontrolled cell growth in certain leukemias. By binding to the ATP‑binding site, it blocks downstream signaling pathways, also affecting PDGFR and c‑KIT receptors, which leads to reduced proliferation and increased apoptosis of malignant cells.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: loose stools that may require fluid replacement.
  • Rash: skin erythema or pruritus.
  • Elevated liver enzymes: mild transaminase increases.
  • Fatigue: generalized tiredness.

Serious or Rare Side Effects

  • Cardiovascular events: including arterial occlusion or ischemia.
  • Pancreatitis: severe abdominal pain with elevated enzymes.
  • Severe hepatic injury: marked elevation of bilirubin or transaminases.
  • QT interval prolongation: risk of cardiac arrhythmias.

Precautions & Warnings

Nilotinib requires careful monitoring and patient counseling.

  • Cardiac assessment: evaluate baseline ECG and monitor QT interval.
  • Hepatic function: check liver enzymes before and during therapy.
  • Pancreatic enzymes: monitor amylase and lipase periodically.
  • Drug interactions: avoid concomitant strong CYP3A4 inhibitors.
  • Pregnancy and lactation: use only if benefits outweigh potential risks; discuss with a specialist.
  • Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Nilotinib may interact with several drug classes, altering its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): can markedly increase nilotinib plasma levels.
  • Proton pump inhibitors: may reduce absorption and lower effectiveness.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): may decrease nilotinib exposure.
  • Antacids containing aluminum or magnesium: can affect gastric pH and drug absorption.
  • Anticoagulants (e.g., warfarin): may require INR monitoring due to potential pharmacodynamic changes.

Frequently Asked Questions

Nilotinib is indicated for the treatment of chronic myeloid leukemia in the chronic phase and for Philadelphia chromosome‑positive acute lymphoblastic leukemia. It targets the BCR‑ABL fusion protein that drives these malignancies, providing a disease‑specific therapeutic approach.

Nilotinib binds selectively to the ATP‑binding pocket of the BCR‑ABL tyrosine kinase, inhibiting its activity. This blocks downstream signaling that promotes cell proliferation and survival, while also affecting related kinases such as PDGFR and c‑KIT, leading to reduced growth of malignant cells.

The dose of Nilotinib is individualized by the prescribing physician based on the patient’s clinical status, disease phase, and tolerability. Dosing regimens are determined by the treating oncologist and should follow the approved prescribing information.

The safety of Nilotinib in pregnancy and lactation has not been established. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and this decision must be made in consultation with a specialist.

To request Nilotinib, 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. Its distinct binding profile may offer efficacy in patients who have progressed on earlier TKIs, though safety and tolerability profiles differ.

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

Nilotinib 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 healthcare provider, adhering to any food‑related instructions.

Serious risks include cardiovascular events such as arterial occlusion, QT‑interval prolongation that can lead to arrhythmias, severe hepatic injury, and pancreatitis. Patients should be monitored regularly for these conditions, and any concerning symptoms should prompt immediate medical evaluation.

Nilotinib is contraindicated in patients with known hypersensitivity to the drug or any of its excipients. Caution is also advised for individuals with uncontrolled cardiac disease, severe hepatic impairment, or those taking strong CYP3A4 inhibitors, unless a risk‑benefit assessment supports use.

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.