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

Nilotinib Viatris

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib Viatris (Nilotinib)

Nilotinib, the active ingredient in Nilotinib Viatris, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It treats chronic myeloid leukemia and Philadelphia chromosome‑positive acute lymphoblastic leukemia in adult patients.

GNH India supplies Nilotinib Viatris 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 therapy used in hematologic malignancies that involve the BCR‑ABL fusion protein.

  • Chronic myeloid leukemia (CML): Reduces leukemic cell proliferation and helps achieve hematologic and cytogenetic remission.
  • Accelerated phase CML: Controls disease progression and improves overall survival.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): Contributes to remission when incorporated into combination regimens.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, a constitutively active enzyme generated by the Philadelphia chromosome translocation. By blocking this kinase, downstream signaling pathways that drive uncontrolled proliferation, survival, and migration of leukemic cells are interrupted, leading to reduced tumor growth and increased apoptosis of malignant clones.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: watery stools often occurring early in therapy.
  • Rash: maculopapular skin eruptions.
  • Elevated liver enzymes: transient increases in ALT/AST.
  • Fatigue: generalized tiredness without clear cause.

Serious or Rare Side Effects

  • Cardiovascular events: including arterial occlusion or ischemic heart disease.
  • Pancreatitis: acute inflammation of the pancreas presenting with abdominal pain.
  • Severe hepatotoxicity: marked elevation of liver enzymes with possible jaundice.
  • QT interval prolongation: potential for arrhythmias requiring ECG monitoring.

Precautions & Warnings

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

  • Cardiac assessment: evaluate baseline cardiovascular risk and monitor for ischemic events.
  • Hepatic function: check liver enzymes regularly and adjust therapy if significant elevation occurs.
  • Electrolyte balance: maintain normal potassium and magnesium levels to reduce QT prolongation risk.
  • Drug interactions: review concomitant medications for CYP3A4 inhibitors or inducers.
  • Pregnancy and lactation: avoid use unless benefits outweigh potential fetal or infant risks.
  • 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, affecting its concentration or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib exposure and toxicity.
  • Proton pump inhibitors: can reduce nilotinib absorption, compromising efficacy.
  • Anticoagulants (e.g., warfarin): heightened risk of bleeding due to altered metabolism.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower nilotinib levels, reducing effectiveness.
  • Statins metabolized by CYP3A4 (e.g., simvastatin): increased risk of myopathy; consider dose adjustment.
  • Antacids containing aluminum or magnesium: may affect nilotinib bioavailability; separate dosing times.

Frequently Asked Questions

Nilotinib Viatris is indicated for the treatment of chronic myeloid leukemia (CML) in chronic, accelerated, and blast phases, as well as for Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL). It is used in adult patients to control disease progression and achieve remission when prescribed by a qualified oncologist.

Nilotinib selectively blocks the BCR‑ABL tyrosine kinase, an abnormal enzyme produced by the Philadelphia chromosome translocation. Inhibiting this kinase disrupts downstream signaling pathways that promote leukemic cell growth and survival, leading to reduced proliferation and increased programmed cell death of malignant cells.

The specific dose of Nilotinib Viatris is determined by the prescribing physician based on the patient’s disease stage, prior therapy, and individual health factors. Dosage adjustments may be required for renal or hepatic impairment, and the prescriber will provide detailed instructions tailored to each patient.

Safety data for nilotinib in pregnancy and lactation are limited. The drug should only be used if the potential benefit justifies the potential risk to the fetus or infant. Women of childbearing potential should use effective contraception, and breastfeeding is generally not recommended while on therapy.

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 offering higher potency and selectivity compared with first‑generation agents like imatinib. Clinical studies show faster and deeper molecular responses in many patients, though safety profiles differ, with nilotinib associated with a higher incidence of cardiovascular events that require monitoring.

Nilotinib Viatris tablets should be stored at ambient temperature, below 25 °C. Keep the product in its original container, protect it from moisture, excessive heat, and direct sunlight. Do not refrigerate or freeze the tablets, as temperature extremes may affect stability.

Nilotinib Viatris is taken orally, usually as whole tablets with a moderate‑fat meal to enhance absorption. Patients should swallow the tablets whole with water and follow the dosing schedule prescribed by their healthcare provider, typically twice daily, unless otherwise directed.

The most serious risks include cardiovascular events such as arterial occlusion, QT interval prolongation leading to arrhythmias, severe hepatotoxicity, and pancreatitis. Patients should be monitored regularly for cardiac symptoms, liver function abnormalities, and electrolyte disturbances, and any concerning signs should prompt immediate medical evaluation.

Nilotinib is contraindicated in patients with known hypersensitivity to nilotinib or any of its excipients. It should also be avoided in individuals with uncontrolled cardiovascular disease, severe hepatic impairment, or those taking strong CYP3A4 inhibitors that cannot be discontinued. Clinical judgment is essential for each case.

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.