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 an oral formulation for systemic use. It is indicated for the treatment of chronic myeloid leukemia and related BCR‑ABL positive disorders in adult patients.

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

Manufacturer / TM Owner

Stada Arzneimittel Ag

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 targets the BCR‑ABL driven pathway that underlies chronic myeloid leukemia and related hematologic malignancies.

  • Chronic myeloid leukemia (chronic phase): reduces leukemic cell proliferation and improves hematologic response.
  • Chronic myeloid leukemia (accelerated phase): helps achieve cytogenetic and molecular remission.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (in combination therapy): contributes to disease control and prolongs survival.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase by binding to its ATP‑binding site, thereby blocking downstream signaling cascades that drive uncontrolled proliferation of leukemic cells. The inhibition also affects related kinases such as KIT and PDGFR, contributing to its antineoplastic activity in BCR‑ABL positive malignancies.

Side Effects

Common side effects are generally mild to moderate and may affect treatment tolerability.

Common Side Effects

  • Nausea: occasional upset stomach or vomiting.
  • Diarrhea: loose stools that may require fluid replacement.
  • Rash: mild skin irritation or erythema.
  • Fatigue: feeling unusually tired or weak.

Serious or Rare Side Effects

  • QT interval prolongation: may lead to cardiac arrhythmias and requires ECG monitoring.
  • Hepatic toxicity: elevated liver enzymes or hepatitis.
  • Pancreatitis: abdominal pain with elevated pancreatic enzymes.

Precautions & Warnings

Nilotinib requires careful monitoring and patient education to minimize risks.

  • Cardiac monitoring: obtain baseline ECG and periodically assess QT interval.
  • Hepatic function: check liver enzymes before initiation and during therapy.
  • Electrolyte balance: correct hypokalemia and hypomagnesemia to reduce QT risk.
  • Drug interactions: avoid concomitant strong CYP3A4 inhibitors and QT‑prolonging agents.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Nilotinib has several clinically relevant drug interactions that may alter its exposure or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase nilotinib levels and risk of toxicity.
  • QT‑prolonging agents (e.g., macrolide antibiotics, fluoroquinolones): additive cardiac risk.
  • Antacids or supplements that raise gastric pH: markedly reduce nilotinib absorption.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower nilotinib exposure and reduce efficacy.
  • Warfarin: nilotinib can affect INR; monitor coagulation parameters regularly.

Frequently Asked Questions

Nilotinib Stada is used to treat chronic myeloid leukemia and related BCR‑ABL positive blood cancers in adult patients. It works by inhibiting the abnormal tyrosine kinase that drives the growth of leukemic cells, helping to achieve hematologic and molecular remission.

Nilotinib binds to the ATP‑binding site of the BCR‑ABL tyrosine kinase, preventing the enzyme from activating downstream signaling pathways that promote cell division. By blocking this activity, the drug reduces the proliferation of malignant leukemic cells and can also affect related kinases such as KIT and PDGFR.

The specific dose of Nilotinib Stada is determined by the prescribing physician based on the patient’s clinical condition, disease phase, and tolerability. Healthcare professionals adjust the regimen according to approved guidelines and individual 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. Patients should discuss reproductive plans with their healthcare provider.

To order Nilotinib Stada, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies 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 offering higher potency and selectivity than first‑generation agents such as imatinib. It is often chosen for patients who are resistant or intolerant to earlier therapies, providing faster and deeper molecular responses in many cases.

Nilotinib Stada should be stored at room temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid exposing it to extreme temperatures.

Nilotinib Stada is taken orally, usually as a tablet, with a low‑fat meal to improve absorption. Patients should swallow the tablet whole with water and follow the dosing schedule prescribed by their clinician.

The most serious risks include QT interval prolongation, which can lead to potentially life‑threatening arrhythmias, as well as severe liver toxicity, pancreatitis, and significant hematologic abnormalities such as neutropenia or thrombocytopenia. Regular monitoring is essential.

Patients with a known hypersensitivity to nilotinib or any of its excipients should avoid the product. It is also contraindicated in individuals with a history of prolonged QT interval, uncontrolled cardiac disease, or severe hepatic impairment without close supervision.

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.