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

Nilotinib Teva

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib Teva (Nilotinib)

Nilotinib, the active ingredient in Nilotinib Teva, is a tyrosine kinase inhibitor presented as a tablet for oral use. It targets the BCR‑ABL protein and is used to treat chronic myeloid leukemia in adult patients. It is approved in the European Union and is indicated for patients with chronic phase or accelerated phase disease who are resistant or intolerant to prior therapy.

GNH India supplies Nilotinib Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet global demand.

Manufacturer / TM Owner

Teva Gmbh

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Indications & Clinical Uses

Nilotinib acts on the BCR‑ABL tyrosine kinase pathway, a key driver in chronic myeloid leukemia.

  • Chronic phase CML: reduces leukemic cell proliferation and achieves deep molecular response.
  • Accelerated phase CML: provides disease control in patients resistant or intolerant to prior therapy.
  • CML after imatinib resistance or intolerance: offers an alternative targeted treatment option.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase by binding to its ATP‑binding site, preventing phosphorylation of downstream substrates. This blockade halts the signaling cascade that drives uncontrolled proliferation of leukemic cells, leading to apoptosis and reduced disease progression. The drug also inhibits related kinases such as KIT and PDGFR, contributing to its antineoplastic activity. By maintaining high intracellular concentrations, nilotinib ensures sustained inhibition of the target kinase throughout the dosing interval.

Side Effects

Nilotinib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea
  • Diarrhea
  • Rash
  • Fatigue

Serious or Rare Side Effects

  • QT interval prolongation
  • Pancreatitis
  • Hepatic toxicity

Precautions & Warnings

When prescribing nilotinib, clinicians should observe several precautionary measures to minimize risk.

  • ECG monitoring: assess QT interval before initiation and periodically during therapy.
  • Liver function tests: monitor transaminases and bilirubin regularly.
  • Blood counts: perform complete blood count to detect neutropenia or thrombocytopenia.
  • Concomitant QT‑prolonging agents: avoid co‑administration whenever possible.
  • Hepatic impairment: use with caution and consider dose adjustment in moderate to severe liver disease.
  • Store at below 25°C: keep in the original packaging, protect from moisture and light.

Avoid Interactions

Nilotinib interacts with several medicines that can alter its plasma concentration or increase toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nilotinib levels and risk of QT prolongation.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): can lower nilotinib exposure and reduce efficacy.
  • Other QT‑prolonging drugs (e.g., amiodarone, sotalol): increase the chance of cardiac arrhythmias.

Moderate Interactions (Monitor Closely)

  • Digoxin: nilotinib may increase digoxin concentrations; monitor serum levels.
  • Warfarin: potential alteration of INR; check coagulation parameters regularly.

Frequently Asked Questions

Nilotinib Teva contains the active ingredient nilotinib, a targeted therapy used to treat chronic myeloid leukemia (CML). It is prescribed for adult patients with chronic‑phase or accelerated‑phase disease, especially when they have shown resistance or intolerance to prior tyrosine‑kinase inhibitors.

Nilotinib works by selectively binding to the ATP‑binding site of the BCR‑ABL tyrosine kinase, blocking its activity. This inhibition stops downstream signaling that drives uncontrolled growth of leukemic cells, leading to reduced proliferation and increased apoptosis of the malignant clone.

The exact dose of nilotinib is determined by the prescribing physician based on the patient’s clinical condition, prior therapy, and laboratory parameters. Dosing instructions are provided on the prescription label and should be followed exactly as directed by the healthcare professional.

The safety of nilotinib in pregnancy and lactation has not been established. It is classified as pregnancy category unknown, and the drug should only be used if the potential benefit justifies the potential risk to the fetus. Breastfeeding is not recommended while on therapy.

To place an order, 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 that offers higher potency and selectivity compared with first‑generation agents such as imatinib. Clinical studies have shown faster and deeper molecular responses, though the safety profile includes a higher risk of QT prolongation, requiring cardiac monitoring.

Nilotinib tablets should be stored at temperatures below 25 °C (77 °F). Keep them in the original blister pack, protect from moisture and direct light, and store out of reach of children.

Nilotinib is taken orally, usually as whole tablets swallowed with a moderate‑fat meal to improve absorption. Patients should follow the dosing schedule prescribed by their physician and avoid crushing or chewing the tablets.

The most serious adverse events include QT interval prolongation, which can lead to life‑threatening arrhythmias, severe hepatic toxicity, and pancreatitis. Regular ECG monitoring, liver function tests, and clinical assessment are essential to detect these risks early.

Nilotinib is contraindicated in patients with a known hypersensitivity to the drug or any of its excipients, and in individuals with a baseline prolonged QT interval. Caution is also advised for patients with significant hepatic impairment or uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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