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 an oral tablet for oral use. It is indicated for the treatment of chronic myeloid leukemia in patients who are in the chronic or accelerated phase.
GNH India supplies Nilotinib Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Teva Gmbh

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Indications & Clinical Uses

Nilotinib is a targeted therapy used within the chronic myeloid leukemia (CML) disease pathway.

  • Chronic phase CML: reduces leukemic cell proliferation and helps achieve hematologic and cytogenetic remission.
  • Accelerated phase CML: provides disease control when the disease progresses beyond the chronic phase.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, a fusion protein that drives uncontrolled cell growth in Philadelphia chromosome‑positive leukemia. By binding to the ATP‑binding site of BCR‑ABL, it blocks downstream signaling pathways responsible for proliferation and survival of leukemic cells, leading to apoptosis and disease control.

Side Effects

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

Common Side Effects

  • Rash: mild to moderate skin eruptions.
  • Nausea: occasional upset stomach.
  • Diarrhea: loose stools, often transient.
  • Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects

  • Cardiovascular events: including arterial occlusion or ischemia.
  • Pancreatitis: inflammation of the pancreas.
  • Severe hepatic impairment: marked liver dysfunction.
  • QT interval prolongation: potential cardiac rhythm disturbance.

Precautions & Warnings

Patients should be monitored for specific safety considerations while receiving Nilotinib.

  • Cardiac monitoring: assess for signs of arterial occlusive disease.
  • Liver function: check hepatic enzymes regularly.
  • Electrolytes: maintain potassium and magnesium within normal ranges to reduce QT risk.
  • Drug interactions: review concomitant medications for CYP3A4 inhibitors or inducers.
  • Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture.

Avoid Interactions

Nilotinib can interact with other medicines, influencing its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase Nilotinib exposure.
  • Antacids containing aluminum or magnesium: can reduce absorption.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower drug levels.
  • Proton pump inhibitors: may modestly affect bioavailability.

Frequently Asked Questions

Nilotinib Teva is used to treat chronic myeloid leukemia (CML) in patients who are in the chronic or accelerated phase. It works by targeting the BCR‑ABL protein that drives the disease, helping to control leukemic cell growth.

Nilotinib selectively blocks the BCR‑ABL tyrosine kinase, preventing the enzyme from activating downstream pathways that promote cell proliferation and survival. This inhibition leads to reduced growth of leukemic cells and can induce remission in CML.

The prescribed dose of Nilotinib Teva is determined by the treating physician based on the patient’s clinical condition, disease phase, and other individual factors. Dosing instructions are provided on the prescription label.

The safety of Nilotinib in pregnancy or while breastfeeding 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 or infant.

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 and any necessary import documentation.

Nilotinib belongs to the tyrosine kinase inhibitor class, similar to imatinib and dasatinib. Compared with first‑generation inhibitors, Nilotinib offers higher potency against BCR‑ABL and may be used when resistance or intolerance to earlier agents occurs.

Nilotinib Teva tablets should be stored at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Do not store in a refrigerator or freezer.

Nilotinib Teva is taken orally, usually as whole tablets with a moderate‑fat meal. The exact administration schedule, including timing relative to meals, is defined by the prescribing clinician.

Serious risks include cardiovascular events such as arterial occlusion, severe liver toxicity, pancreatitis, and QT interval prolongation, which can lead to dangerous heart rhythm disturbances. Patients should be monitored regularly for these conditions.

Patients with known hypersensitivity to Nilotinib or any of its excipients should avoid the drug. It is also contraindicated in individuals with uncontrolled cardiac disease, severe hepatic impairment, or those taking prohibited strong CYP3A4 inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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