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 is indicated for chronic myeloid leukemia (CML) that is resistant to or intolerant of prior therapy, providing a targeted option for patients who have limited alternatives.

GNH India supplies Nilotinib Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, transplant units and pharmacies worldwide, ensuring quality and regulatory compliance across global markets. The company follows stringent quality standards and provides reliable logistics for timely delivery.

Manufacturer / TM Owner

Teva Gmbh

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Indications & Clinical Uses

Nilotinib is a tyrosine kinase inhibitor used in the management of chronic myeloid leukemia, a myeloproliferative disorder driven by BCR‑ABL fusion protein activity.

  • Chronic myeloid leukemia (CML) resistant or intolerant to prior therapy: provides disease control by targeting BCR‑ABL mutations that are not responsive to earlier treatments.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, including many mutations that confer resistance to imatinib. By blocking this enzyme, it prevents downstream signaling pathways that drive proliferation and survival of leukemic cells, leading to reduced tumor growth and increased apoptosis of malignant clones.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools.
  • Rash: skin redness or itching.
  • Fatigue: feeling unusually tired.

Serious or Rare Side Effects

  • QT interval prolongation: may affect heart rhythm.
  • Pancreatitis: inflammation of the pancreas.
  • Severe neutropenia: markedly low white blood cell count.

Precautions & Warnings

Before initiating therapy, clinicians should consider the following precautions:

  • Cardiac monitoring: assess baseline ECG and correct electrolyte abnormalities.
  • Hematologic monitoring: perform regular complete blood counts.
  • Hepatic function: check liver enzymes periodically.
  • Pregnancy risk: avoid use in pregnancy; category D.
  • Drug‑specific warnings: counsel patients on signs of QT prolongation.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Nilotinib may interact with several medicines; careful review is required.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nilotinib exposure.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
  • QT‑prolonging agents (e.g., amiodarone, sotalol): increase risk of cardiac arrhythmia.

Moderate Interactions (Monitor Closely)

  • Antacids containing aluminum or magnesium: can lower absorption; separate dosing by at least 2 hours.
  • Certain statins (e.g., simvastatin, lovastatin): may increase statin levels; consider dose adjustment or alternative lipid‑lowering therapy.

Frequently Asked Questions

Nilotinib Teva is prescribed for patients with chronic myeloid leukemia (CML) who have disease that is resistant to or cannot tolerate prior tyrosine kinase inhibitor therapy. It targets the BCR‑ABL protein that drives leukemic cell growth, offering a therapeutic option when earlier treatments fail.

Nilotinib blocks the activity of the BCR‑ABL tyrosine kinase, including many mutant forms that are not inhibited by imatinib. By preventing this enzyme from signaling, the drug stops the proliferation of leukemic cells and promotes their programmed death, thereby controlling disease progression.

The dosage of Nilotinib Teva is determined by the prescribing physician based on the individual patient's clinical condition, prior therapy, and tolerance. Only a qualified healthcare professional can set the appropriate dose and schedule.

Nilotinib is classified as pregnancy category D, indicating evidence of risk to the fetus. It should not be used during pregnancy unless the potential benefit justifies the risk. Breastfeeding is not recommended while taking nilotinib because the drug may be excreted in milk.

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 is a second‑generation BCR‑ABL inhibitor that retains activity against many imatinib‑resistant mutations. Compared with first‑generation agents, it often provides deeper molecular responses but may have a different safety profile, including a higher risk of QT prolongation, requiring individualized risk‑benefit assessment.

Store Nilotinib Teva tablets at room temperature, below 25 °C, in the original blister pack or container. Protect the product from moisture, excessive heat and direct sunlight to maintain its stability and potency.

Nilotinib Teva is taken orally, usually as whole tablets with a low‑fat meal. Patients should swallow the tablet whole with water and follow the dosing schedule prescribed by their healthcare provider, ensuring consistent timing with respect to meals.

The most serious adverse events include QT interval prolongation, which can lead to life‑threatening arrhythmias, severe neutropenia that raises infection risk, and pancreatitis. Patients should be monitored regularly for cardiac, hematologic and pancreatic abnormalities.

Nilotinib should be avoided in patients with a known hypersensitivity to the drug, those with a prolonged QT interval, uncontrolled cardiac disease, or severe hepatic impairment. It is also contraindicated during pregnancy and should be used with caution in breastfeeding women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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