Product image of Nilotinib Teva Uk Limited (Nilotinib Hydrochloride Dihydrate) supplied by GNH India

Nilotinib Teva Uk Limited

Active Ingredient:
Nilotinib Hydrochloride Dihydrate
Origin:
EU

Nilotinib Teva Uk Limited (Nilotinib Hydrochloride Dihydrate)

Nilotinib, the active ingredient in Nilotinib Teva Uk Limited, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for the treatment of chronic myeloid leukemia in adult patients, targeting the BCR‑ABL fusion protein that drives malignant cell proliferation.

GNH India supplies Nilotinib Teva Uk Limited 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 documentation to support import and distribution across multiple regions.

Manufacturer / TM Owner

Teva Uk Limited

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Indications & Clinical Uses

Nilotinib is used to target BCR‑ABL–positive leukemias, primarily chronic myeloid leukemia.

  • Chronic phase CML: reduces disease burden and prolongs survival in adult patients.
  • Accelerated phase CML: helps achieve hematologic and cytogenetic responses.
  • Blast phase CML: provides disease control when combined with other therapies.

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. The drug also exhibits activity against several other kinases, including KIT and PDGFR, contributing to its antineoplastic effects. By maintaining inhibition over prolonged periods, nilotinib sustains suppression of malignant clone expansion.

Side Effects

Nilotinib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Diarrhea: loose stools.
  • Fatigue: general tiredness.
  • Rash: skin irritation.

Serious or Rare Side Effects

  • Cardiovascular events: including arterial occlusion, myocardial infarction.
  • Hepatotoxicity: elevated liver enzymes or hepatitis.
  • Pancreatitis: inflammation of the pancreas.

Precautions & Warnings

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

  • Cardiac assessment: evaluate history of arterial disease before initiating therapy.
  • Liver function monitoring: check hepatic enzymes regularly during treatment.
  • Electrolyte balance: monitor serum potassium and magnesium levels.
  • Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors.
  • Pregnancy and lactation: contraindicated in pregnancy; advise effective contraception and avoid breastfeeding.
  • Store at ambient temperature: keep tablets below 25 °C in original packaging, protected 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, risking severe adverse events.
  • Proton pump inhibitors (e.g., omeprazole) taken concomitantly: reduce absorption and efficacy.
  • Antacids containing aluminum or magnesium: decrease oral bioavailability.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower nilotinib exposure, reducing effectiveness.
  • Anticoagulants (e.g., warfarin): may require dose adjustment and INR monitoring.
  • Statins metabolized by CYP3A4 (e.g., simvastatin): increased risk of myopathy, consider alternative lipid‑lowering agents.

Frequently Asked Questions

Nilotinib Teva Uk Limited is an oral tyrosine kinase inhibitor indicated for the treatment of chronic myeloid leukemia (CML) in adult patients. It targets the BCR‑ABL fusion protein that drives malignant cell growth, helping to control disease progression and improve survival outcomes.

Nilotinib works by binding to the ATP‑binding site of the BCR‑ABL tyrosine kinase, blocking its activity. This inhibition stops downstream signaling that leads to uncontrolled proliferation of leukemic cells. The drug also inhibits other kinases such as KIT and PDGFR, adding to its antineoplastic effect.

The dose of nilotinib is determined by the prescribing physician based on the patient’s disease phase, overall health, liver function, and potential drug interactions. Dosage adjustments may be required for patients with hepatic impairment or those taking concomitant medications that affect nilotinib metabolism.

Nilotinib is classified as pregnancy category unknown and is generally not recommended for use during pregnancy or lactation. Women of childbearing potential should use effective contraception during treatment and for a defined period after discontinuation, and breastfeeding should be avoided.

To 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 the necessary import documentation.

The primary alternative to nilotinib is imatinib, another BCR‑ABL inhibitor. Nilotinib is more potent against certain BCR‑ABL mutations and often achieves faster and deeper molecular responses, but it may have a higher incidence of cardiovascular and metabolic side effects. Choice of therapy depends on mutation profile, patient comorbidities and physician judgment.

Nilotinib tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack. They must be kept away from moisture, direct sunlight and excessive heat to maintain potency throughout the shelf life.

Nilotinib is taken orally, usually twice daily on an empty stomach (at least one hour before or two hours after a meal). The tablets should be swallowed whole with a glass of water and not crushed or chewed. Patients must follow the dosing schedule prescribed by their healthcare provider.

Serious risks include cardiovascular events such as arterial occlusion or myocardial infarction, hepatotoxicity manifested by elevated liver enzymes or hepatitis, and pancreatitis. Patients should be monitored regularly for signs of chest pain, liver dysfunction, abdominal pain, or unexplained nausea and report any concerning symptoms promptly.

Nilotinib should be avoided in patients with a known hypersensitivity to the drug or any of its excipients, in those with uncontrolled cardiovascular disease, and in pregnant or breastfeeding women. Caution is also advised for individuals with severe hepatic impairment or those taking strong CYP3A4 inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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