Product image of Nilotinib Zentiva Pharma Uk (Nilotinib) supplied by GNH India

Nilotinib Zentiva Pharma Uk

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib Zentiva Pharma Uk (Nilotinib)

Nilotinib, the active ingredient in Nilotinib Zentiva Pharma Uk, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats chronic myeloid leukemia in adult patients.

GNH India supplies Nilotinib Zentiva Pharma Uk as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Zentiva Pharma Uk Limited

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Indications & Clinical Uses

Nilotinib is indicated for the treatment of chronic myeloid leukemia, a BCR‑ABL driven hematologic malignancy.

  • Chronic myeloid leukemia (CML) – chronic phase: reduces disease progression and improves survival.
  • Chronic myeloid leukemia (CML) – accelerated phase: achieves hematologic and cytogenetic responses.
  • Chronic myeloid leukemia (CML) – blast phase: provides disease control when other therapies have failed.
  • CML after imatinib resistance: offers an alternative targeted therapy.
  • CML after imatinib intolerance: enables continued BCR‑ABL inhibition.

How It Works

  • Nilotinib selectively binds to the ATP‑binding site of the BCR‑ABL fusion protein, blocking its tyrosine‑kinase activity and downstream signaling that drives leukemic cell proliferation. The drug also inhibits related kinases such as c‑KIT and PDGFR, extending its antileukemic effect across multiple disease phases of chronic myeloid leukemia.

Side Effects

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

Common Side Effects

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

Serious or Rare Side Effects

  • Cardiovascular events: arterial occlusive disease, myocardial infarction.
  • Pancreatitis: inflammation of the pancreas, may be severe.
  • Severe hepatotoxicity: marked elevation of liver enzymes or hepatitis.
  • QT interval prolongation: risk of cardiac arrhythmia.

Precautions & Warnings

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

  • Cardiac monitoring: assess baseline ECG and monitor QT interval during therapy.
  • Hepatic function: evaluate liver enzymes before initiation and periodically thereafter.
  • Pancreatic enzymes: check amylase and lipase levels regularly.
  • Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors.
  • Pregnancy risk: contraindicated in pregnancy; ensure effective contraception for women of childbearing potential.
  • Store at ambient temperature: keep below 25 °C in the original container, 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): can markedly raise Nilotinib levels.
  • Proton pump inhibitors (e.g., omeprazole) taken concurrently: may reduce absorption and efficacy.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, St. John’s wort): may lower drug exposure.
  • Antacids or H2‑blockers taken within 2 hours of Nilotinib: can affect bioavailability.
  • Anticoagulants (e.g., warfarin): may require INR monitoring due to possible interaction.

Frequently Asked Questions

Nilotinib is a targeted anticancer medication used to treat chronic myeloid leukemia (CML) in adult patients. It is indicated for the chronic, accelerated, and blast phases of CML, as well as for cases where the disease is resistant or intolerant to first‑line therapy such as imatinib.

Nilotinib works by selectively inhibiting the BCR‑ABL tyrosine kinase, the abnormal enzyme that drives CML. By blocking the ATP‑binding site of BCR‑ABL, it stops downstream signaling that promotes leukemic cell growth. The drug also blocks related kinases like c‑KIT and PDGFR, enhancing its antileukemic activity.

The dose of Nilotinib is individualized and set by the prescribing physician based on the patient’s disease phase, prior therapy, and overall health. Only a qualified healthcare professional should determine the appropriate dosing regimen.

Nilotinib is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It is contraindicated during pregnancy, and women of childbearing potential must use effective contraception. Breastfeeding is not recommended while taking Nilotinib because the drug can be excreted in milk.

To order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. The team then replies with pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

The primary alternative to Nilotinib is imatinib, the first‑generation BCR‑ABL inhibitor. Nilotinib is a second‑generation agent with higher potency and activity against many imatinib‑resistant BCR‑ABL mutations. It often achieves faster and deeper molecular responses, though it may carry a different safety profile, including a higher risk of cardiovascular events.

Nilotinib tablets should be stored at ambient temperature, below 25 °C, in the original blister pack to protect from moisture and light. Keep the product out of reach of children and do not store in bathrooms or other humid environments.

Nilotinib is taken orally as a tablet, usually with a low‑fat meal or on an empty stomach as directed by the prescriber. The tablets should be swallowed whole with water and not crushed or chewed. Patients should follow the specific timing instructions provided by their healthcare professional.

Serious risks include cardiovascular events such as arterial occlusive disease or myocardial infarction, QT‑interval prolongation that can lead to arrhythmias, pancreatitis, and severe liver injury. Patients should report chest pain, palpitations, sudden abdominal pain, jaundice, or any signs of allergic reaction promptly.

Nilotinib should not be used by individuals with known hypersensitivity to the drug or any of its components. It is also contraindicated in pregnant women and should be avoided in patients with uncontrolled infections, severe hepatic impairment, or a history of significant cardiovascular disease unless the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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