Product image of Nilotinib supplied by GNH India

Nilotinib

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib

Nilotinib, the active ingredient in Nilotinib, is a tyrosine kinase inhibitor presented as a tablet for oral use. It is indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome‑positive acute lymphoblastic leukemia in adult patients.

GNH India supplies Nilotinib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with distribution originating from the European Union market. All batches meet EU GMP standards and are exported under controlled conditions, ensuring product quality and traceability.

Manufacturer / TM Owner

Viatris Limited

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Indications & Clinical Uses

  • Nilotinib targets malignant cells driven by BCR‑ABL and related kinases, making it a key therapy in specific blood cancers.
  • Chronic myeloid leukemia (CML) – chronic phase: controls leukemic cell proliferation and prolongs survival.
  • CML – accelerated phase: reduces disease burden and delays progression.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): induces remission and extends overall survival.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase as well as KIT and PDGFR receptors. By blocking these signaling pathways, it prevents phosphorylation events that drive malignant cell growth and survival, leading to reduced proliferation of leukemic cells and promotion of apoptosis in affected tissues.

Side Effects

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Diarrhea: loose stools, often transient.
  • Rash: skin irritation or erythema.
  • Headache: mild to moderate intensity.
  • Fatigue: general tiredness.
  • Myalgia: muscle aches.

Serious or Rare Side Effects

  • QT interval prolongation: may cause cardiac arrhythmias.
  • Pancreatitis: inflammation of the pancreas, presenting with abdominal pain.
  • Severe hepatic injury: elevated liver enzymes or hepatitis.
  • Grade 3/4 neutropenia: marked reduction in neutrophils.
  • Grade 3/4 thrombocytopenia: low platelet counts.
  • Anaphylactic reactions: rare but potentially life‑threatening hypersensitivity.

Precautions & Warnings

  • Nilotinib requires careful monitoring and patient education before and during therapy.
  • Cardiac monitoring: baseline ECG and periodic QT interval assessment due to risk of QT prolongation.
  • Hepatic function: monitor liver enzymes because of potential hepatotoxicity.
  • Pancreatic enzymes: check amylase/lipase periodically for pancreatitis risk.
  • Blood counts: regular CBC to detect neutropenia or thrombocytopenia.
  • Drug interactions: avoid concomitant strong CYP3A4 inhibitors.
  • Pregnancy: contraindicated in pregnancy (Category D); advise effective contraception.
  • Store at ambient temperature: keep tablets in original container, protect from moisture and light.

Avoid Interactions

Nilotinib may interact with several medicines that affect its metabolism or cardiac safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib exposure.
  • QT‑prolonging agents (e.g., amiodarone, sotalol): additive risk of arrhythmia.
  • Antacids containing aluminum or magnesium: reduce nilotinib absorption.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, phenytoin): may lower nilotinib levels.
  • Warfarin: potential alteration of INR, monitor coagulation.
  • Statins metabolized by CYP3A4 (e.g., simvastatin): increased statin exposure, consider dose adjustment.
  • Digoxin: possible increase in serum concentration, monitor levels.

Frequently Asked Questions

Nilotinib is prescribed for adult patients with chronic myeloid leukemia (CML) in chronic, accelerated, or blast phases, and for Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL). It targets the BCR‑ABL kinase that drives these blood cancers, helping to control disease progression and improve survival outcomes.

Nilotinib selectively blocks the BCR‑ABL tyrosine kinase as well as KIT and PDGFR receptors. By inhibiting these enzymes, it stops downstream signaling that promotes malignant cell growth and survival, leading to reduced proliferation of leukemic cells and increased programmed cell death.

The exact dose of Nilotinib is determined by the prescribing physician based on the patient’s disease phase, weight, liver function, and other clinical factors. While a common starting regimen may be 300 mg taken twice daily, the final dosing schedule must be individualized and confirmed by a qualified healthcare professional.

Nilotinib is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It is contraindicated during pregnancy, and effective contraception is required for both men and women of reproductive potential. Use while breastfeeding is not recommended because the drug can be excreted in breast milk.

To request Nilotinib, 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 import documentation.

Nilotinib is a second‑generation tyrosine kinase inhibitor offering higher potency against BCR‑ABL than the first‑generation drug imatinib. Compared with another second‑generation agent, dasatinib, nilotinib has a different safety profile—more QT‑prolongation risk but less pleural effusion. Choice of therapy depends on disease characteristics, prior treatment, and patient tolerance.

Store Nilotinib tablets at ambient temperature, below 25 °C, in the original blister pack or container. Protect them from moisture, excessive heat, and direct light. Do not store in the bathroom or near a kitchen sink. Keep out of reach of children and dispose of any unused tablets according to local regulations.

Nilotinib is taken orally as a tablet, usually on an empty stomach—at least one hour before or two hours after a meal—to ensure optimal absorption. The tablets should be swallowed whole with a full glass of water and not crushed or chewed. Patients should follow the dosing schedule prescribed by their healthcare provider.

The most critical safety concerns include QT interval prolongation, which can lead to serious heart rhythm disturbances; severe liver injury indicated by marked elevation of liver enzymes; pancreatitis presenting with abdominal pain; and profound reductions in blood cell counts such as neutropenia or thrombocytopenia. Prompt medical attention is required if any of these symptoms arise.

Nilotinib should be avoided in patients with known hypersensitivity to the drug, those with a prolonged QT interval, severe hepatic impairment, or uncontrolled infections. It is also contraindicated during pregnancy and is not recommended for breastfeeding mothers. Physicians must evaluate each individual’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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