Product image of Nilotinib Stada 150 Mg Tvrdé Tobolky (Nilotinib) supplied by GNH India

Nilotinib Stada 150 Mg Tvrdé Tobolky

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib Stada 150 Mg Tvrdé Tobolky (Nilotinib)

Nilotinib, the active ingredient in Nilotinib Stada 150 Mg Tvrdé Tobolky, is a tyrosine kinase inhibitor presented as a 150 mg tablet for oral use. It is indicated for the treatment of chronic myeloid leukemia in the chronic phase in adult patients.

GNH India supplies Nilotinib Stada 150 Mg Tvrdé Tobolky 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‑ready documentation for importers, ensuring timely delivery and compliance with local regulations.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Nilotinib is a targeted tyrosine kinase inhibitor used in the management of Philadelphia chromosome‑positive chronic myeloid leukemia.

  • Chronic Myeloid Leukemia (chronic phase): reduces leukemic cell proliferation and improves long‑term survival.
  • Chronic Myeloid Leukemia (accelerated phase): provides disease control when prior therapy is insufficient.
  • Philadelphia chromosome‑positive CML after prior therapy: offers an alternative oral option for patients resistant or intolerant to first‑line treatment.

How It Works

  • Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase by binding to its ATP‑binding site, thereby blocking downstream signaling pathways that drive proliferation and survival of leukemic cells. It also inhibits the related kinases KIT and PDGFR, contributing to its antineoplastic activity in Philadelphia chromosome‑positive chronic myeloid leukemia. By maintaining inhibition of BCR‑ABL signaling, nilotinib prevents the transcription of genes involved in cell‑cycle progression and reduces angiogenic factor production.

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.
  • Rash: skin irritation or redness.
  • Fatigue: feeling of tiredness.

Serious or Rare Side Effects

  • QT prolongation: heart rhythm disturbance that can lead to arrhythmia.
  • Pancreatitis: inflammation of the pancreas with abdominal pain.
  • Hepatic failure: severe liver enzyme elevation and dysfunction.
  • Severe neutropenia: markedly reduced white blood cell count increasing infection risk.

Precautions & Warnings

When prescribing nilotinib, clinicians should observe several safety measures to minimize risks.

  • ECG monitoring: perform baseline and periodic ECGs to detect QT prolongation.
  • Liver function tests: assess hepatic enzymes before and during therapy.
  • Blood count monitoring: check complete blood count regularly for neutropenia or thrombocytopenia.
  • Avoid concomitant QT‑prolonging drugs: reduce risk of cardiac arrhythmias.
  • Dose adjustment in hepatic impairment: use caution and consider lower doses in patients with liver dysfunction.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Nilotinib interacts with several medicines, requiring careful management of co‑administered drugs.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nilotinib plasma levels.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce nilotinib effectiveness.
  • QT‑prolonging agents (e.g., quinidine, amiodarone): increase risk of cardiac arrhythmias.

Moderate Interactions (Monitor Closely)

  • Antacids containing aluminum or magnesium: can decrease nilotinib absorption; separate dosing by at least 2 hours.
  • CYP3A4 substrate drugs (e.g., midazolam, tacrolimus): may have altered exposure.
  • Warfarin: monitor INR closely as nilotinib may affect anticoagulation.

Frequently Asked Questions

Nilotinib Stada 150 Mg Tvrdé Tobolky is an oral tyrosine kinase inhibitor indicated for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase. It targets the BCR‑ABL fusion protein that drives leukemic cell growth, helping to achieve disease control and improve survival outcomes.

Nilotinib works by selectively binding to the ATP‑binding site of the BCR‑ABL tyrosine kinase, blocking its activity. This inhibition stops downstream signaling pathways that promote proliferation and survival of leukemic cells. The drug also inhibits related kinases such as KIT and PDGFR, contributing to its antineoplastic effect in Philadelphia chromosome‑positive CML.

The specific dose of nilotinib is determined by the prescribing physician based on the patient’s clinical condition, prior therapies, and tolerability. Dosing recommendations are provided in the product’s prescribing information, and adjustments may be required for factors such as liver function, drug interactions, or adverse events.

The safety of nilotinib during pregnancy or while breastfeeding has not been established. It is classified as contraindicated for use in pregnant women unless the potential benefit justifies the risk to the fetus. Women of child‑bearing potential should use effective contraception, and nursing mothers should discuss alternatives with their healthcare provider.

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

Nilotinib is a second‑generation BCR‑ABL inhibitor that offers higher potency and selectivity compared with first‑generation agents such as imatinib. Clinical studies have shown faster and deeper molecular responses in many patients, especially those who are resistant or intolerant to imatinib. However, nilotinib carries a distinct safety profile, including a higher risk of QT prolongation, which must be considered when selecting therapy.

Store the tablets at below 25 °C (77 °F) in their original container, protecting them from moisture, heat and direct sunlight. Keep the packaging tightly closed and avoid exposure to humidity. Do not refrigerate or freeze the tablets, and keep them out of reach of children.

Nilotinib is taken orally, usually as whole tablets swallowed with a moderate‑fat meal to improve absorption. The medication should be taken at the same times each day, and patients are advised not to crush, split, or chew the tablets. Water is the preferred fluid for ingestion, and dosing intervals should be maintained consistently.

The most serious risks include QT interval prolongation, which can lead to life‑threatening arrhythmias; severe hepatic toxicity; pancreatitis; and profound neutropenia or thrombocytopenia that increase infection or bleeding risk. Patients should be monitored regularly with ECGs, liver function tests, pancreatic enzymes, and complete blood counts to detect these events early.

Nilotinib should not be used by patients with a known hypersensitivity to the drug or any of its excipients. It is also contraindicated in individuals with a history of significant QT prolongation, uncontrolled cardiac arrhythmias, or severe hepatic impairment. Clinicians must evaluate each patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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