Product image of Nintedanib Onkogen (Nintedanib) supplied by GNH India

Nintedanib Onkogen

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Onkogen (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Onkogen, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, non‑small cell lung cancer, and other solid tumours in adult patients.

GNH India supplies Nintedanib Onkogen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with a focus on quality assurance, regulatory compliance, and reliable logistics to meet global demand across diverse therapeutic areas.

Manufacturer / TM Owner

Onkogen Kft.

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Indications & Clinical Uses

  • Nintedanib is used in diseases characterized by fibrosis or uncontrolled cell growth, targeting pathways that drive tissue scarring and tumor angiogenesis. These approved indications reflect the drug’s antifibrotic and antineoplastic properties demonstrated in clinical trials.
  • Idiopathic pulmonary fibrosis: slows disease progression by reducing fibroblast activity and extracellular matrix deposition.
  • Non‑small cell lung cancer: inhibits tumor angiogenesis and proliferation, contributing to disease control in eligible patients.
  • Other solid tumours: may be employed as part of combination regimens to limit tumour vascularisation and growth.

How It Works

  • Nintedanib blocks the intracellular kinase activity of multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR 1‑3), fibroblast growth factor receptors (FGFR 1‑3) and platelet‑derived growth factor receptors (PDGFR‑α/β). By preventing ligand‑induced autophosphorylation, it suppresses downstream signaling pathways that promote endothelial cell proliferation, fibroblast activation, and extracellular matrix production, thereby reducing angiogenesis and fibrotic remodeling in affected tissues, limiting pathological vessel formation and scar tissue development.

Side Effects

Nintedanib may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: feeling of sickness that may lead to reduced oral intake.
  • Diarrhea: frequent loose stools, sometimes requiring hydration.
  • Vomiting: episodes of expelling stomach contents.
  • Decreased appetite: reduced desire to eat, potentially affecting weight.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or liver injury requiring monitoring.
  • Arterial thromboembolism: blood clots in arteries that can cause stroke or heart attack.
  • Severe bleeding: gastrointestinal or other bleeding events.
  • Gastrointestinal perforation: hole formation in the stomach or intestines.

Precautions & Warnings

When prescribing Nintedanib, clinicians should observe several precautionary measures to minimise risks.

  • Liver function monitoring: assess baseline enzymes and repeat periodically during therapy.
  • Cardiovascular assessment: evaluate for history of arterial events before initiating treatment.
  • Bleeding risk evaluation: avoid use in patients with active bleeding or uncontrolled anticoagulation.
  • Gastrointestinal surveillance: monitor for signs of perforation or severe abdominal pain.
  • Renal function consideration: adjust use in severe renal impairment as advised.
  • Store at below 25°C: keep in the original packaging, protect from moisture and light.

Avoid Interactions

Nintedanib can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: may increase nintedanib exposure and risk of toxicity.
  • Anticoagulants (e.g., warfarin): combined use can heighten bleeding risk.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers: may reduce drug levels and effectiveness.
  • P-glycoprotein substrates: concurrent use may affect plasma concentrations.
  • NSAIDs or antiplatelet agents: increase potential for gastrointestinal bleeding.

Frequently Asked Questions

Nintedanib Onkogen is prescribed for idiopathic pulmonary fibrosis, non‑small cell lung cancer, and selected solid tumours. In each case the drug targets pathways that drive fibrosis or tumour angiogenesis, helping to slow disease progression and improve clinical outcomes when used as part of an appropriate therapeutic regimen.

Nintedanib inhibits the kinase activity of several receptor tyrosine kinases, notably VEGFR, FGFR and PDGFR. By blocking these receptors it reduces endothelial cell proliferation, fibroblast activation and extracellular matrix formation, which together limit abnormal blood‑vessel growth and tissue scarring that characterize the approved disease states.

The specific dose and dosing schedule of Nintedanib Onkogen are determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and other individual factors. Healthcare professionals should follow the latest prescribing information and adjust the regimen as clinically indicated.

Safety data for Nintedanib during pregnancy and lactation are limited. Because potential risks to the fetus or infant cannot be excluded, the drug is generally avoided in pregnant or nursing women unless the potential therapeutic benefit justifies the potential risk. Consultation with a specialist is recommended.

To request Nintedanib Onkogen, submit an enquiry on the product page at gnhindia.com indicating the required quantity. GNH India supplies 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 for idiopathic pulmonary fibrosis is pirfenidone, another antifibrotic agent with a different mechanism of action. While both aim to slow disease progression, Nintedanib targets multiple tyrosine kinases and may have a broader anti‑angiogenic effect, whereas pirfenidone works mainly through anti‑inflammatory pathways. Choice depends on efficacy, tolerability, drug‑interaction profile and individual patient factors.

Nintedanib should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and direct light. Keep the product out of reach of children and avoid exposure to excessive heat or humidity, which could compromise tablet integrity.

Nintedanib is taken orally, usually as a tablet swallowed whole with water. It is typically administered with food to reduce gastrointestinal discomfort, but patients should follow the specific instructions provided by their healthcare professional regarding timing and any dietary considerations.

Serious risks include liver injury (hepatotoxicity), arterial thromboembolic events such as stroke or myocardial infarction, severe bleeding, and gastrointestinal perforation. Patients should be monitored regularly for signs of liver dysfunction, cardiovascular symptoms, unexplained bleeding, or severe abdominal pain, and any concerning findings should prompt immediate medical evaluation.

Nintedanib is contraindicated in patients with known hypersensitivity to the active ingredient or any excipients, in those with active severe bleeding, recent major surgery, or uncontrolled cardiovascular disease. Caution is also advised for individuals with significant hepatic impairment, severe renal dysfunction, or those taking strong CYP3A4 inhibitors without appropriate dose adjustments.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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