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

Nintedanib Clonmel

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Clonmel (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Clonmel, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in appropriately selected patients.

GNH India supplies Nintedanib Clonmel as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. Our distribution network complies with EU regulations and ensures product integrity through validated cold‑chain logistics where required.

Manufacturer / TM Owner

Clonmel Healthcare Ltd.

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Indications & Clinical Uses

Nintedanib is employed in fibrotic lung disorders and selected oncology settings, targeting pathways that drive fibroblast proliferation and tumor angiogenesis.

  • Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
  • Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and stabilises respiratory status.
  • Non‑small cell lung cancer: used in combination therapy to inhibit tumor angiogenesis and proliferation.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases—including VEGFR, FGFR and PDGFR—thereby blocking downstream signalling that promotes fibroblast proliferation, angiogenesis and extracellular matrix deposition. This multi‑target inhibition reduces fibrotic remodeling in the lung and limits tumour‑driven vascular growth in cancer.

Side Effects

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

Common Side Effects

  • Nausea
  • Diarrhoea
  • Vomiting
  • Decreased appetite
  • Abdominal pain
  • Weight loss

Serious or Rare Side Effects

  • Elevated liver enzymes (ALT/AST)
  • Severe bleeding events
  • Cardiovascular complications (e.g., myocardial infarction)
  • Gastrointestinal perforation
  • Pulmonary embolism
  • Severe infections

Precautions & Warnings

Before initiating therapy, clinicians should assess organ function and potential risk factors.

  • Liver monitoring: perform baseline and periodic liver function tests.
  • Cardiovascular assessment: evaluate history of heart disease or thromboembolic events.
  • Bleeding risk: use caution in patients receiving anticoagulants or antiplatelet agents.
  • Pregnancy: avoid use; safety in pregnancy and lactation is unknown.
  • Hepatic impairment: dose adjustment may be required in moderate to severe liver dysfunction.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Nintedanib can interact with several drug classes, necessitating careful review of concomitant medications.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole).
  • Anticoagulants (e.g., warfarin) – increased bleeding risk.
  • Antiplatelet agents (e.g., aspirin, clopidogrel) – heightened hemorrhage.
  • P‑gp inhibitors (e.g., verapamil) – elevated plasma levels.
  • CYP2C8 inhibitors (e.g., gemfibrozil) – increased exposure.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin) – reduced efficacy.
  • Moderate CYP2C8 inhibitors (e.g., trimethoprim).
  • Non‑steroidal anti‑inflammatory drugs – additive gastrointestinal toxicity.
  • Statins metabolised by CYP3A4 (e.g., simvastatin) – risk of myopathy.
  • Diuretics – monitor electrolytes and renal function.

Frequently Asked Questions

Nintedanib Clonmel is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for certain cases of non‑small cell lung cancer. In each indication the drug aims to slow disease progression by inhibiting pathways that drive fibrosis or tumor angiogenesis.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—preventing downstream signalling that leads to fibroblast proliferation, new blood‑vessel formation and extracellular‑matrix deposition. This multi‑target inhibition reduces fibrotic tissue remodeling and limits tumour‑related vascular growth.

The specific dose and dosing schedule for Nintedanib Clonmel are determined by the prescribing clinician based on the patient’s condition, weight, organ function and other individual factors. No fixed regimen is provided here; the prescriber will set the appropriate regimen.

Safety data for nintedanib in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It is generally avoided in pregnant or nursing women unless the potential benefit outweighs the potential risk, and a healthcare professional should be consulted.

To request Nintedanib Clonmel, submit an enquiry on the product page at gnhindia.com indicating 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 needs) and required import documentation.

The primary alternative for IPF is pirfenidone, another antifibrotic agent. While both drugs aim to slow disease progression, nintedanib targets multiple tyrosine kinases, whereas pirfenidone’s mechanism involves inhibition of transforming growth factor‑β signalling. Choice between them depends on efficacy, tolerability, patient comorbidities and physician preference.

Nintedanib Clonmel should be stored at temperatures below 25 °C, in its original packaging, and protected from moisture and direct sunlight. Keeping the product in a dry, cool place helps maintain its stability and potency throughout its shelf life.

The medication is taken orally, usually as a tablet, with or without food as directed by the prescriber. Patients should swallow the tablet whole with water and follow any specific instructions regarding timing or dose adjustments provided by their healthcare professional.

Serious adverse events include significant liver enzyme elevations, severe bleeding, cardiovascular complications such as myocardial infarction, gastrointestinal perforation, and rare cases of pulmonary embolism. Patients should be monitored regularly for these events, and therapy should be discontinued if any serious reaction occurs.

Patients with known hypersensitivity to nintedanib or any excipients, those with severe hepatic impairment, uncontrolled cardiovascular disease, active bleeding disorders, or who are pregnant or breastfeeding without a clear benefit‑risk justification should avoid using Nintedanib Clonmel.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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