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 formulation for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer when used with docetaxel.
GNH India supplies Nintedanib Clonmel as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Clonmel Healthcare Ltd.

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Indications & Clinical Uses

Nintedanib acts on multiple fibrotic and oncogenic pathways, providing therapeutic benefit in several serious lung conditions.

  • Idiopathic pulmonary fibrosis (IPF): slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease (SSc‑ILD): helps preserve lung capacity and delays worsening.
  • Non‑small cell lung cancer (NSCLC) in combination with docetaxel: improves overall survival and response rates.

How It Works

  • Nintedanib inhibits a spectrum of receptor tyrosine kinases—including VEGFR, FGFR, and PDGFR—as well as non‑receptor kinases. By blocking these signaling pathways, it reduces fibroblast proliferation, migration, and transformation, and also exerts anti‑angiogenic effects that limit tumor vascularisation and growth.

Side Effects

Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea and vomiting: gastrointestinal upset that may affect appetite.
  • Abdominal pain: discomfort in the stomach region.
  • Decreased appetite: reduced desire to eat.
  • Elevated liver enzymes: mild increases in ALT/AST.
  • Headache: occasional mild to moderate pain.

Serious or Rare Side Effects

  • Severe liver injury: jaundice, hepatitis, or hepatic failure.
  • Arterial thromboembolism: risk of blood clots in arteries.
  • Major bleeding: gastrointestinal or intracranial hemorrhage.
  • Gastrointestinal perforation: rare but serious ulceration.
  • Severe infections: opportunistic infections in immunocompromised patients.
  • Lung hemorrhage: rare bleeding within lung tissue.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient-specific risk factors and monitor key parameters.

  • Monitor liver function: obtain baseline and periodic ALT/AST measurements.
  • Assess cardiovascular risk: screen for history of arterial thrombosis.
  • Watch for gastrointestinal bleeding: especially if patient uses anticoagulants or antiplatelet agents.
  • Avoid use in severe hepatic impairment: contraindicated in patients with Child‑Pugh C liver disease.
  • Store at below 25°C: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): increase nintedanib exposure and toxicity.
  • Anticoagulants (e.g., warfarin): heighten risk of serious bleeding.
  • P‑glycoprotein inhibitors (e.g., itraconazole): raise plasma concentrations.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin): reduce nintedanib effectiveness.
  • Antiplatelet agents (e.g., aspirin): additive bleeding risk.
  • Diuretics: may exacerbate dehydration from diarrhea, requiring fluid monitoring.

Frequently Asked Questions

Nintedanib Clonmel is indicated for idiopathic pulmonary fibrosis (IPF), systemic sclerosis‑associated interstitial lung disease (SSc‑ILD), and for non‑small cell lung cancer (NSCLC) when given together with docetaxel. In each case the drug targets pathways that drive fibrosis or tumor angiogenesis, helping to slow disease progression.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR, and PDGFR—as well as non‑receptor kinases. By inhibiting these signals, it reduces fibroblast activity and angiogenesis, which are key processes in lung fibrosis and tumor growth. This multi‑target approach limits tissue scarring and tumor blood‑supply formation.

The prescribed dose of Nintedanib Clonmel is determined by the treating physician based on the specific indication, patient characteristics, and clinical guidelines. Healthcare professionals adjust the regimen to balance efficacy with tolerability, and patients should follow the exact dosing instructions provided by their prescriber.

Safety data for Nintedanib in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It is generally advised to avoid use during pregnancy and breastfeeding unless the potential benefit justifies the potential risk, and this decision should be made by a qualified healthcare professional.

To request Nintedanib Clonmel, 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 needs), and required import documentation.

The primary alternative for fibrotic lung disease is pirfenidone, another antifibrotic agent. While both slow disease progression, Nintedanib targets a broader range of tyrosine kinases, offering additional anti‑angiogenic activity, which can be advantageous in certain cancer settings. Choice between them depends on patient tolerance, comorbidities, and physician assessment.

Nintedanib Clonmel should be stored at temperatures below 25 °C, in its original packaging, and protected from moisture and direct sunlight. Maintaining these conditions helps preserve the drug’s stability and potency throughout its shelf life.

Nintedanib is taken orally, usually with food to lessen gastrointestinal upset. The tablets (or capsules, depending on the marketed form) are swallowed whole with a full glass of water. Patients should follow the exact schedule prescribed by their healthcare provider and not alter the dosing without medical advice.

Serious risks include severe liver injury, arterial thromboembolic events, major bleeding, gastrointestinal perforation, and rare lung hemorrhage. Patients should be monitored regularly for signs of hepatic dysfunction, cardiovascular events, and any unexpected bleeding, and they should report such symptoms promptly to their clinician.

Nintedanib is contraindicated in patients with severe hepatic impairment (Child‑Pugh C) and in those with known hypersensitivity to the drug or any of its excipients. Caution is also advised for individuals with a history of arterial thrombosis, uncontrolled bleeding disorders, or significant gastrointestinal disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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