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

Nintedanib Accordpharma

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Accordpharma (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Accordpharma, is a tyrosine kinase inhibitor presented as an oral formulation for systemic use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain cases of non‑small cell lung cancer in adult patients.

GNH India supplies Nintedanib Accordpharma 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‑approved batches for clinical use under medical supervision.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

Nintedanib is used to treat fibrotic lung diseases and certain cancers by targeting pathways involved in fibroblast activation and tumor angiogenesis.

  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease: improves pulmonary outcomes and stabilizes fibrosis.
  • Non‑small cell lung cancer (in specific settings): inhibits tumor growth and angiogenesis as part of combination therapy.

How It Works

  • Nintedanib inhibits 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 blocking these pathways, it reduces fibroblast proliferation, extracellular matrix deposition, and pathological angiogenesis, thereby attenuating fibrotic remodeling and tumor vascularization.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness or urge to vomit.
  • Abdominal pain: discomfort or cramps in the stomach area.
  • Elevated liver enzymes: increased ALT/AST levels detected in blood tests.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury, potentially leading to jaundice.
  • Bleeding events: gastrointestinal or other bleeding, especially with anticoagulants.
  • Cardiovascular events: arterial thromboembolism or myocardial infarction.

Precautions & Warnings

When prescribing Nintedanib, clinicians should consider several precautionary measures to ensure patient safety.

  • Liver function monitoring: assess ALT/AST before treatment and periodically during therapy.
  • Gastrointestinal management: advise patients on hydration and antidiarrheal measures.
  • Drug interactions: review concomitant use of strong CYP3A4 inhibitors or inducers.
  • Bleeding risk: evaluate history of bleeding disorders or use of anticoagulants.
  • Pregnancy and lactation: avoid use due to unknown safety; discuss contraception.
  • Store at ambient temperature: keep below 25 °C in 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 (e.g., ketoconazole, clarithromycin): may increase plasma levels, raising toxicity risk.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce drug exposure, decreasing effectiveness.
  • P‑glycoprotein substrates (e.g., digoxin): potential for altered concentrations.
  • NSAIDs or aspirin: may exacerbate gastrointestinal bleeding.

Frequently Asked Questions

Nintedanib Accordpharma is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and, in specific clinical settings, for non‑small cell lung cancer. It works by targeting pathways that drive fibrosis and tumor angiogenesis, helping to slow disease progression and improve lung function.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—thereby inhibiting fibroblast proliferation, extracellular matrix formation, and abnormal blood‑vessel growth. This multi‑target inhibition reduces fibrotic tissue development in the lungs and can limit tumor blood supply in certain cancers.

The dosage of Nintedanib Accordpharma is determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and concomitant medications. No fixed regimen is provided here; the prescriber will set the appropriate dose and schedule.

Safety data for Nintedanib during pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It is generally recommended to avoid use in pregnant or nursing women unless the potential benefit justifies the potential risk.

To place an order, 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 the necessary import documentation.

The primary alternative for fibrotic lung disease is pirfenidone, another oral antifibrotic. While both aim to slow disease progression, Nintedanib targets multiple tyrosine kinases, offering broader inhibition of fibroblast activity and angiogenesis, whereas pirfenidone’s mechanism involves modulation of cytokine production and oxidative stress. Choice depends on patient tolerance, comorbidities and physician judgment.

Nintedanib should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and ensure the container is tightly closed when not in use.

Nintedanib is taken orally, usually with food to lessen gastrointestinal discomfort. The tablets are swallowed whole with a full glass of water. Patients should follow the dosing schedule prescribed by their healthcare provider and not alter the timing without medical advice.

Serious risks include hepatotoxicity (significant liver enzyme elevation or liver injury), severe bleeding events (especially when combined with anticoagulants), and cardiovascular complications such as arterial thromboembolism or myocardial infarction. Patients should be monitored regularly for liver function, signs of bleeding, and cardiovascular symptoms.

Nintedanib is contraindicated in patients with known hypersensitivity to the active substance or any of its excipients. It should also be avoided in individuals with severe hepatic impairment, uncontrolled bleeding disorders, or those who are pregnant or breastfeeding without a clear benefit outweighing the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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