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 tablet for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used in combination therapy for non‑small cell lung cancer.
GNH India supplies Nintedanib Accordpharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Accord Healthcare Polska Sp. Z O.O.

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Indications & Clinical Uses

Nintedanib is indicated for fibrotic lung disorders and as part of combination therapy for certain lung cancers.

  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delay worsening.
  • Non‑small cell lung cancer (in combination therapy): contributes to tumor growth inhibition when used with other agents.

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, angiogenesis, and extracellular matrix deposition, thereby limiting fibrotic remodeling and tumor vascularization.

Side Effects

Nintedanib may cause a range of adverse reactions.

Common Side Effects

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

Serious or Rare Side Effects

  • Elevated liver enzymes (ALT, AST)
  • Bleeding events
  • Cardiovascular complications (e.g., myocardial infarction)
  • Severe infections
  • Gastrointestinal perforation
  • Serious skin reactions (e.g., Stevens‑Johnson syndrome)

Precautions & Warnings

Before initiating therapy, several safety considerations should be reviewed.

  • Dose adjustment in hepatic impairment: reduce dose as recommended.
  • Monitor liver function tests: obtain baseline and periodic assessments.
  • Assess for bleeding risk: avoid concomitant anticoagulants when possible.
  • Pregnancy and breastfeeding: avoid use as safety is unknown.
  • Drug interactions: review concomitant medications for CYP3A4 inhibitors or inducers.
  • Store at below 25°C: keep in the original container, protect from moisture and light.

Avoid Interactions

Nintedanib can interact with several drug classes, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, DOACs): heightened risk of bleeding.
  • Co‑administration with other VEGFR inhibitors: additive toxicity.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampicin): may reduce exposure.
  • P‑gp inhibitors (e.g., verapamil): may increase plasma levels.
  • Diuretics: monitor for dehydration and renal function.

Frequently Asked Questions

Nintedanib Accordpharma is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer. In each case, it aims to slow disease progression by targeting pathways involved in fibrosis and tumor angiogenesis.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR and PDGFR—thereby reducing fibroblast proliferation, new blood‑vessel formation, and extracellular matrix production. This dual antifibrotic and anti‑angiogenic activity helps limit lung scarring and tumor growth.

The specific dose and dosing schedule are determined by the prescribing clinician based on the patient’s condition, renal and hepatic function, and concomitant therapies. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety of Nintedanib in pregnancy and lactation has not been established. It is generally advised to avoid use in pregnant or nursing women unless the potential benefit justifies the potential risk, and this decision should be made by a qualified healthcare professional.

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 needs) and required import documentation.

The primary alternative for idiopathic pulmonary fibrosis is pirfenidone, another antifibrotic agent. While both slow disease progression, Nintedanib targets a broader range of tyrosine kinases, which may provide additional benefit in certain patients, whereas pirfenidone’s safety profile is characterized by different gastrointestinal and skin reactions.

Nintedanib tablets should be stored at temperatures below 25 °C, in their original blister pack, protected from moisture and direct light. Do not store in bathrooms or near heat sources, and keep out of reach of children.

The medication is taken orally as a whole tablet, usually with food to lessen gastrointestinal upset. Patients should swallow the tablet with a full glass of water and avoid crushing or chewing it, unless otherwise directed by a healthcare professional.

Serious adverse events include significant liver enzyme elevations, bleeding complications, cardiovascular events such as myocardial infarction, severe infections, gastrointestinal perforations, and rare but severe skin reactions. Patients should be monitored regularly for these conditions and report any concerning symptoms promptly.

Nintedanib is contraindicated in patients with severe hepatic impairment, known hypersensitivity to the drug, and in pregnant or breastfeeding women. Caution is also advised for individuals with active bleeding disorders, uncontrolled cardiovascular disease, or those taking strong CYP3A4 inhibitors without dose adjustment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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