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 dosage form for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in appropriate patients.

GNH India supplies Nintedanib Accordpharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, transplant 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 diseases and certain cancers, acting on pathways that drive fibroblast activity and tumor growth.

  • Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function.
  • Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity.
  • Non‑small cell lung cancer (in combination therapy): improves progression‑free survival in eligible patients.

How It Works

  • Nintedanib competitively and reversibly inhibits multiple receptor tyrosine kinases, including VEGFR 1‑3, PDGFR‑α/β and FGFR 1‑3. Blocking these receptors curtails endothelial cell proliferation, fibroblast activation and angiogenesis, thereby limiting fibrotic tissue formation and tumor vascularisation through downstream MAPK and PI3K pathway suppression.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent, may be mild to moderate.
  • Nausea: occasional, often transient.
  • Vomiting: occasional.
  • Elevated liver enzymes (ALT/AST): observed in routine monitoring.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury, requires monitoring.
  • Bleeding events: increased risk of gastrointestinal or pulmonary hemorrhage.
  • Cardiovascular events: arterial thrombotic events such as myocardial infarction.

Precautions & Warnings

When prescribing Nintedanib, clinicians should consider several safety measures.

  • Liver function monitoring: assess ALT, AST and bilirubin before and during therapy.
  • Gastrointestinal management: treat diarrhea promptly to avoid dehydration.
  • Cardiovascular assessment: evaluate history of arterial thrombotic disease before initiating.
  • Drug interactions: review concomitant medications that affect CYP3A4.
  • Pregnancy and lactation: avoid use; safety not established.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and light.

Avoid Interactions

Nintedanib interacts with several drug classes; awareness helps minimise risk.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): increased bleeding risk.
  • Potent CYP3A4 inhibitors (e.g., ketoconazole): may raise exposure, caution advised.

Moderate Interactions (Monitor Closely)

  • P‑glycoprotein inhibitors (e.g., verapamil): may increase plasma levels.
  • NSAIDs or aspirin: additive risk of gastrointestinal bleeding.
  • Diuretics: monitor for dehydration if severe diarrhea occurs.

Frequently Asked Questions

Nintedanib Accordpharma is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and, in combination with other agents, for certain cases of non‑small cell lung cancer. It targets the underlying fibrotic and angiogenic processes that drive disease progression.

Nintedanib blocks multiple receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby inhibiting signalling pathways that promote fibroblast proliferation, angiogenesis and extracellular matrix deposition. This dual antifibrotic and anti‑angiogenic activity helps slow tissue scarring and tumor growth.

The specific dose and dosing schedule of Nintedanib Accordpharma are determined by the treating physician 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 during pregnancy or 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 a healthcare professional should be consulted.

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 and any necessary import documentation.

The primary alternative for idiopathic pulmonary fibrosis is pirfenidone, another antifibrotic agent. While both aim to slow disease progression, Nintedanib targets a broader range of tyrosine kinases, potentially offering benefits in patients with concomitant vascular involvement, whereas pirfenidone’s mechanism focuses on oxidative stress and cytokine modulation.

Nintedanib should be stored at ambient temperature, preferably below 25 °C, in its original container to protect it from moisture and light. Keep the product out of reach of children and avoid storing in areas with high humidity or direct sunlight.

Nintedanib is taken orally, usually with food to lessen gastrointestinal discomfort. Tablets are swallowed whole with a glass of water and should be taken at the same time each day as directed by the prescriber.

Serious risks include liver injury (elevated transaminases or hepatitis), severe bleeding events, and arterial thrombotic complications such as myocardial infarction. Patients should report signs of jaundice, unusual bruising, or chest pain to their healthcare provider promptly.

Nintedanib is contraindicated in patients with known hypersensitivity to the drug, those with severe hepatic impairment, and individuals taking strong CYP3A4 inducers that could markedly reduce its efficacy. Caution is also advised for patients with active bleeding disorders or uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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