Product image of Nintedanib supplied by GNH India

Nintedanib

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib

Nintedanib, the active ingredient in Nintedanib, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used with docetaxel for non‑small cell lung cancer. The drug is marketed in the European Union and is supplied under strict regulatory standards.

GNH India supplies Nintedanib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Reddy Holding Gmbh

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Indications & Clinical Uses

  • Nintedanib acts on fibrotic and oncologic pathways, providing therapeutic benefit in several serious lung conditions.
  • 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 with docetaxel): improves overall survival when added to chemotherapy.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases—including vascular endothelial growth factor receptors (VEGFR 1‑3), platelet‑derived growth factor receptors (PDGFR‑α/β), and fibroblast growth factor receptors (FGFR 1‑3). By blocking these pathways, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby attenuating fibrotic remodeling and tumor‑related vascular growth.

Side Effects

Nintedanib may cause a range of adverse reactions, from mild to serious. Patients should be informed of common and less frequent events.

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: sensation of unease or urge to vomit.
  • Decreased appetite: reduced desire to eat.
  • Elevated liver enzymes: mild transaminase increases.

Serious or Rare Side Effects

  • Hepatic failure: severe liver injury requiring monitoring.
  • Major bleeding: gastrointestinal or intracranial hemorrhage.
  • Cardiovascular events: myocardial infarction or ischemic heart disease.
  • Gastrointestinal perforation: rare but potentially life‑threatening.
  • Severe infections: opportunistic or bacterial infections.
  • Pneumothorax: collapsed lung, especially in advanced lung disease.

Precautions & Warnings

  • Before initiating therapy, clinicians should consider several safety measures.
  • Monitor liver function: baseline and periodic tests due to risk of hepatotoxicity.
  • Assess bleeding risk: avoid in patients with active hemorrhage or uncontrolled anticoagulation.
  • Evaluate cardiovascular status: use cautiously in patients with ischemic heart disease.
  • Pregnancy and breastfeeding: use only if benefits outweigh potential risks; data are limited.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Nintedanib can interact with other medicines, affecting its safety and efficacy.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: may increase nintedanib exposure and toxicity.
  • Anticoagulants: additive risk of serious bleeding.
  • High‑dose aspirin: heightened gastrointestinal adverse effects.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers: may reduce therapeutic effect.
  • P‑glycoprotein inhibitors: could raise plasma concentrations.
  • Diuretics: monitor for dehydration and renal function changes.

Frequently Asked Questions

Nintedanib is approved for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for use in combination with docetaxel in patients with non‑small cell lung cancer. In each case the drug aims to slow disease progression and improve clinical outcomes.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby inhibiting fibroblast growth, angiogenesis and the deposition of scar tissue. This multi‑targeted inhibition reduces fibrotic remodeling in the lungs and can also limit tumor‑related vascular growth.

The prescribed dose of Nintedanib is determined by the treating physician based on the specific indication, patient characteristics and any concomitant therapies. Dosing recommendations are provided in the product’s prescribing information and should be followed exactly as directed.

Safety data for Nintedanib in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment and for a defined period after discontinuation.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and import documentation.

Compared with other antifibrotics such as pirfenidone, Nintedanib has a broader kinase inhibition profile, targeting VEGFR, PDGFR and FGFR. Clinical trials show similar efficacy in slowing lung function decline, but the safety and tolerability profiles differ, with Nintedanib more commonly associated with gastrointestinal side effects.

Nintedanib tablets should be stored at ambient temperature below 25 °C, in the original packaging, and protected from moisture and direct sunlight. Do not store in bathrooms or near heat sources to maintain product stability.

Nintedanib is taken orally as a tablet, usually with food to reduce gastrointestinal discomfort. The tablet should be swallowed whole with water and not chewed, crushed or split unless specifically instructed by a healthcare professional.

Serious risks include liver injury, severe bleeding, cardiovascular events such as myocardial infarction, gastrointestinal perforation, and rare but life‑threatening infections. Patients should be monitored regularly for signs of these events, and therapy should be discontinued if severe toxicity occurs.

Nintedanib is contraindicated in patients with known hypersensitivity to the drug or any of its excipients, in those with active bleeding disorders, and in individuals with severe hepatic impairment. Caution is also advised for patients with uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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