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

Nintedanib Stada

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Stada (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Stada, is a tyrosine kinase inhibitor presented as a tablet 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 Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Stada Lda.

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Indications & Clinical Uses

Nintedanib is used to treat fibrotic lung conditions and certain cancers by targeting pathways that drive fibroblast proliferation and angiogenesis.

  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening.
  • Non‑small cell lung cancer (in combination therapy): inhibits tumor growth and angiogenesis.

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 angiogenesis, fibroblast activation, and extracellular matrix deposition, thereby limiting fibrosis and tumor vascularization.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may affect appetite.
  • Vomiting: occasional episodes, usually self‑limiting.
  • Elevated liver enzymes: increased ALT/AST levels detected in blood tests.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury, jaundice, or hepatitis.
  • Bleeding events: gastrointestinal or pulmonary hemorrhage.
  • Cardiovascular events: arterial thromboembolism or myocardial infarction.

Precautions & Warnings

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

  • Liver function monitoring: assess baseline ALT/AST and repeat regularly.
  • Gastrointestinal assessment: evaluate history of severe diarrhea or ulcerative colitis.
  • Cardiovascular risk: review for recent arterial thrombotic events.
  • Drug interactions: avoid concurrent use with strong CYP3A4 inhibitors.
  • Pregnancy and breastfeeding: use only if clearly needed; safety not established.
  • Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.

Avoid Interactions

Nintedanib can interact with other medicines, affecting its concentration or increasing toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise levels.
  • P‑glycoprotein substrates (e.g., digoxin): potential altered plasma concentrations.
  • CYP1A2 inducers (e.g., smoking): may reduce efficacy.

Frequently Asked Questions

Nintedanib Stada 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 indication, the drug aims to slow disease progression by targeting pathways that promote fibrosis and abnormal blood vessel formation.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR. Inhibiting these receptors reduces angiogenesis, fibroblast proliferation, and extracellular matrix production, which together help limit fibrotic tissue formation and tumor vascularization.

The prescribed dose of Nintedanib is determined by the treating physician based on the specific indication, patient characteristics, and tolerability. Clinicians follow approved labeling and adjust the regimen as needed, but exact dosing details should always be obtained from the prescriber.

Safety data for Nintedanib during pregnancy and lactation are limited. It should only be used when the potential benefit justifies any potential risk to the fetus or infant, and the decision must 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 aim to slow lung function decline, Nintedanib targets multiple tyrosine kinases, offering broader inhibition of angiogenic and fibrotic pathways, whereas pirfenidone works mainly through anti‑inflammatory and antioxidant mechanisms. Choice depends on patient tolerance, comorbidities and physician judgment.

Nintedanib Stada tablets should be stored at ambient temperature, preferably below 25 °C. Keep the medication in its original container, protect it from moisture and direct sunlight, and ensure the package remains tightly closed until use.

Nintedanib is taken orally, usually with food to lessen gastrointestinal discomfort. The 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 hepatotoxicity (significant liver enzyme elevation or liver failure), severe bleeding events such as gastrointestinal or pulmonary hemorrhage, and cardiovascular complications like arterial thromboembolism or myocardial infarction. Patients should be monitored regularly for these events.

Nintedanib is contraindicated in patients with known hypersensitivity to the drug, those with active severe liver disease, uncontrolled bleeding disorders, or recent arterial thrombotic events. Caution is also advised for individuals on strong CYP3A4 inhibitors or anticoagulant therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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