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 an oral tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in adult patients. It is administered orally and works by targeting multiple growth factor receptors involved in fibrotic processes.

GNH India supplies Nintedanib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, providing reliable access to this antifibrotic therapy for patients in need.

Manufacturer / TM Owner

Eugia Pharma (Malta) Ltd

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Indications & Clinical Uses

  • Nintedanib is used to address fibrotic and oncologic conditions by inhibiting key pathways involved in disease progression.
  • Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
  • Systemic sclerosis‑associated interstitial lung disease: improves lung capacity and delays worsening of fibrosis.
  • Non‑small cell lung cancer: used in combination therapy to inhibit tumor angiogenesis and growth.

How It Works

  • Nintedanib blocks the intracellular kinase activity of several 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 preventing ligand‑induced activation of these receptors, the drug reduces endothelial cell proliferation, fibroblast activation, and angiogenic signaling, thereby limiting fibrotic tissue formation and tumor vascularization.

Side Effects

Nintedanib may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Diarrhea: frequent loose stools.
  • Nausea: feeling sick.
  • Decreased appetite: reduced desire to eat.
  • Liver enzyme elevation: mild increase in ALT/AST.

Serious or Rare Side Effects

  • Severe liver injury: marked enzyme rise or hepatitis.
  • Cardiovascular events: arterial thromboembolism or myocardial infarction.
  • Gastrointestinal perforation: rare tearing of the intestinal wall.

Precautions & Warnings

When prescribing Nintedanib, clinicians should consider several safety measures to minimize risk.

  • Monitor liver function: perform baseline and periodic ALT/AST testing.
  • Assess bleeding risk: avoid in patients with active hemorrhage or on anticoagulants.
  • Evaluate cardiovascular status: caution in patients with history of arterial thromboembolism.
  • Watch for gastrointestinal symptoms: manage diarrhea and nausea promptly.
  • Pregnancy and lactation: contraindicated or use only if benefits outweigh risks (category unknown).
  • Store at ambient temperature: keep below 25°C in original packaging, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise drug levels.
  • P-glycoprotein substrates (e.g., digoxin): potential altered absorption.
  • CYP3A4 inducers (e.g., rifampicin): may reduce Nintedanib effectiveness.

Frequently Asked Questions

Nintedanib is prescribed for adult patients with idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for use in combination regimens for non‑small cell lung cancer. In each case it aims to slow disease progression by targeting pathways that drive fibrosis or tumor angiogenesis.

Nintedanib inhibits multiple receptor tyrosine kinases—VEGFR, FGFR and PDGFR—by blocking their intracellular kinase activity. This prevents downstream signaling that promotes fibroblast proliferation, extracellular matrix deposition, and new blood‑vessel formation, thereby reducing fibrotic tissue and tumor vascular support.

The exact dose of Nintedanib is determined by the prescribing physician based on the specific indication, patient characteristics and any concomitant therapies. Dosing recommendations are provided in the product label and should be followed as directed by a qualified healthcare professional.

The safety of Nintedanib during pregnancy and lactation has not been established. It is classified as unknown for pregnancy, and the drug should only be used if the potential benefit justifies the potential risk to the fetus. Breastfeeding is not recommended while taking Nintedanib.

To request Nintedanib, 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 import documentation.

For idiopathic pulmonary fibrosis, the primary alternative is pirfenidone, another antifibrotic agent. Nintedanib targets a broader range of tyrosine kinases, offering a different safety profile and may be preferred in patients who cannot tolerate pirfenidone’s gastrointestinal side effects. Choice between agents depends on individual patient factors and physician judgment.

Nintedanib tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack to protect them from moisture and light. Keep the container tightly closed and out of reach of children. Do not store in bathrooms or other humid environments.

Nintedanib is taken orally as a tablet, usually with a full glass of water. It can be taken with or without food, but patients are advised to follow any specific instructions from their prescriber. Swallow the tablet whole; do not crush, split, or chew it unless directed otherwise.

The most serious adverse events include severe liver injury (marked elevation of liver enzymes or hepatitis), cardiovascular complications such as arterial thromboembolism or myocardial infarction, and rare gastrointestinal perforation. Patients should report any signs of jaundice, chest pain, sudden abdominal pain, or unusual bleeding promptly.

Nintedanib is contraindicated in patients with known hypersensitivity to the active substance or any of its excipients. It should be avoided in individuals with active bleeding, uncontrolled hypertension, severe hepatic impairment, or those receiving strong CYP3A4 inhibitors without dose adjustment. Pregnant or breastfeeding women should also refrain from use unless absolutely necessary.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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