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 formulation 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 as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Laboratorio Stada, S.L.

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Indications & Clinical Uses

  • Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncogenic pathways.
  • 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: used in combination therapy to inhibit tumor growth.

How It Works

  • Nintedanib inhibits several 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 limiting fibrotic remodeling and tumor angiogenesis.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: sensation of unease and urge to vomit.
  • Vomiting: expulsion of stomach contents.
  • Abdominal pain: discomfort in the stomach area.
  • Decreased appetite: reduced desire to eat.
  • Weight loss: unintended reduction in body weight.

Serious or Rare Side Effects

  • Elevated liver enzymes: indicates possible liver injury.
  • Bleeding events: includes gastrointestinal or pulmonary hemorrhage.
  • Cardiovascular events: such as myocardial infarction or stroke.
  • Severe infections: opportunistic or bacterial infections.
  • Gastrointestinal perforation: rare but potentially life‑threatening.

Precautions & Warnings

  • Before initiating therapy, clinicians should assess patient‑specific risk factors and monitor for adverse events.
  • Monitor liver function: perform baseline and periodic liver enzyme tests.
  • Assess bleeding risk: evaluate concomitant anticoagulant use and history of hemorrhage.
  • Evaluate cardiovascular status: watch for signs of ischemic events.
  • Avoid use in pregnancy: teratogenic potential is unknown; contraindicated.
  • Adjust for hepatic impairment: dose may need modification in moderate to severe liver disease.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Nintedanib can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
  • P‑glycoprotein inhibitors (e.g., verapamil): can raise plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise levels.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • NSAIDs or antiplatelet agents: monitor for additive bleeding.
  • St. John’s wort: potential reduction in drug exposure.
  • Proton pump inhibitors: may affect absorption, observe clinical response.

Frequently Asked Questions

Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for use in combination therapy for non‑small cell lung cancer. In each case, it targets pathways that drive fibrosis or tumor growth, helping to slow disease progression.

Nintedanib blocks multiple receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby reducing fibroblast activation, angiogenesis, and extracellular matrix formation. This inhibition limits fibrotic tissue remodeling in the lungs and can also impede tumor blood vessel formation in cancer.

The specific dose and dosing schedule of Nintedanib are determined by the prescribing clinician based on the patient’s condition, weight, liver function and other factors. Patients should follow the exact regimen provided by their healthcare professional.

The 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 physician.

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 and any necessary import documentation.

Compared with other antifibrotics such as pirfenidone, Nintedanib targets a broader range of tyrosine kinases, offering a distinct mechanism that may be advantageous in certain patients. Choice of therapy depends on efficacy, tolerability, drug‑drug interactions and individual patient factors.

Nintedanib should be stored at room temperature, below 25 °C, in its original packaging. Keep the product away from moisture and direct sunlight to maintain stability throughout its shelf life.

Nintedanib is taken orally, usually as a tablet, with food to reduce gastrointestinal discomfort. The exact timing and whether it should be taken with a meal are determined by the prescribing clinician.

Serious risks include liver enzyme elevations indicating possible hepatic injury, significant bleeding events, cardiovascular complications such as myocardial infarction, and rare cases of gastrointestinal perforation. Patients should be monitored regularly for these adverse outcomes.

Nintedanib is contraindicated in patients with known hypersensitivity to the drug, those with severe liver impairment, and in pregnant women unless absolutely necessary. Caution is also advised for individuals with a high bleeding risk or uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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