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 an oral dosage form for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain cases of non‑small cell lung cancer in adult patients, and is used under specialist supervision.

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

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Nintedanib is used to target fibrotic and oncogenic pathways 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 (selected patients): used in combination therapy to inhibit tumor growth and angiogenesis.

How It Works

  • Nintedanib blocks multiple receptor tyrosine kinases, notably VEGFR‑1/2/3, FGFR‑1/2/3 and PDGFR‑α/β. Inhibition of these pathways reduces endothelial cell proliferation, fibroblast activation and angiogenesis, thereby limiting fibrotic tissue formation and tumor vascularization.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may be transient.
  • Vomiting: occasional episodes.
  • Decreased appetite: reduced desire to eat.
  • Abdominal pain: discomfort in the stomach area.
  • Liver enzyme elevation: mild increase in ALT/AST.

Serious or Rare Side Effects

  • Hepatotoxicity: significant liver injury, may require discontinuation.
  • Bleeding events: increased risk of gastrointestinal or other bleeding.
  • Cardiovascular events: rare cases of hypertension or arterial thromboembolism.
  • Severe infections: opportunistic infections in immunocompromised patients.

Precautions & Warnings

When prescribing Nintedanib, clinicians should consider several safety precautions.

  • Liver function monitoring: assess baseline ALT/AST and repeat periodically.
  • Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea.
  • Drug interactions: review concomitant medications that affect CYP3A4.
  • Pregnancy and lactation: avoid use unless benefits outweigh risks; limited data available.
  • Contraindications: do not use in patients with known hypersensitivity to nintedanib.
  • Store at ambient temperature: keep below 25 °C, retain 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): heightened bleeding risk.
  • Antiplatelet agents (e.g., aspirin, clopidogrel): additive bleeding potential.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampicin): may reduce drug levels.
  • P‑glycoprotein inhibitors (e.g., verapamil): may modestly increase exposure.
  • NSAIDs: may exacerbate gastrointestinal side effects.

Frequently Asked Questions

Nintedanib Stada is prescribed for adult patients with idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for selected cases of non‑small cell lung cancer. In each indication the drug aims to slow disease progression by targeting fibrotic and angiogenic pathways.

Nintedanib inhibits several receptor tyrosine kinases, including VEGFR, FGFR and PDGFR. By blocking these signals it reduces fibroblast proliferation, angiogenesis and the formation of scar tissue, which underlies its antifibrotic and antitumor effects.

The dose of Nintedanib Stada is determined by the prescribing clinician based on the specific indication, patient characteristics and tolerability. The prescribing information provides guidance, but the exact regimen should be individualized and not assumed.

Data on Nintedanib use in pregnancy or lactation are limited. Because potential risks to the fetus or infant cannot be excluded, the drug is generally avoided unless the potential benefit justifies the potential risk. Consultation with a specialist is essential.

To request Nintedanib Stada, 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 fibrotic lung disease is pirfenidone, another antifibrotic agent. While both aim to slow disease progression, Nintedanib targets a broader range of tyrosine kinases, which may provide additional anti‑angiogenic activity in certain cancers. Safety profiles differ, with Nintedanib more frequently causing gastrointestinal upset and liver enzyme changes.

Nintedanib Stada should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Nintedanib is taken orally, usually as a tablet swallowed whole with water. It is generally recommended to take the medication with food to lessen gastrointestinal discomfort, but patients should follow the specific instructions provided by their healthcare professional.

The most serious adverse events include significant liver injury (hepatotoxicity), increased risk of bleeding, and rare severe infections. Patients should be monitored regularly for liver function abnormalities, signs of bleeding, and any unexpected infections, and should report these promptly to their physician.

Nintedanib is contraindicated in individuals with known hypersensitivity to the drug or any of its components. It should also be avoided in patients with severe liver impairment, uncontrolled bleeding disorders, or those who are pregnant unless the potential benefit outweighs the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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