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 formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and in combination therapy for non‑small cell lung cancer.
GNH India supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide across multiple regions, ensuring quality and regulatory compliance.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Nintedanib is used to target fibrotic lung disease pathways and certain oncologic indications.

  • 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): enhances treatment efficacy when combined with chemotherapy.

How It Works

  • Nintedanib competitively inhibits multiple receptor tyrosine kinases, including VEGFR 1‑3, PDGFR‑α/β and FGFR 1‑3. Blocking these receptors curtails fibroblast proliferation, extracellular matrix deposition, and angiogenesis by dampening downstream MAPK and PI3K/AKT signaling pathways, thereby reducing fibrotic tissue formation and tumor vascular support.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent loose stools, often mild to moderate.
  • Nausea: feeling of sickness, may be transient.
  • Decreased appetite: reduced desire to eat.
  • Liver enzyme elevation: mild increase in ALT/AST.

Serious or Rare Side Effects

  • Severe liver injury: marked transaminase rise or hepatitis.
  • Gastrointestinal perforation: rare but serious.
  • Hemorrhage: increased risk of bleeding.

Precautions & Warnings

When prescribing Nintedanib Stada, clinicians should consider several safety measures.

  • Monitor liver function: perform baseline and periodic ALT/AST tests.
  • Assess for gastrointestinal disorders: evaluate history of ulcer or perforation.
  • Evaluate bleeding risk: caution in patients on anticoagulants.
  • Pregnancy and lactation: avoid use as safety is unknown.
  • Dose adjustments: consider renal or hepatic impairment per prescriber guidance.
  • Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.

Avoid Interactions

Nintedanib Stada interacts with several drug classes that may require avoidance or close monitoring.

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 levels.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Antiplatelet agents (e.g., aspirin, clopidogrel): monitor for bleeding.
  • NSAIDs: increase gastrointestinal adverse events.

Frequently Asked Questions

Nintedanib Stada contains the active substance nintedanib, a tyrosine kinase inhibitor indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer. It works by targeting pathways that drive fibrosis and tumor angiogenesis, helping to slow disease progression in these conditions.

Nintedanib blocks several receptor tyrosine kinases, including VEGFR 1‑3, PDGFR‑α/β and FGFR 1‑3. Inhibiting these receptors reduces fibroblast proliferation, extracellular matrix deposition, and new blood‑vessel formation. The resulting decrease in fibrotic tissue development and tumor vascular support underlies its therapeutic effects in pulmonary fibrosis and certain cancers.

The specific dose and dosing schedule of Nintedanib Stada are determined by the prescribing physician based on the patient’s condition, weight, renal and hepatic function, and concomitant therapies. Healthcare professionals follow the approved labeling and clinical guidelines to select an appropriate regimen for each individual.

The safety of nintedanib in pregnancy and lactation has not been established. It is classified as contraindicated or not recommended for use in pregnant or nursing women because potential risks to the fetus or infant cannot be ruled out. Women of child‑bearing potential should use effective contraception during treatment and discuss alternatives with their doctor.

To request Nintedanib Stada, visit the product page on gnhindia.com and submit an enquiry with 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 necessary import documentation.

The primary alternative for antifibrotic therapy in idiopathic pulmonary fibrosis is pirfenidone. Both agents slow disease progression, but nintedanib targets multiple tyrosine kinases, whereas pirfenidone’s mechanism involves modulation of cytokine production and oxidative stress. Choice between them depends on patient tolerance, comorbidities, drug‑interaction profile and physician judgment.

Nintedanib Stada should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original container, protect it from moisture and direct sunlight, and avoid exposure to extreme temperatures. Do not refrigerate or freeze unless specifically instructed by the manufacturer.

Nintedanib Stada is taken orally, usually with food to lessen gastrointestinal discomfort. The tablets (or capsules, depending on the marketed form) are swallowed whole with a glass of water. Patients should follow the prescriber’s instructions regarding timing, dose adjustments and any required monitoring.

The most serious adverse events reported with nintedanib include severe liver injury, gastrointestinal perforation and significant bleeding. Patients should be monitored for signs of hepatic dysfunction, abdominal pain suggestive of perforation, and unusual bruising or hemorrhage. Prompt medical evaluation is essential if any of these symptoms arise.

Nintedanib Stada is contraindicated in patients with known hypersensitivity to nintedanib or any excipients, in those with active severe hepatic impairment, and in individuals with a history of gastrointestinal perforation. Caution is also advised for patients on strong anticoagulants or with uncontrolled bleeding disorders. The prescriber must assess each patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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