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 treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used 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 and pharmacies worldwide.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Nintedanib Stada 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 delays worsening.
  • Non‑small cell lung cancer (in combination therapy): contributes to tumor growth inhibition when used with other anticancer agents.

How It Works

  • Nintedanib inhibits 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 blocking these pathways, it reduces fibroblast proliferation, migration, and transformation, and exerts anti‑angiogenic effects that limit fibrotic tissue formation and tumor vascularisation.

Side Effects

Nintedanib may cause a range of adverse reactions.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Diarrhea: frequent loose stools, often manageable with hydration.
  • Vomiting: occasional episodes, especially early in therapy.
  • Decreased appetite: reduced desire to eat, may lead to weight loss.
  • Abdominal pain: cramping or discomfort in the stomach area.
  • Elevated liver enzymes: laboratory indication of hepatic stress.

Serious or Rare Side Effects

  • Hepatic failure: signs include jaundice, dark urine, or severe fatigue.
  • Severe bleeding: gastrointestinal or intracranial hemorrhage requiring medical attention.
  • Arterial thromboembolism: sudden chest pain, limb ischemia, or stroke symptoms.
  • Severe hypertension: markedly high blood pressure needing urgent control.
  • Gastrointestinal perforation: sudden severe abdominal pain, fever, and peritonitis.

Precautions & Warnings

Before initiating therapy, clinicians should assess baseline organ function and comorbidities.

  • Liver monitoring: perform baseline and periodic liver function tests.
  • Cardiovascular assessment: evaluate history of hypertension, ischemic disease, or thromboembolic events.
  • Bleeding risk: review concomitant anticoagulant or antiplatelet use.
  • Gastrointestinal health: caution in patients with ulcer disease or recent surgery.
  • Pregnancy and lactation: avoid use unless benefits outweigh potential risks.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
  • Antiplatelet agents (e.g., clopidogrel, high‑dose aspirin): additive hemorrhagic potential.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Calcium channel blockers (e.g., amlodipine, nifedipine): may increase plasma levels modestly.
  • Statins metabolised by CYP3A4 (e.g., simvastatin, atorvastatin): monitor for muscle toxicity.

Frequently Asked Questions

Nintedanib Stada is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer. In each case, the drug targets pathways that drive fibrosis or tumor angiogenesis, helping to slow disease progression and improve clinical outcomes when used under specialist supervision.

Nintedanib blocks multiple receptor tyrosine kinases, including VEGFR, FGFR and PDGFR. By inhibiting these receptors, it reduces fibroblast activation and migration, limits new blood‑vessel formation, and curtails the signalling that fuels fibrotic tissue and tumor growth. This multi‑targeted approach underlies its antifibrotic and anti‑angiogenic effects.

The specific dose and dosing schedule of Nintedanib Stada are determined by the prescribing clinician based on the patient’s indication, renal and hepatic function, and overall health status. Healthcare professionals follow the approved labeling and adjust the regimen as needed; patients should follow the exact instructions provided by their prescriber.

Safety data for Nintedanib Stada in pregnancy and lactation are limited, and the drug is generally avoided unless the potential benefit justifies the potential risk to the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment, and breastfeeding mothers should discuss alternatives with their healthcare provider.

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 (including any cold‑chain requirements) and the necessary import documentation.

The primary alternative for IPF is pirfenidone, another antifibrotic agent. While both drugs aim to slow lung function decline, Nintedanib targets a broader range of tyrosine kinases, potentially offering benefit in patients with concomitant vascular involvement. Pirfenidone works mainly through anti‑inflammatory and antioxidant pathways. Choice of therapy depends on individual tolerability, comorbidities and physician judgment.

Nintedanib Stada should be stored at temperatures below 25 °C, in its original packaging to protect it from moisture and light. Keep the product in a dry place away from direct heat sources. Do not refrigerate or freeze the tablets, and ensure the container is tightly closed when not in use.

Nintedanib Stada is taken orally, usually with food to lessen gastrointestinal discomfort. The tablets are swallowed whole with a full glass of water and should be taken at the same time each day to maintain consistent blood levels. Patients must follow the dosing schedule prescribed by their healthcare professional.

The most serious adverse events include severe liver injury (signs such as jaundice or dark urine), major bleeding episodes (e.g., gastrointestinal or intracranial hemorrhage), arterial thromboembolic events (such as stroke or heart attack), and significant hypertension. Patients should seek immediate medical attention if they notice any of these symptoms.

Nintedanib Stada is contraindicated in patients with severe hepatic impairment, those who are pregnant or breastfeeding without a clear benefit, and individuals with a known hypersensitivity to nintedanib or any of the tablet excipients. Caution is also advised for patients with uncontrolled cardiovascular disease, active bleeding disorders, or recent major gastrointestinal surgery.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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