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 tablet for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used in combination with chemotherapy 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 acts on multiple fibrotic and oncogenic pathways, providing therapeutic benefit in several lung‑related 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 (in combination with chemotherapy): contributes to tumor growth inhibition when used with standard chemotherapy regimens.

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‑related vascular growth.

Side Effects

Nintedanib may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhoea: frequent, often mild to moderate.
  • Nausea and vomiting: may occur after dosing.
  • Abdominal pain: intermittent discomfort.
  • Decreased appetite: reduced food intake.
  • Weight loss: gradual reduction in body weight.
  • Elevated liver enzymes: mild transaminase rise.

Serious or Rare Side Effects

  • Hepatotoxicity: significant liver injury requiring monitoring.
  • Bleeding events: gastrointestinal or other hemorrhage.
  • Cardiovascular complications: myocardial infarction or arterial thrombosis.
  • Severe infections: opportunistic or bacterial infections.
  • Gastrointestinal perforation: rare but potentially life‑threatening.
  • Interstitial lung disease exacerbation: worsening respiratory status.

Precautions & Warnings

  • Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor key parameters.
  • Monitor liver function: obtain baseline and periodic LFTs during treatment.
  • Assess cardiovascular status: check blood pressure and cardiac history.
  • Avoid in severe hepatic impairment: contraindicated in patients with Child‑Pugh C disease.
  • Use caution with anticoagulants: increased risk of bleeding, monitor coagulation parameters.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Nintedanib can interact with several drug classes, influencing its safety and efficacy.

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
  • Antacids containing magnesium/aluminum: may affect absorption; separate dosing by at least 2 hours.
  • Diuretics: monitor for dehydration and renal function changes.

Frequently Asked Questions

Nintedanib Stada is prescribed to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and, in combination with chemotherapy, non‑small cell lung cancer. It works by targeting pathways that drive fibrosis and tumor‑related angiogenesis, helping to slow disease progression and improve patient outcomes.

Nintedanib blocks multiple receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby inhibiting fibroblast proliferation, new blood‑vessel formation, and extracellular matrix deposition. This multi‑targeted inhibition reduces fibrotic tissue remodeling in the lungs and limits tumor‑associated vascular growth when used with chemotherapy.

The specific dose and dosing schedule are determined by the prescribing clinician based on the patient’s condition, weight, liver function and concomitant therapies. Healthcare professionals follow approved labeling and clinical guidelines to individualise therapy for each indication.

Safety data for Nintedanib in pregnancy and lactation are limited, and the product is classified as contraindicated or not recommended for use in these populations. Women of child‑bearing potential should use effective contraception, and breastfeeding mothers should discuss alternatives with their healthcare provider.

To place an order, 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 idiopathic pulmonary fibrosis is pirfenidone, another antifibrotic agent with a different mechanism focused on cytokine modulation. Nintedanib’s multi‑kinase inhibition offers broader activity against angiogenic and fibrotic pathways, which can be advantageous in certain patients, while pirfenidone may have a more favorable gastrointestinal profile for some individuals.

Store Nintedanib Stada at room temperature, below 25 °C, in the original blister pack or container. Protect the tablets from moisture, excessive heat and direct sunlight to maintain potency throughout the shelf life.

Nintedanib Stada is taken orally, usually as a whole tablet swallowed with a glass of water. It can be taken with or without food, but patients should follow the prescriber’s instructions regarding timing relative to meals to optimise absorption and minimize gastrointestinal discomfort.

Clinicians and patients should be vigilant for signs of liver injury (elevated transaminases, jaundice), severe bleeding events, cardiovascular complications such as myocardial infarction, and rare but serious gastrointestinal perforations. Prompt medical evaluation is essential if any of these symptoms arise.

Nintedanib is contraindicated in patients with severe hepatic impairment (Child‑Pugh C), those with known hypersensitivity to the active ingredient or any excipients, and individuals receiving strong CYP3A4 inhibitors that cannot be discontinued. Caution is also advised for patients with uncontrolled cardiovascular disease or active bleeding disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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