Product image of Nintedanib Zentiva (Nintedanib Esylate) supplied by GNH India

Nintedanib Zentiva

Active Ingredient:
Nintedanib Esylate
Origin:
EU

Nintedanib Zentiva (Nintedanib Esylate)

Nintedanib, the active ingredient in Nintedanib Zentiva, 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 therapy for non‑small cell lung cancer in appropriate patients.

GNH India supplies Nintedanib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Nintedanib is indicated for fibrotic lung diseases and certain oncology regimens, targeting pathways that drive fibroblast activity and tumor angiogenesis.

  • 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 used with standard chemotherapy.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases including VEGFR 1‑3, PDGFR‑α/β and FGFR 1‑3. By blocking these pathways it reduces fibroblast proliferation, migration and extracellular matrix deposition, and also exerts anti‑angiogenic effects that contribute to its antifibrotic and anticancer activity.

Side Effects

Nintedanib may cause a range of adverse reactions, which are categorized by frequency and severity.

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

  • Hepatotoxicity: significant liver injury requiring monitoring.
  • Bleeding events: increased risk of gastrointestinal or other bleeding.
  • Cardiovascular events: rare cases of myocardial infarction or stroke.

Precautions & Warnings

When prescribing Nintedanib, clinicians should consider several safety measures.

  • Dose adjustment: required in patients with moderate hepatic impairment.
  • Monitoring: regular liver function tests are recommended.
  • Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors.
  • Pregnancy: safety not established; avoid use during pregnancy.
  • Bleeding risk: assess patient history of bleeding disorders.
  • Store at ambient temperature: keep in original packaging, protect from moisture and heat.

Avoid Interactions

Nintedanib interacts with several drug classes; awareness helps prevent adverse events.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise plasma levels.
  • P‑glycoprotein substrates (e.g., digoxin): potential altered concentrations.
  • Antacids containing magnesium/aluminum: may reduce absorption if taken simultaneously.

Frequently Asked Questions

Nintedanib Zentiva is prescribed to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and to be used in combination with chemotherapy for non‑small cell lung cancer. It targets fibrotic processes and tumor‑related angiogenesis.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby inhibiting fibroblast proliferation, migration and extracellular matrix formation, while also reducing angiogenesis. This dual action underlies its antifibrotic and anticancer effects.

The specific dose and dosing schedule are determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and other individual factors. No standardized regimen is provided here.

Safety data for Nintedanib during pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It is generally avoided in pregnant or nursing women unless the potential benefit outweighs the risk.

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 and any necessary import documentation.

The primary alternative for fibrotic lung disease is pirfenidone, which has a different mechanism—modulating cytokine production and oxidative stress. Nintedanib’s broader kinase inhibition offers anti‑angiogenic activity and is also approved for certain lung cancers, whereas pirfenidone is limited to idiopathic pulmonary fibrosis.

Nintedanib Zentiva should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and excessive heat. Keep the container tightly closed and out of direct sunlight.

The medication is taken orally, usually as whole tablets swallowed with a glass of water. It is generally recommended to be taken with food to lessen gastrointestinal discomfort, but patients should follow the specific instructions given by their healthcare provider.

Serious adverse events include hepatotoxicity (significant liver enzyme elevations or liver injury), bleeding complications (especially when combined with anticoagulants), and cardiovascular events such as myocardial infarction or stroke. Prompt medical evaluation is advised if any of these occur.

Patients with severe hepatic impairment, uncontrolled bleeding disorders, or those taking strong CYP3A4 inhibitors should avoid Nintedanib. Additionally, individuals who are pregnant, planning pregnancy, or breastfeeding should not use it unless a clinician determines the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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