Product image of Nintedanib Aurobindo (Nintedanib) supplied by GNH India

Nintedanib Aurobindo

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Aurobindo (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Aurobindo, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for certain fibrotic lung disorders and selected cancers, acting to limit abnormal cell growth and tissue scarring.\n\nGNH India supplies Nintedanib Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Eugia Pharma (Malta) Ltd

1
Pack/s
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Indications & Clinical Uses

  • Nintedanib is used to treat diseases driven by abnormal fibroblast activity and tumor angiogenesis.\n\nIdiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.\nSystemic sclerosis‑associated interstitial lung disease: improves lung capacity and delays worsening.\nNon‑small cell lung cancer: used in combination therapy to inhibit tumor growth and angiogenesis.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases—including vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), and platelet‑derived growth factor receptors (PDGFR). By blocking these pathways, it reduces fibroblast proliferation, extracellular matrix deposition, and angiogenesis, thereby limiting fibrotic tissue formation and tumor vascular supply.

Side Effects

  • Nintedanib may cause a range of adverse reactions, from mild to severe.\n\nCommon Side Effects:\n- Diarrhea: frequent loose stools, often manageable with diet and hydration.\n- Nausea: feeling of sickness, may improve with food.\n- Vomiting: occasional expulsion of stomach contents.\n- Abdominal pain: discomfort or cramps in the stomach area.\n- Elevated liver enzymes: increased ALT/AST detected in blood tests.\n- Decreased appetite: reduced desire to eat.\n\nSerious or Rare Side Effects:\n- Hepatotoxicity: signs of liver injury such as jaundice or dark urine.\n- Severe bleeding: unexpected bruising or hemorrhage, especially with anticoagulants.\n- Cardiovascular events: hypertension or arterial thrombotic events.\n- Interstitial lung disease exacerbation: worsening respiratory symptoms.\n- Allergic reactions: rash, itching, or swelling of the face and throat.

Precautions & Warnings

  • Patients should be monitored for specific safety concerns before and during therapy.\n\nLiver function monitoring: obtain baseline and periodic ALT/AST tests.\nBleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use.\nCardiovascular evaluation: monitor blood pressure and signs of arterial events.\nPregnancy and lactation: avoid use as safety has not been established.\nDrug interactions: review all concomitant medications for potential CYP3A4 interactions.\nStore at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

  • Nintedanib can interact with several drug classes, requiring careful management.\n\nMajor Interactions (Avoid):\n- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.\n- Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.\n- Antiplatelet agents (e.g., aspirin, clopidogrel): additive hemorrhagic potential.\n\nModerate Interactions (Monitor Closely):\n- Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise plasma levels.\n- CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.\n- P‑glycoprotein substrates (e.g., digoxin): possible altered absorption.

Frequently Asked Questions

Nintedanib Aurobindo is prescribed 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.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, FGFR, and PDGFR—thereby reducing fibroblast proliferation, extracellular matrix formation, and new blood‑vessel growth. This dual antifibrotic and anti‑angiogenic action limits tissue scarring in the lungs and hampers tumor blood supply.

The specific dose and dosing schedule are determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and concomitant medications. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety of nintedanib in pregnancy and lactation has not been established. It is generally advised to avoid use in pregnant or nursing women unless the potential benefit justifies the potential risk, and this decision should be made by a qualified healthcare professional.

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 needs), and required import documentation.

Nintedanib differs from pirfenidone, the other approved antifibrotic for idiopathic pulmonary fibrosis, by targeting a broader range of tyrosine kinases. This results in a distinct side‑effect profile and may be preferred in patients who cannot tolerate pirfenidone or who have concurrent oncologic indications.

Store the tablets at ambient temperature, preferably below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and ensure the container is tightly closed to maintain product stability.

Nintedanib Aurobindo is taken orally, usually with food to reduce gastrointestinal discomfort. The tablets should be swallowed whole with a full glass of water and not crushed or chewed.

The most serious risks include liver injury (elevated transaminases or hepatitis), severe bleeding events, and cardiovascular complications such as hypertension or arterial thrombotic events. Patients should be monitored regularly for these conditions and report any concerning symptoms promptly.

Patients with known hypersensitivity to nintedanib or any of its excipients, those with severe hepatic impairment, uncontrolled bleeding disorders, or who are pregnant without a clear benefit should avoid using the medication. Final eligibility is determined by the treating physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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