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

Nintedanib Al

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Al (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Al, is a tyrosine kinase inhibitor presented as an oral formulation for systemic use. It is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and selected non‑small cell lung cancer. The drug blocks several growth‑factor receptors that drive fibroblast activity and abnormal vascular formation, slowing disease progression. It meets EU pharmaceutical standards and is prescribed by pulmonology and oncology specialists.

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

Manufacturer / TM Owner

Aliud Pharma Gmbh

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Indications & Clinical Uses

Nintedanib is used in fibrotic lung disorders and certain oncologic settings, targeting pathways that promote fibroblast proliferation and tumor angiogenesis.

  • Idiopathic pulmonary fibrosis: slows decline in lung function, reduces forced vital capacity loss, and may improve quality of life.
  • Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and stabilises respiratory status in affected patients.
  • Non‑small cell lung cancer: used in combination regimens to inhibit tumour growth and angiogenesis, contributing to disease control.

How It Works

  • Nintedanib inhibits the intracellular kinase activity of multiple 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, migration, and transformation, and exerts anti‑angiogenic effects that limit pathological tissue remodeling in the lung and tumour microenvironment.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent loose stools, often manageable with diet and antidiarrheal agents.
  • Nausea: mild to moderate feeling of queasiness.
  • Vomiting: occasional episodes.
  • Elevated liver enzymes: increases in ALT/AST observed in laboratory tests.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury requiring monitoring and possible discontinuation.
  • Cardiovascular events: arterial thromboembolism or myocardial infarction.
  • Gastrointestinal perforation: rare but serious intestinal ulceration.

Precautions & Warnings

When prescribing Nintedanib, clinicians should observe several safety considerations to minimise risk.

  • Liver function monitoring: check ALT/AST before treatment and periodically during therapy.
  • Bleeding risk assessment: avoid use in patients with active bleeding or on strong anticoagulants.
  • Gastrointestinal health: monitor for severe diarrhea or ulceration, especially in patients with prior GI disease.
  • Cardiovascular evaluation: assess history of arterial thrombotic events before initiating therapy.
  • Pregnancy and lactation: contraindicated unless benefits outweigh risks; discuss with obstetric specialist.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture and light.

Avoid Interactions

Nintedanib can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase Nintedanib exposure, raising toxicity risk.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): combined use can enhance bleeding tendency.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise plasma levels.
  • P‑glycoprotein substrates (e.g., digoxin): potential for altered absorption.
  • Antacids containing aluminium or magnesium: may reduce oral bioavailability if taken simultaneously.

Frequently Asked Questions

Nintedanib Al is prescribed for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for use in combination therapy in certain cases of non‑small cell lung cancer. In each indication the drug aims to slow disease progression by targeting pathways that drive fibrosis or tumour angiogenesis.

Nintedanib blocks the activity of several receptor tyrosine kinases, notably VEGFR 1‑3, PDGFR α/β and FGFR 1‑3. Inhibiting these receptors reduces fibroblast proliferation, migration and transformation, and also limits abnormal blood‑vessel formation, thereby mitigating fibrotic tissue development and tumour growth.

The exact dose of Nintedanib Al is set by the prescribing clinician based on the specific indication, patient characteristics, liver function, and any concomitant medications. Dosage adjustments are made according to clinical response and tolerability, and patients should follow the prescriber’s instructions precisely.

Safety data for Nintedanib in pregnancy and lactation are limited. The drug should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made in consultation with an obstetric specialist. Breastfeeding is generally not recommended while receiving Nintedanib.

To request Nintedanib Al, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will ask for trade or institutional credentials. The sales team then replies with pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

The primary alternative for fibrotic lung disease is pirfenidone, another antifibrotic agent. While both aim to slow disease progression, Nintedanib targets multiple tyrosine‑kinase pathways, offering broader anti‑angiogenic activity, whereas pirfenidone works mainly through modulation of inflammatory and oxidative pathways. Choice of therapy depends on patient tolerance, comorbidities and physician assessment.

Nintedanib Al should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging to protect it from moisture and light. Do not store in areas of high humidity or direct sunlight, and keep out of reach of children.

Nintedanib Al is taken orally, usually with a full glass of water. It is generally recommended to swallow the capsule whole and not to crush or chew it. Dosing times (e.g., with food) should follow the prescriber’s guidance to optimise absorption and minimise gastrointestinal discomfort.

The most serious adverse events associated with Nintedanib include hepatotoxicity (significant elevation of liver enzymes or liver failure), severe bleeding events, arterial thromboembolism, and rare gastrointestinal perforation. Patients should be monitored regularly for liver function, signs of bleeding, and any acute abdominal pain.

Nintedanib is contraindicated in patients with known hypersensitivity to the active substance or any excipients, those with active severe liver disease, uncontrolled bleeding disorders, or recent major arterial thrombotic events. Caution is also advised for patients on strong CYP3A4 inhibitors, and it should be avoided in pregnancy unless absolutely necessary.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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