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

Nintedanib Newbury

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Newbury (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Newbury, is a tyrosine kinase inhibitor presented as an unknown/unknown for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in adult patients.

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

Manufacturer / TM Owner

Newbury Pharmaceuticals Ab

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Indications & Clinical Uses

Nintedanib is indicated for several fibrotic and oncologic conditions where inhibition of multiple tyrosine kinases slows disease progression.

  • Idiopathic pulmonary fibrosis: reduces decline in lung function and delays overall disease progression.
  • Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and slows worsening of fibrotic changes.
  • Non‑small cell lung cancer (in combination therapy): contributes to tumor growth inhibition and improves progression‑free survival.

How It Works

  • Nintedanib blocks the activity of multiple receptor tyrosine kinases—including vascular endothelial growth factor receptors (VEGFR), platelet‑derived growth factor receptors (PDGFR), and fibroblast growth factor receptors (FGFR). By inhibiting these pathways, it reduces fibroblast proliferation, angiogenesis, and the downstream fibrotic processes that drive lung scarring and tumor vascularization.

Side Effects

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

Common Side Effects

  • Diarrhoea: usually mild to moderate and may improve with supportive care.
  • Nausea: often transient and manageable with anti‑emetics.
  • Decreased appetite: can lead to weight loss if persistent.
  • Elevated liver enzymes: requires periodic monitoring.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury, indicated by marked transaminase elevation.
  • Bleeding events: increased risk of gastrointestinal or other bleeding.
  • Cardiovascular events: rare cases of myocardial infarction or stroke have been reported.

Precautions & Warnings

Before initiating therapy, clinicians should assess patient‑specific factors and monitor for potential complications.

  • Liver function: evaluate baseline enzymes and repeat monitoring during treatment.
  • Renal function: assess creatinine clearance, especially in patients with pre‑existing impairment.
  • Gastrointestinal health: counsel patients on managing diarrhoea and dehydration.
  • Concomitant anticoagulants: monitor for enhanced bleeding risk.
  • Pregnancy and lactation: avoid use unless benefits clearly outweigh potential risks.
  • Store at ambient temperature below 25°C: keep in the original container, protect from moisture and light.

Avoid Interactions

Nintedanib can interact with other medicines, altering its exposure or increasing toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nintedanib plasma levels and increase adverse events.
  • Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.

Moderate Interactions (Monitor Closely)

  • P‑glycoprotein inhibitors (e.g., verapamil): can modestly increase exposure.
  • Co‑administration with other anti‑angiogenic agents: additive toxicity may occur.
  • High‑fat meals: may affect absorption, so advise consistent intake with respect to meals.

Frequently Asked Questions

Nintedanib Newbury is prescribed for adult patients with idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for non‑small cell lung cancer when used in combination with other anticancer agents. In each case, the drug aims to slow disease progression by targeting key pathways involved in fibrosis and tumor angiogenesis.

Nintedanib blocks several receptor tyrosine kinases—VEGFR, PDGFR and FGFR—thereby inhibiting fibroblast proliferation, new blood‑vessel formation, and the cascade of signals that lead to tissue scarring and tumor growth. This multi‑targeted inhibition reduces the pathological processes that underlie pulmonary fibrosis and certain cancers.

The specific dosage and schedule of Nintedanib Newbury are determined by the prescribing clinician based on the patient’s condition, weight, renal and hepatic function, and other individual factors. Healthcare professionals should follow the latest prescribing information and adjust the regimen as needed.

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. Women of childbearing 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 fibrotic lung disease is pirfenidone, another antifibrotic agent. While both aim to slow disease progression, Nintedanib targets multiple tyrosine kinases, offering a broader anti‑angiogenic profile, whereas pirfenidone’s mechanism involves modulation of cytokine production and oxidative stress. Choice of therapy depends on efficacy, tolerability, drug‑drug interactions and individual patient factors.

Nintedanib Newbury should be stored at ambient temperature below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and avoid exposure to extreme temperatures. Do not refrigerate or freeze the tablets unless specifically instructed by the supplier.

The medication is taken orally, usually with food to reduce gastrointestinal upset. Patients should swallow the tablet whole with a full glass of water and follow the dosing schedule prescribed by their clinician. Consistency with respect to meals helps maintain stable drug absorption.

Serious adverse events include significant liver injury (marked elevation of transaminases), severe bleeding episodes, and rare cardiovascular events such as myocardial infarction or stroke. Patients should report any signs of jaundice, unusual bruising, blood in stools, or chest pain to their healthcare provider promptly.

Nintedanib is contraindicated in patients with known hypersensitivity to the active ingredient or any excipients, and in those with severe hepatic impairment. Caution is also advised for individuals taking strong CYP3A4 inhibitors, anticoagulants, or who have uncontrolled bleeding disorders. Pregnant or breastfeeding women should only use it if clearly indicated.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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