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

Nintedanib Accord

Active Ingredient:
Nintedanib
Origin:
EU

Nintedanib Accord (Nintedanib)

Nintedanib, the active ingredient in Nintedanib Accord, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is used to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer in adult patients.

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

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

Nintedanib is an antifibrotic agent employed in fibrotic lung diseases and selected oncologic indications.

  • Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
  • Systemic sclerosis‑associated interstitial lung disease: improves lung capacity and delays worsening.
  • Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth.

How It Works

  • Nintedanib inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR‑1, 2, 3), fibroblast growth factor receptors (FGFR‑1, 2, 3) and platelet‑derived growth factor receptors (PDGFR‑α, β). By blocking these pathways, it reduces fibroblast proliferation, extracellular matrix deposition, and angiogenesis, thereby limiting fibrotic tissue development and tumor vascularisation.

Side Effects

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

Common Side Effects

  • Nausea
  • Diarrhea
  • Vomiting
  • Decreased appetite
  • Abdominal pain
  • Headache

Serious or Rare Side Effects

  • Elevated liver enzymes (ALT/AST)
  • Bleeding events
  • Cardiovascular complications (e.g., myocardial infarction)
  • Severe infections
  • Gastrointestinal perforation
  • Severe skin reactions (e.g., Stevens‑Johnson syndrome)

Precautions & Warnings

Before initiating therapy, clinicians should assess patient‑specific risk factors and monitor appropriately.

  • Renal or hepatic impairment: adjust monitoring and consider dose evaluation.
  • Bleeding risk: avoid concomitant anticoagulants unless medically necessary.
  • Cardiovascular disease: monitor blood pressure and cardiac status regularly.
  • Pregnancy and lactation: use only if potential benefits outweigh risks.
  • Drug interactions: review concomitant medications for CYP3A4 substrates and inhibitors.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original container.

Avoid Interactions

Nintedanib may interact with several drug classes; awareness helps prevent adverse outcomes.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase nintedanib exposure.
  • Anticoagulants (e.g., warfarin): heightened risk of bleeding.
  • P‑glycoprotein inhibitors (e.g., verapamil): may raise plasma levels.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampicin): may reduce efficacy.
  • Antiplatelet agents (e.g., aspirin): monitor for bleeding.
  • Diuretics: monitor renal function and electrolytes.

Frequently Asked Questions

Nintedanib Accord is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and for use in combination regimens for certain non‑small cell lung cancers. It targets fibrotic processes and tumor‑related angiogenesis to help 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 activity underlies its therapeutic effect in lung fibrosis and selected cancers.

The prescribed dose of Nintedanib Accord is determined by the treating physician based on the specific indication, patient characteristics, and clinical response. Dosage information is provided in the product label and should be followed exactly as directed by a qualified healthcare professional.

Safety data for Nintedanib Accord in pregnancy and lactation are limited. It should only be used when the potential benefit justifies the possible risk to the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment and for a period after discontinuation as advised by their clinician.

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. While both slow disease progression, nintedanib targets a broader range of tyrosine kinases, which may offer additional benefits in certain cancers. Choice between them depends on patient tolerance, comorbidities, drug‑interaction profile and physician judgment.

Nintedanib Accord should be stored at ambient temperature, preferably below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing it in humid or excessively hot environments.

Nintedanib Accord 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. Administration timing and any dose adjustments are determined by the prescribing clinician.

Serious risks include elevated liver enzymes, significant bleeding, cardiovascular events such as myocardial infarction, severe infections, gastrointestinal perforation, and rare but severe skin reactions like Stevens‑Johnson syndrome. Patients should report any unusual symptoms promptly and undergo regular laboratory monitoring as advised.

Nintedanib Accord is contraindicated in patients with known hypersensitivity to nintedanib or any of its excipients. Caution is advised for individuals with severe hepatic impairment, uncontrolled bleeding disorders, or those receiving strong CYP3A4 inhibitors. Pregnant or nursing women should only use it when the benefit outweighs potential risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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