Nintedanib Accordpharma (Nintedanib)

Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncologic pathways.

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

• Nintedanib inhibits the intracellular kinase activity of 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, angiogenesis, and extracellular matrix deposition, thereby attenuating fibrotic remodeling and tumor vascularisation.

Nintedanib may cause a range of adverse reactions.

Common Side Effects

• Diarrhoea: frequent loose stools, often mild to moderate.
• Nausea: sensation of unease in the stomach.
• Vomiting: expulsion of stomach contents.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: increased ALT/AST levels.
• Fatigue: feeling of tiredness or lack of energy.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury, jaundice, or hepatitis.
• Bleeding events: gastrointestinal or other serious haemorrhage.
• Cardiovascular events: arterial thromboembolism or myocardial infarction.
• Severe infections: opportunistic or bacterial infections.
• Interstitial lung disease worsening: acute respiratory decline.
• Allergic reactions: rash, urticaria, or anaphylaxis.

Before initiating Nintedanib, consider the following safety measures.

• Liver function monitoring: check ALT, AST, and bilirubin regularly.
• Gastrointestinal assessment: manage diarrhoea promptly to avoid dehydration.
• Bleeding risk evaluation: avoid concomitant anticoagulants unless essential.
• Cardiovascular review: assess history of arterial events.
• Pregnancy and lactation: avoid use; discuss alternatives with a specialist.
• Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and light.

Nintedanib can interact with several drug classes.

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• P‑glycoprotein substrates (e.g., digoxin): possible altered exposure.
• NSAIDs and antiplatelet agents: additive bleeding potential.