Nintedanib Zentiva (Nintedanib Esylate)

Nintedanib is a tyrosine kinase inhibitor employed in the management of fibrotic lung diseases and selected oncologic indications, acting on pathways that drive tissue scarring and tumor angiogenesis.

• Idiopathic pulmonary fibrosis: reduces the rate of forced vital capacity decline, helping to maintain respiratory function.
• Systemic sclerosis‑associated interstitial lung disease: limits fibrotic progression, supporting preservation of lung volumes and oxygenation.
• Non‑small cell lung cancer: combined with chemotherapy, inhibits tumor angiogenesis and proliferation, contributing to disease control.
• Quality of life: improves patient‑reported outcomes related to breathlessness and functional status in approved fibrotic conditions.

• Nintedanib inhibits multiple receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR 1‑3), fibroblast growth factor receptors (FGFR 1‑3), and platelet‑derived growth factor receptors (PDGFR‑α/β). By blocking these pathways, it reduces fibroblast proliferation, migration, and transformation, and exerts anti‑angiogenic effects that limit fibrotic tissue development and tumor vascularisation. The combined inhibition curtails signalling cascades that drive extracellular matrix deposition and neovascular growth, contributing to its antifibrotic and anticancer activity.

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

Common Side Effects

• Diarrhea: frequent loose stools often occurring early in therapy.
• Nausea: mild to moderate feeling of sickness.
• Vomiting: occasional episodes.
• Decreased appetite: reduced desire to eat.
• Abdominal pain: discomfort in the stomach area.
• Liver enzyme elevation: mild increases in ALT/AST.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury requiring monitoring.
• Bleeding events: increased risk of gastrointestinal or other bleeding.
• Cardiovascular events: such as myocardial infarction or stroke.
• Severe infections: opportunistic infections in immunocompromised patients.
• Interstitial lung disease exacerbation: worsening of underlying lung condition.

When prescribing Nintedanib, clinicians should consider several precautionary measures to ensure patient safety.

• Liver function monitoring: assess ALT, AST, and bilirubin before and during treatment.
• Gastrointestinal management: advise patients on hydration and antidiarrheal measures.
• Cardiovascular assessment: evaluate history of ischemic heart disease before initiating therapy.
• Bleeding risk evaluation: review concomitant anticoagulants and antiplatelet agents.
• Pregnancy and lactation: avoid use unless benefits outweigh potential risks.
• Store at ambient temperature: keep below 25°C in original packaging, protect from moisture.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors: may increase nintedanib exposure and toxicity.
• Anticoagulants: heightened risk of bleeding when combined.

Moderate Interactions (Monitor Closely)

• P-glycoprotein substrates: may alter plasma levels of nintedanib.
• CYP3A4 inducers: can reduce drug concentrations, diminishing effectiveness.
• NSAIDs: additive gastrointestinal side effects.
• Antifungal azoles: may increase exposure, requiring dose adjustment.