Nintedanib Eugia (Nintedanib)

Nintedanib is used to treat fibrotic lung disorders and certain cancers by targeting pathways that drive fibroblast activity and tumor angiogenesis.

• 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 (in combination therapy): enhances treatment efficacy when combined with chemotherapy.

• 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 endothelial cell proliferation, fibroblast activation, and angiogenesis, thereby limiting fibrotic tissue formation and tumor vascular support. The simultaneous blockade of these three receptor families disrupts signaling cascades that promote extracellular matrix deposition and neovascularization, key processes in pulmonary fibrosis and tumor growth.

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

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate, may require antidiarrheal medication.
• Nausea: feeling of sickness, may be transient and improve with food intake.
• Vomiting: occasional episodes, usually self‑limiting.
• Abdominal pain: discomfort in the stomach area, can be crampy.
• Decreased appetite: reduced desire to eat, potentially leading to weight loss.
• Liver enzyme elevation: mild increase in ALT/AST, usually reversible.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury, indicated by marked enzyme rise and jaundice.
• Bleeding events: gastrointestinal or other hemorrhage, may present as blood in stool or bruising.
• Cardiovascular events: arterial thromboembolism or myocardial infarction, requiring urgent medical attention.
• Severe infections: opportunistic infections in immunocompromised patients, such as pneumonia.
• Interstitial lung disease worsening: rapid progression of underlying lung disease, with increased dyspnea.

When prescribing Nintedanib, clinicians should consider several precautionary measures to minimize risks and ensure safe use.

• Liver function monitoring: assess baseline ALT/AST and repeat periodically during therapy.
• Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea.
• Cardiovascular assessment: evaluate history of arterial thromboembolism before initiating treatment.
• Pregnancy and lactation: avoid use in pregnancy; discontinue if pregnancy occurs; safety in breastfeeding is unknown.
• Drug interactions: review concomitant medications that affect CYP3A4 metabolism.
• Store at ambient temperature: keep tablets below 25 °C in the original container, protected from moisture and light.

Nintedanib can interact with other medicines, influencing its plasma levels or increasing the risk of adverse events.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors: may markedly increase nintedanib exposure, raising toxicity risk.
• Anticoagulants (e.g., warfarin): combined use can enhance bleeding tendency.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors or inducers: may alter drug concentrations, requiring dose adjustment.
• P-glycoprotein substrates: concurrent use may affect absorption.
• Gastric acid‑reducing agents: may reduce oral bioavailability of nintedanib.