Nintedanib Zentiva (Nintedanib Esylate)

• Nintedanib targets fibrotic lung disease and certain cancers by inhibiting multiple growth‑factor receptors.
• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity in affected patients.
• Non‑small cell lung cancer (in combination therapy): contributes to tumor control when used with chemotherapy.

• Nintedanib blocks 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 inhibiting these pathways, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition that drive fibrosis and tumor growth.

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

Common Side Effects

• Diarrhea: often mild to moderate, may require supportive care.
• Nausea and vomiting: usually transient.
• Abdominal pain or discomfort.
• Decreased appetite and weight loss.
• Elevated liver enzymes (ALT, AST).
• Headache.

Serious or Rare Side Effects

• Severe liver injury or hepatitis.
• Gastrointestinal perforation.
• Significant bleeding events.
• Cardiovascular complications such as myocardial infarction.
• Severe infections.
• Pulmonary embolism.

Before initiating therapy, clinicians should assess baseline organ function and consider potential risks.

• Liver function monitoring: obtain baseline tests and repeat periodically.
• Bleeding risk: evaluate concomitant anticoagulant or antiplatelet use.
• Gastrointestinal tolerance: monitor for severe or persistent diarrhea.
• Pregnancy and lactation: use only if potential benefit justifies potential risk.
• Drug interactions: review all concomitant medications for CYP3A4 or P‑gp effects.
• Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.

Nintedanib interacts with several drug classes that can alter its exposure or increase adverse events.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): may increase nintedanib levels.
• Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin): may reduce efficacy.
• Potent P‑gp inhibitors (e.g., verapamil): can raise systemic exposure.
• Anticoagulants/antiplatelet agents: heightened bleeding risk.
• High‑dose aspirin: may exacerbate gastrointestinal toxicity.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin): may modestly increase exposure.
• Antacids or proton‑pump inhibitors: could affect absorption; separate dosing by at least 2 hours.
• NSAIDs: monitor for additive gastrointestinal bleeding.
• Herbal supplements affecting CYP enzymes (e.g., St John's wort): may lower drug levels.
• Diuretics: watch for electrolyte disturbances if severe diarrhea occurs.