Nintedanib Eignapharma (Nintedanib)

• Nintedanib acts on multiple fibrotic and angiogenic pathways, providing disease‑modifying benefits in several lung disorders.
• 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 (with docetaxel): enhances overall response rates and delays tumour progression.

• Nintedanib inhibits the intracellular kinase activity of 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 receptor tyrosine kinases, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby attenuating fibrotic remodeling in lung tissue.

Adverse reactions may vary in frequency and severity.

Common Side Effects

• Diarrhoea: mild to moderate, often manageable with hydration.
• Nausea: occasional, may improve with food intake.
• Vomiting: reported in a minority of patients.
• Decreased appetite: can lead to weight loss.
• Elevated liver enzymes: monitored through routine labs.
• Abdominal pain: generally transient.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury requiring discontinuation.
• Severe bleeding: especially when combined with anticoagulants.
• Cardiovascular events: rare cases of myocardial infarction.
• Interstitial lung disease exacerbation: worsening respiratory symptoms.
• Severe infections: opportunistic infections in immunocompromised patients.

• Before initiating therapy, evaluate liver function, bleeding risk, and concomitant medications.
• Baseline liver tests: obtain ALT, AST, and bilirubin levels.
• Bleeding risk assessment: avoid in patients with active ulcers or uncontrolled anticoagulation.
• Drug interactions: review concomitant CYP3A4 inhibitors or inducers.
• Pregnancy and lactation: discuss potential risks with the prescriber; data are limited.
• Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and direct sunlight.

Nintedanib may alter the exposure of several co‑administered drugs.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib plasma levels.
• Potent P‑glycoprotein inhibitors (e.g., cyclosporine): can raise systemic exposure.
• Anticoagulants (e.g., warfarin, DOACs): heightened bleeding risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise concentrations.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Gastric acid‑reducing agents: may affect absorption; monitor clinical response.