Nintedanib Stada (Nintedanib)

Nintedanib is indicated for fibrotic lung disorders and selected oncologic indications, acting on pathways that drive fibroblast proliferation and tumor angiogenesis.

• 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 specific histology): used in combination therapy to inhibit tumor growth and angiogenesis.

• 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, extracellular matrix deposition, and pathological angiogenesis, thereby limiting fibrosis and tumor vascularisation.

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

Common Side Effects

• Diarrhoea: frequent, often mild to moderate in intensity.
• Nausea and vomiting: may occur early in treatment.
• Decreased appetite: can contribute to weight loss.
• Abdominal pain: intermittent discomfort.
• Elevated liver enzymes (ALT/AST): usually reversible.
• Headache: transient and mild.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury requiring monitoring.
• Bleeding events: increased risk of gastrointestinal or other hemorrhage.
• Cardiovascular events: such as myocardial infarction or hypertension.
• Severe infections: opportunistic infections in immunocompromised patients.
• Interstitial lung disease exacerbation: rare worsening of underlying lung condition.
• Severe skin reactions: including Stevens‑Johnson syndrome.

Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor relevant parameters.

• Liver function monitoring: assess ALT/AST before start and periodically during treatment.
• Bleeding risk assessment: avoid in patients with active bleeding or uncontrolled anticoagulation.
• Cardiovascular evaluation: monitor blood pressure and cardiac status, especially in patients with pre‑existing disease.
• Pregnancy and lactation: avoid use unless benefits outweigh potential risks; discuss with a specialist.
• Drug‑specific contraindications: review concomitant medications that may increase exposure or toxicity.
• Store at ambient temperature: keep below 25 °C, retain in original packaging, and protect from moisture and direct sunlight.

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): may markedly increase nintedanib plasma levels.
• Potent P‑gp/BCRP inhibitors (e.g., verapamil, cyclosporine): can raise systemic exposure and risk of toxicity.
• High‑dose anticoagulants or antiplatelet agents: elevate bleeding risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may require dose adjustment.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): can reduce efficacy by lowering drug concentrations.
• Acid‑reducing agents (e.g., proton‑pump inhibitors): may affect absorption; monitor clinical response.