Nintedanib Cf (Nintedanib)

• Nintedanib is an antifibrotic agent used in chronic fibrotic lung disorders.
• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and delays functional deterioration.

• 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, leading to decreased extracellular matrix deposition and attenuation of fibrotic and angiogenic processes in the lung.

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

Common Side Effects

• Diarrhea: frequent, often mild to moderate.
• Nausea: may be accompanied by vomiting.
• Abdominal pain or discomfort.
• Decreased appetite and unintended weight loss.
• Elevated liver enzymes (ALT, AST).

Serious or Rare Side Effects

• Severe liver injury or hepatitis.
• Significant bleeding events, especially when combined with anticoagulants.
• Cardiovascular events such as myocardial infarction.
• Gastrointestinal perforations.
• Severe hypersensitivity reactions, including skin rash and angioedema.

• Before initiating therapy, clinicians should consider several safety measures.
• Monitor liver function: obtain baseline and periodic ALT/AST assessments.
• Assess bleeding risk: avoid concomitant use with strong anticoagulants unless necessary.
• Evaluate cardiovascular status: caution in patients with recent myocardial infarction.
• Pregnancy and lactation: use only if potential benefit outweighs unknown risks.
• Dose adjustment in hepatic impairment: consider reduced exposure in moderate impairment.
• Store at ambient temperature: keep in original container, protect from moisture and direct sunlight.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): markedly increase nintedanib plasma levels.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may increase exposure.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• P‑gp inhibitors (e.g., verapamil): modestly raise concentrations.
• NSAIDs or antiplatelet agents: monitor for additive bleeding risk.