Nintedanib Sandoz (Nintedanib)

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

• Idiopathic pulmonary fibrosis: slows disease progression, reduces decline in forced vital capacity and improves survival outcomes.
• Systemic sclerosis‑associated interstitial lung disease: limits lung function deterioration and may improve forced vital capacity in affected adults.
• Non‑small cell lung cancer (selected patients): inhibits tumor angiogenesis and proliferation, contributing to disease control when used according to oncologic guidelines.

• 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 attenuating fibrotic tissue remodeling and tumor growth.

Common Side Effects

• Nausea: mild to moderate gastrointestinal upset.
• Diarrhea: frequent loose stools, often manageable with diet.
• Vomiting: occasional episodes, usually early in therapy.
• Decreased appetite: reduced food intake leading to weight loss.
• Abdominal pain: discomfort in the stomach region.
• Liver enzyme elevation: mild increases in ALT/AST.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury requiring monitoring.
• Bleeding events: gastrointestinal or intracranial hemorrhage, especially with anticoagulants.
• Cardiovascular events: myocardial infarction, arterial thrombosis, or hypertension.
• Severe infections: opportunistic infections in immunocompromised patients.
• Pulmonary embolism: rare clot formation in pulmonary arteries.

Before initiating therapy, clinicians should assess baseline organ function and comorbid conditions.

• Liver function monitoring: perform baseline and periodic liver enzyme tests.
• Bleeding risk assessment: evaluate for anticoagulant use or history of hemorrhage.
• Cardiovascular evaluation: monitor blood pressure and signs of ischemic events.
• Dose adjustment in hepatic impairment: reduce dose or avoid in severe impairment.
• Pregnancy and lactation: avoid use unless benefits outweigh potential risks.
• Store at below 25°C: keep in the original pack, protect from moisture and light.

Nintedanib may interact with drugs that affect its metabolism or increase bleeding risk.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma levels.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): increase bleeding potential.
• Antiplatelet agents (e.g., aspirin, clopidogrel): heighten hemorrhage risk.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• P‑gp inhibitors (e.g., verapamil): modestly increase exposure.
• Diuretics: may affect fluid balance and renal function.