Nintedanib Sandoz (Nintedanib)

• Nintedanib is used in diseases characterized by abnormal fibroblast activity and angiogenesis, primarily within the pulmonary and oncologic fields.
• Idiopathic pulmonary fibrosis: reduces the rate of forced vital capacity decline, helping to preserve lung function and delay disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function parameters and slows the worsening of respiratory symptoms in affected patients.
• Non‑small cell lung cancer: administered as part of combination regimens to inhibit tumor angiogenesis, thereby limiting tumor growth and spread.

• Nintedanib blocks the intracellular kinase activity of several 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 inhibiting these pathways, the drug reduces endothelial cell proliferation, angiogenesis, and fibroblast activation, which are key processes in fibrotic tissue formation and tumor vascularization. The simultaneous inhibition of multiple pathways contributes to its antifibrotic and antineoplastic effects.

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

Common Side Effects

• Diarrhea: frequent loose stools that may lead to dehydration.
• Nausea: feeling of sickness often accompanied by reduced appetite.
• Vomiting: occasional episodes, usually mild to moderate.
• Abdominal pain: cramping or discomfort in the stomach region.
• Elevated liver enzymes: mild increases in ALT/AST observed in routine monitoring.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury requiring discontinuation.
• Bleeding events: gastrointestinal or pulmonary hemorrhage, especially with anticoagulants.
• Cardiovascular events: myocardial infarction, arterial thromboembolism, or hypertension.

When prescribing Nintedanib, clinicians should observe several precautionary measures to minimize risks.

• Liver function monitoring: assess baseline ALT/AST and repeat regularly during therapy.
• Bleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use before initiation.
• Cardiovascular evaluation: screen for history of ischemic heart disease or uncontrolled hypertension.
• Pregnancy and lactation: avoid use in pregnant or breastfeeding women unless benefits outweigh potential risks, as safety data are limited.
• Drug interactions: review concomitant medications for strong CYP3A4 inhibitors or inducers.
• Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

• Nintedanib interacts with several medicines; understanding the level of interaction helps