Nintedanib Sandoz (Nintedanib Esylate)

Nintedanib is used to treat fibrotic lung diseases and certain cancers by targeting multiple tyrosine kinase pathways.

• Idiopathic pulmonary fibrosis: slows the rate of forced vital capacity decline, helping to preserve lung function and improve quality of life.
• Systemic sclerosis‑associated interstitial lung disease: reduces progression of fibrotic changes, supporting maintenance of respiratory capacity in patients with this autoimmune condition.
• Non‑small cell lung cancer (selected patients): used as part of combination regimens to inhibit tumor angiogenesis and proliferation, contributing to disease control.

• Nintedanib inhibits the intracellular kinase activity of several receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR 1‑3), platelet‑derived growth factor receptors (PDGFR α/β) and fibroblast growth factor receptors (FGFR 1‑3). By blocking these pathways, the drug reduces endothelial cell proliferation, fibroblast activation and extracellular matrix deposition, thereby limiting angiogenesis and fibrotic tissue remodeling and associated inflammatory signaling cascades in the lungs and tumor microenvironment.

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

Common Side Effects

• Diarrhea: frequent loose stools, often manageable with diet and hydration.
• Nausea: mild to moderate feeling of sickness.
• Decreased appetite: reduced desire to eat.
• Liver enzyme elevation: mild increase in ALT/AST.

Serious or Rare Side Effects

• Hepatotoxicity: significant liver injury requiring monitoring.
• Bleeding events: increased risk of gastrointestinal or other bleeding.
• Cardiovascular events: such as myocardial infarction or stroke.

When prescribing Nintedanib, clinicians should consider several precautionary measures to ensure patient safety.

• Liver function monitoring: assess ALT, AST, and bilirubin before initiation and periodically during therapy.
• Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea or vomiting promptly.
• Cardiovascular assessment: evaluate history of ischemic heart disease before starting treatment.
• Bleeding risk evaluation: avoid use in patients with active bleeding or uncontrolled anticoagulation.
• Pregnancy and lactation: contraindicated; advise effective contraception and discuss risks with women of childbearing potential.
• Store at ambient temperature: keep below 25 °C in the original packaging, protect from moisture and direct sunlight.

Nintedanib can interact with other medicines, affecting its efficacy or safety profile.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure and toxicity.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.
• P-glycoprotein inhibitors (e.g., verapamil): can raise plasma concentrations.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inducers (e.g., rifampicin): may reduce effectiveness of nintedanib.
• Antifungal azoles with mild inhibition: may require dose adjustment.
• NSAIDs: concurrent use may increase gastrointestinal bleeding risk.