Nintedanib Sandoz (Nintedanib)

Nintedanib is used to target fibrotic and oncologic pathways in several serious lung conditions.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening.
• Non‑small cell lung cancer (in combination therapy): enhances antitumor efficacy when used with standard chemotherapy.

• Nintedanib inhibits multiple 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, it reduces fibroblast proliferation, migration and transformation, thereby attenuating fibrotic tissue remodeling and tumor angiogenesis.

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

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: transient feeling of sickness.
• Decreased appetite: reduced desire to eat.
• Elevated liver enzymes: mild increases 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: rare cases of arterial thromboembolism.

When prescribing Nintedanib, clinicians should consider several safety measures.

• Liver function monitoring: assess ALT/AST before initiation and periodically during therapy.
• Gastrointestinal management: treat diarrhea promptly and maintain hydration.
• Cardiovascular assessment: evaluate arterial thromboembolism risk prior to use.
• Drug interactions: review concomitant medicines that affect CYP3A4 activity.
• Pregnancy and lactation: avoid unless benefits outweigh potential risks and specialist advice is obtained.
• Store at ambient temperature: keep below 25°C in the original container, protect from moisture and light.

Nintedanib can interact with other medicines, affecting its concentration or increasing adverse effects.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nintedanib levels, increasing toxicity risk.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly increase exposure.
• P‑glycoprotein substrates (e.g., digoxin): possible altered plasma concentrations.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy by lowering drug levels.