Nintedanib Sandoz (Nintedanib)

Nintedanib is used to treat fibrotic lung diseases and certain cancers by inhibiting pathways that drive fibroblast proliferation and tumor angiogenesis.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: improves pulmonary outcomes and stabilizes fibrosis.
• Non‑small cell lung cancer (in combination therapy): contributes to tumor growth inhibition and may extend progression‑free survival.

• Nintedanib blocks 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 inhibiting these signaling pathways, the drug reduces endothelial and fibroblast cell proliferation, migration and transformation, thereby limiting angiogenesis and fibrotic tissue formation in the lungs and tumor microenvironment. The combined inhibition curtails pathological remodeling and supports preservation of normal tissue architecture.

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: mild to moderate feeling of sickness.
• Vomiting: occasional episodes of stomach emptying.
• Elevated liver enzymes: increases in ALT/AST observed in laboratory tests.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury requiring monitoring.
• Bleeding events: gastrointestinal or other hemorrhage.
• Cardiovascular events: arterial thromboembolism or myocardial infarction.

When prescribing Nintedanib, clinicians should consider several precautionary measures to minimize risk.

• Liver function monitoring: assess ALT, AST and bilirubin before treatment and periodically during therapy.
• Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea or vomiting promptly.
• Drug interactions: review concomitant medications that affect CYP3A4 metabolism.
• Pregnancy and lactation: avoid use unless potential benefit justifies potential risk; discuss with obstetric specialist.
• Contraindications: do not use in patients with known hypersensitivity to nintedanib or its excipients.
• Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original container.

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

Major Interactions (Avoid)

• Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may markedly reduce nintedanib exposure.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): increased risk of bleeding.
• Potent CYP3A4 inhibitors (e.g., ketoconazole): may raise nintedanib levels and toxicity.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly increase exposure.
• P‑glycoprotein inhibitors (e.g., verapamil): could elevate plasma concentrations.
• NSAIDs or aspirin: additive risk of gastrointestinal bleeding.