Nintedanib Sandoz (Nintedanib)

• Nintedanib is used in fibrotic lung disorders and selected oncologic settings, targeting disease pathways that involve fibroblast proliferation and angiogenesis.
• Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and stabilizes respiratory symptoms.
• Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth and angiogenesis.

• Nintedanib inhibits the intracellular tyrosine kinase activity of 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 receptors, the drug reduces endothelial cell proliferation, fibroblast activation and extracellular matrix deposition, thereby limiting fibrosis and tumor angiogenesis. The simultaneous inhibition of these pathways results in a broad anti‑fibrotic and anti‑angiogenic effect, which is central to its therapeutic activity in pulmonary fibrosis and certain cancers.

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: feeling of sickness, may be transient.
• Vomiting: occasional episodes.
• Abdominal pain: discomfort in the stomach area.
• Elevated liver enzymes: increase in ALT/AST levels.

Serious or Rare Side Effects

• Hepatic failure: severe liver injury requiring monitoring.
• Bleeding events: gastrointestinal or other hemorrhage.
• Cardiovascular events: arterial thromboembolism or myocardial infarction.
• Severe infections: opportunistic or serious bacterial infections.
• Perforations of the gastrointestinal tract: rare but potentially life‑threatening.

Before initiating therapy, clinicians should assess baseline health status and monitor for specific risks.

• Liver function monitoring: perform baseline and periodic ALT/AST tests.
• Bleeding risk assessment: evaluate for anticoagulant use and history of hemorrhage.
• Cardiovascular evaluation: monitor for signs of arterial thrombotic events.
• Pregnancy and lactation: avoid use unless benefits outweigh risks; discuss with healthcare provider.
• Drug interactions: review concomitant medications, especially CYP3A4 inhibitors or inducers.
• Store at ambient temperature: keep below 25 °C, in original container, protected from moisture and light.

Nintedanib interacts with several drug classes; some combinations should be avoided while others require close monitoring.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
• P‑glycoprotein inhibitors (e.g., itraconazole): can raise plasma levels.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• Antacids containing aluminum or magnesium: may affect absorption; separate dosing.
• Herbal supplements (e.g., St John’s wort): potential induction of metabolism.