Nintedanib Stada (Nintedanib)

Nintedanib is indicated for fibrotic lung diseases and certain oncologic regimens, targeting pathways that drive fibroblast activity and tumor growth.

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

• Nintedanib inhibits multiple receptor tyrosine kinases, specifically 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 angiogenesis, leading to decreased extracellular matrix formation and tumor vascularization. The inhibition is achieved through competitive binding at the ATP‑binding site of the kinases, resulting in downstream signal attenuation.

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

Common Side Effects

• Diarrhea: frequent loose stools that may require supportive care.
• Nausea: feeling of sickness often accompanied by reduced appetite.
• Vomiting: occasional expulsion of stomach contents.
• Elevated liver enzymes: mild increases in ALT/AST observed in laboratory tests.

Serious or Rare Side Effects

• Severe liver injury: rare cases of hepatitis or hepatic failure.
• Bleeding events: increased risk of gastrointestinal or pulmonary hemorrhage.
• Cardiovascular events: rare occurrences of myocardial infarction or arterial thrombosis.

When prescribing Nintedanib, clinicians should consider several safety measures and monitoring requirements.

• Liver function monitoring: assess ALT, AST and bilirubin before treatment and periodically during therapy.
• Gastrointestinal management: advise patients to stay hydrated and report persistent diarrhea.
• Cardiovascular assessment: evaluate history of ischemic heart disease before initiating therapy.
• Drug interactions: avoid concomitant use with strong CYP3A4 or P‑gp inhibitors without dose adjustment.
• Pregnancy and lactation: contraindicated unless benefits outweigh risks; discuss with obstetric specialist.
• Store at ambient temperature: keep below 25 °C in the original packaging, protect from moisture and light.

Nintedanib interacts with several medicines that can alter its exposure or increase adverse event risk.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nintedanib plasma levels, increasing toxicity.
• Potent P‑glycoprotein inhibitors (e.g., itraconazole): can elevate drug exposure and should be avoided.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk when combined with nintedanib.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may require dose adjustment and close monitoring.
• Antacids or proton pump inhibitors: may affect absorption; separate administration times are recommended.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): can reduce nintedanib effectiveness, monitor clinical response.