Nintedanib Teva (Nintedanib)

• Nintedanib is used to treat fibrotic lung diseases and certain cancers by targeting pathways that drive fibroblast activity and tumor angiogenesis.
• Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.
• Systemic sclerosis‑associated interstitial lung disease: improves pulmonary outcomes and delays worsening of lung capacity.
• Non‑small cell lung cancer (in specific settings): inhibits tumor growth and angiogenesis as part of combination therapy.

• Nintedanib blocks the intracellular ATP‑binding sites of multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR‑1,‑2,‑3), fibroblast growth factor receptors (FGFR‑1,‑2,‑3) and platelet‑derived growth factor receptors (PDGFR‑α,‑β). By inhibiting these pathways, it reduces endothelial cell proliferation, fibroblast activation, and extracellular matrix deposition, thereby limiting angiogenesis and fibrotic tissue formation in the lungs and other affected organs.

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

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness, may occur with or without vomiting.
• Abdominal pain: discomfort or cramps in the stomach area.
• Elevated liver enzymes: increase in ALT/AST detected in blood tests.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury, jaundice or hepatitis.
• Bleeding events: gastrointestinal or other bleeding, especially with anticoagulants.
• Cardiovascular events: arterial thromboembolism or myocardial infarction.

When prescribing Nintedanib, clinicians should consider several safety and handling precautions.

• Liver function monitoring: assess baseline ALT/AST and repeat regularly during therapy.
• Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea.
• Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors unless dose adjusted.
• Bleeding risk: evaluate bleeding history and use caution with anticoagulants or antiplatelet agents.
• Pregnancy and lactation: contraindicated or not recommended due to unknown fetal risk; avoid use in pregnant or nursing women.
• Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture and light.

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

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly increase exposure.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce effectiveness.
• Antifungal azoles and certain antibiotics: require monitoring of liver enzymes.