Nintedanib Zentiva (Nintedanib Esylate)

• Nintedanib Zentiva acts on pathways involved in fibrosis and tumor angiogenesis, providing therapeutic benefit in specific pulmonary and oncologic conditions.
• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Non‑small cell lung cancer: used with chemotherapy to improve progression‑free survival in adults with adenocarcinoma histology.

• 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, angiogenesis, and the fibrotic remodeling that underlies idiopathic pulmonary fibrosis and supports tumor growth in non‑small cell lung cancer.

Adverse reactions may vary in frequency and severity.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of sickness, may be accompanied by loss of appetite.
• Vomiting: occasional episodes, usually self‑limiting.
• Decreased appetite: reduced desire to eat, potentially leading to weight loss.
• Elevated liver enzymes: mild increases in ALT/AST observed in routine monitoring.

Serious or Rare Side Effects

• Hepatic failure: signs of severe liver injury requiring immediate medical attention.
• Severe bleeding: gastrointestinal or intracranial hemorrhage, especially with anticoagulants.
• Cardiovascular events: myocardial infarction or arterial thrombosis.
• Gastrointestinal perforation: rare but life‑threatening condition.
• Severe infection or pneumonitis: may present with fever, cough, and respiratory distress.

• Before initiating therapy, clinicians should assess baseline organ function and risk factors.
• Monitor liver function: perform baseline and periodic ALT/AST testing.
• Assess cardiovascular risk: evaluate blood pressure and cardiac history.
• Evaluate bleeding risk: avoid concomitant use of strong anticoagulants when possible.
• Pregnancy and lactation: avoid use; safety has not been established.
• Store at ambient temperature: keep below 25 °C, retain in original packaging, and protect from moisture.

Nintedanib may interact with other medicines that affect its metabolism or increase bleeding risk.

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
• NSAIDs or antiplatelet agents: monitor for signs of bleeding.
• St. John's wort: may lower drug levels, requiring clinical observation.