Nintedanib Zentiva (Nintedanib Esylate)

Nintedanib is used to target fibrotic lung diseases and certain cancers by inhibiting key growth factor receptors.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening.
• Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth.

• Nintedanib blocks the intracellular tyrosine kinase activity of multiple receptors including vascular endothelial growth factor receptors (VEGFR 1‑3), fibroblast growth factor receptors (FGFR 1‑3) and platelet‑derived growth factor receptors (PDGFR‑α/β). By preventing autophosphorylation, it reduces downstream signaling that drives endothelial cell proliferation, fibroblast activation, angiogenesis and extracellular matrix deposition, thereby limiting fibrotic remodeling and tumor angiogenesis.

Nintedanib may be associated with 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 occur with or without vomiting.
• Vomiting: occasional episodes, usually self‑limiting.
• Elevated liver enzymes: increases in ALT/AST observed in laboratory tests.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury, jaundice or hepatic failure.
• Cardiovascular events: arterial thromboembolism or myocardial infarction.
• Severe gastrointestinal perforation: rare but potentially life‑threatening.

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

• Liver function monitoring: assess baseline ALT/AST and repeat periodically.
• Gastrointestinal assessment: evaluate for pre‑existing conditions that may worsen diarrhea.
• Bleeding risk: avoid in patients with uncontrolled bleeding or on strong anticoagulants.
• Cardiovascular evaluation: monitor for signs of ischemic events, especially in high‑risk patients.
• Pregnancy and lactation: contraindicated or use only if benefit outweighs risk (unknown category).
• Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and light.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors: may increase nintedanib exposure, raising toxicity risk.
• Anticoagulants (e.g., warfarin): combined use may enhance bleeding risk.
• P‑glycoprotein inhibitors: can raise plasma concentrations.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inducers: may reduce effectiveness.
• Antacids containing magnesium/aluminum: may affect absorption if taken simultaneously.
• Diuretics: monitor for dehydration which can exacerbate renal side effects.