Nintedanib Zentiva (Nintedanib Esylate)

Nintedanib acts on multiple fibrotic and oncologic pathways, providing therapeutic benefit in several lung‑related disease groups.

• Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity in affected patients.
• Non‑small cell lung cancer (in combination with chemotherapy): enhances treatment response when used with standard chemotherapy regimens.

• Nintedanib inhibits several receptor tyrosine kinases, 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 blocking these pathways, it reduces fibroblast proliferation, angiogenesis, and extracellular matrix deposition, thereby attenuating fibrotic remodeling and tumor‑related vascular growth.

Nintedanib may cause a range of adverse reactions, from mild to severe. Patients should be aware of both common and less frequent events.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: sensation of queasiness, may occur with or without vomiting.
• Decreased appetite: reduced desire to eat, potentially leading to weight loss.
• Elevated liver enzymes: increased ALT/AST levels detected on laboratory testing.

Serious or Rare Side Effects

• Hepatotoxicity: severe liver injury requiring discontinuation.
• Bleeding events: gastrointestinal or other bleeding, especially with anticoagulants.
• Cardiovascular events: hypertension or arterial thrombotic episodes.
• Severe infections: opportunistic infections in immunocompromised patients.

Before initiating therapy, clinicians should evaluate several safety considerations.

• Dose adjustment: assess renal or hepatic impairment and modify dose accordingly.
• Bleeding risk: monitor patients receiving anticoagulants or antiplatelet agents.
• Cardiovascular monitoring: check blood pressure and watch for signs of hypertension.
• Liver function: obtain baseline tests and repeat periodically during treatment.
• Pregnancy: avoid use as safety in pregnancy and lactation is unknown.
• Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

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

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors: may increase nintedanib exposure and toxicity.
• Anticoagulants: concurrent use can heighten bleeding risk.
• Other tyrosine kinase inhibitors: combined use may amplify adverse effects.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inducers: may reduce nintedanib plasma levels and effectiveness.
• P‑glycoprotein inhibitors: can raise plasma concentrations, requiring observation.
• Diuretics: monitor for dehydration and renal function changes.