Nintedanib Zentiva (Nintedanib Esylate)

Nintedanib is an antifibrotic agent that targets pathways involved in lung tissue scarring.

• Idiopathic pulmonary fibrosis (IPF): slows disease progression and reduces decline in lung function.
• Systemic sclerosis‑associated interstitial lung disease (SSc‑ILD): helps preserve lung capacity and delays worsening.
• Non‑small cell lung cancer (NSCLC) in combination therapy: contributes to tumor control when used with other anticancer agents.

• Nintedanib inhibits multiple 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, migration, and transformation, thereby attenuating pathological tissue remodeling and fibrotic processes in the lung and other affected organs.

Adverse reactions may occur with Nintedanib therapy.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: sensation of queasiness, may affect appetite.
• Vomiting: occasional expulsion of stomach contents.
• Abdominal pain: discomfort or cramps in the stomach area.
• Decreased appetite: reduced desire to eat, potentially leading to weight loss.
• Weight loss: unintended reduction in body weight.

Serious or Rare Side Effects

• Elevated liver enzymes: indicates potential hepatic injury.
• Bleeding events: increased risk of gastrointestinal or other bleeding.
• Cardiovascular complications: such as myocardial infarction or arterial thromboembolism.
• Severe infections: opportunistic infections in immunocompromised patients.
• Pulmonary hypertension: rare worsening of pulmonary vascular pressure.

Before initiating therapy, several safety considerations should be reviewed.

• Liver function monitoring: assess baseline enzymes and repeat periodically.
• Bleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use.
• Cardiovascular evaluation: screen for history of ischemic heart disease or thromboembolic events.
• Pregnancy and lactation: avoid use unless benefits outweigh potential risks, as safety is unknown.
• Drug-specific contraindications: do not use in patients with severe hepatic impairment or known hypersensitivity.
• Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Nintedanib may interact with other medicines, requiring attention to the interaction strength.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
• Potent P‑gp inhibitors (e.g., verapamil, quinidine): can raise plasma concentrations.
• High‑dose anticoagulants (e.g., warfarin, direct oral anticoagulants): elevate bleeding risk.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A4 inhibitors or inducers (e.g., fluconazole, rifampicin): may alter drug levels.
• Antacids or proton‑pump inhibitors: could affect gastrointestinal absorption.
• CYP2C8 substrates (e.g., rosiglitazone): monitor for potential pharmacokinetic changes.