Nintedanib (Nintedanib Esylate)

Nintedanib, the active ingredient in Nintedanib, is a tyrosine kinase inhibitor presented as a capsule for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used in combination therapy for non‑small cell lung cancer in appropriate patients.

GNH USA supplies Nintedanib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide.

Nintedanib is indicated for fibrotic lung diseases and as part of combination therapy for certain lung cancers. - Idiopathic pulmonary fibrosis (IPF): slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease (SSc‑ILD): improves forced vital capacity and delays worsening. - Non‑small cell lung cancer (NSCLC) in combination with docetaxel: enhances overall survival and response rates in previously treated patients.

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

Common Side Effects: - Diarrhea: frequent, may be mild to moderate. - Nausea: occasional gastrointestinal upset. - Vomiting: occasional. - Elevated liver enzymes (ALT/AST): mild elevations.

Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury requiring monitoring. - Bleeding events: increased risk of hemorrhage, especially with anticoagulants. - Cardiovascular events: rare cases of myocardial infarction or arterial thromboembolism.

Before initiating therapy, clinicians should consider several safety measures. - Liver function monitoring: assess ALT/AST before treatment and periodically during therapy. - Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea. - Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors without dose adjustment. - Pregnancy risk: contraindicated in pregnancy; ensure effective contraception. - Bleeding risk: assess bleeding history and avoid use with anticoagulants unless necessary. - Store at ambient temperature: keep capsules below 25°C in original packaging, protect from moisture.

Nintedanib has notable interactions that require attention.

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

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers (e.g., rifampicin): may reduce efficacy. - Antiplatelet agents (e.g., aspirin, clopidogrel): monitor for bleeding. - NSAIDs: increase gastrointestinal adverse events.