Europe — EMA
Nintedanib Zentiva (Nintedanib Esylate)
GNH USA supplies Nintedanib Zentiva (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and non‑small cell lung cancer.
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What is Nintedanib Esylate?
Nintedanib, the active ingredient in Nintedanib Zentiva, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and certain forms of lung cancer in adult patients. GNH USA supplies Nintedanib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib Esylate used for?
Nintedanib acts on pathways involved in fibrotic lung disease and tumor angiogenesis. - Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in forced vital capacity. - Non‑small cell lung cancer: used in combination regimens to inhibit tumor growth and angiogenesis. - Progressive fibrosing interstitial lung disease: diminishes the rate of lung function loss in patients with a progressive fibrotic phenotype.
What are the side effects of Nintedanib Esylate?
Nintedanib may cause a range of adverse reactions.
Common Side Effects: - Diarrhea: frequent, watery stools that may require supportive care. - Nausea: sensation of unease often accompanied by an urge to vomit. - Decreased appetite: reduced desire to eat, potentially leading to weight loss. - Elevated liver enzymes: increases in ALT/AST observed in routine monitoring.
Serious or Rare Side Effects: - Hepatic failure: severe liver injury requiring immediate medical attention. - Major bleeding: gastrointestinal or intracranial hemorrhage, especially when combined with anticoagulants. - Arterial thromboembolism: clot formation in arteries that can cause stroke or myocardial infarction.
What precautions apply to Nintedanib Esylate?
Before initiating therapy, clinicians should consider several safety measures. - Liver function monitoring: assess baseline enzymes and repeat periodically. - Cardiovascular assessment: evaluate for hypertension or history of thrombotic events. - Bleeding risk evaluation: avoid concomitant use with strong anticoagulants unless necessary. - Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited. - Storage: Store at room temperature: keep in the original container, protect from moisture and direct sunlight.
What does Nintedanib Esylate interact with?
Nintedanib can interact with other medicines, requiring careful management.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of serious bleeding. - Antiplatelet agents (e.g., clopidogrel, high‑dose aspirin): additive bleeding potential.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce therapeutic levels. - Calcium channel blockers (e.g., amlodipine): may modestly increase plasma concentrations. - Statins (e.g., simvastatin, atorvastatin): monitor for liver enzyme changes.



