Europe — EMA
Nintedanib Zentiva (Nintedanib Esylate)
GNH USA supplies Nintedanib Zentiva (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial
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What is Nintedanib Esylate?
Nintedanib, the active ingredient in Nintedanib Zentiva, is a tyrosine kinase inhibitor presented as a capsule for oral use. It is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer in adult patients.
GNH USA supplies Nintedanib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Nintedanib Esylate used for?
Nintedanib targets fibrotic lung disease and certain cancers by inhibiting multiple growth‑factor receptors.
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 therapy): contributes to tumor control when used with chemotherapy.
What are the side effects of Nintedanib Esylate?
Nintedanib may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea: often mild to moderate, may require supportive care. - Nausea and vomiting: usually transient. - Abdominal pain or discomfort. - Decreased appetite and weight loss. - Elevated liver enzymes (ALT, AST). - Headache.
Serious or Rare Side Effects: - Severe liver injury or hepatitis. - Gastrointestinal perforation. - Significant bleeding events. - Cardiovascular complications such as myocardial infarction. - Severe infections. - Pulmonary embolism.
What precautions apply to Nintedanib Esylate?
Before initiating therapy, clinicians should assess baseline organ function and consider potential risks. - Liver function monitoring: obtain baseline tests and repeat periodically. - Bleeding risk: evaluate concomitant anticoagulant or antiplatelet use. - Gastrointestinal tolerance: monitor for severe or persistent diarrhea. - Pregnancy and lactation: use only if potential benefit justifies potential risk. - Drug interactions: review all concomitant medications for CYP3A4 or P‑gp effects. - Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.
What does Nintedanib Esylate interact with?
Nintedanib interacts with several drug classes that can alter its exposure or increase adverse events.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): may increase nintedanib levels. - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin): may reduce efficacy. - Potent P‑gp inhibitors (e.g., verapamil): can raise systemic exposure. - Anticoagulants/antiplatelet agents: heightened bleeding risk. - High‑dose aspirin: may exacerbate gastrointestinal toxicity.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin): may modestly increase exposure. - Antacids or proton‑pump inhibitors: could affect absorption; separate dosing by at least 2 hours. - NSAIDs: monitor for additive gastrointestinal bleeding. - Herbal supplements affecting CYP enzymes (e.g., St John's wort): may lower drug levels. - Diuretics: watch for electrolyte disturbances if severe diarrhea occurs.



