Europe — EMA
Nintedanib Accordpharma (Nintedanib Esylate)
GNH USA supplies Nintedanib Accordpharma (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated ILD
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What is Nintedanib Esylate?
Nintedanib, the active ingredient in Nintedanib Accordpharma, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain cases of non‑small cell lung cancer.
GNH USA supplies Nintedanib Accordpharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide. The product conforms to EU market standards and is available for export.
What is Nintedanib Esylate used for?
Nintedanib is used in fibrotic lung disorders and selected oncologic settings, targeting disease pathways driven by vascular and growth factor signaling.
- Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression. - Systemic sclerosis‑associated interstitial lung disease: improves pulmonary capacity and delays worsening. - Non‑small cell lung cancer: used in combination therapy to inhibit tumor angiogenesis and growth.
What are the side effects of Nintedanib Esylate?
Nintedanib may be associated with a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may occur with meals. - Vomiting: occasional episodes, usually self‑limiting. - Elevated liver enzymes: mild increases in ALT/AST observed in monitoring.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury requiring discontinuation. - Bleeding events: gastrointestinal or other hemorrhage, especially with anticoagulants. - Cardiovascular events: arterial thromboembolism or myocardial infarction.
What precautions apply to Nintedanib Esylate?
When prescribing Nintedanib, clinicians should consider several precautionary measures to ensure patient safety. - Liver function monitoring: assess baseline ALT/AST and repeat regularly. - Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea. - Drug interactions: avoid concurrent use with strong CYP3A4 inhibitors unless benefits outweigh risks. - Bleeding risk: evaluate coagulation status and use caution with anticoagulants. - Pregnancy and lactation: contraindicated unless potential benefit justifies potential risk; discuss with specialist. - Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture and light.
What does Nintedanib Esylate interact with?
Nintedanib can interact with other medicines, altering its efficacy or safety profile.
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 concentrations.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise levels. - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce effectiveness. - Antiplatelet agents (e.g., aspirin, clopidogrel): monitor for signs of bleeding.



