Europe — EMA
Nintedanib 1a Pharma (Nintedanib Esylate)
GNH USA supplies Nintedanib 1a Pharma (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 1a Pharma, is a tyrosine kinase inhibitor presented as a oral 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 1a Pharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide.
What is Nintedanib Esylate used for?
Nintedanib is indicated for fibrotic lung conditions and as part of combination therapy for certain lung cancers. - Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and stabilizes lung involvement. - Non‑small cell lung cancer (in combination therapy): enhances treatment efficacy when used with chemotherapy agents.
What are the side effects of Nintedanib Esylate?
Nintedanib may cause 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 be transient. - Vomiting: occasional episodes, usually self‑limiting. - Elevated liver enzymes: mild increases in ALT/AST.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, requires monitoring. - Cardiovascular events: arterial thromboembolism or myocardial infarction. - Severe bleeding: gastrointestinal or other major hemorrhage.
What precautions apply to Nintedanib Esylate?
When prescribing Nintedanib, clinicians should consider several safety and handling precautions. - Liver function monitoring: assess ALT, AST, bilirubin before and during therapy. - Gastrointestinal assessment: monitor for persistent diarrhea or vomiting. - Cardiovascular risk: evaluate history of arterial thromboembolism. - Pregnancy and lactation: avoid use due to unknown safety; contraindicated in pregnancy. - Drug interactions: review concomitant medications that affect CYP3A4. - Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.
What does Nintedanib Esylate interact with?
Nintedanib can interact with other medicines, influencing its efficacy or safety.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may markedly reduce plasma levels. - Anticoagulants (warfarin, direct oral anticoagulants): increased bleeding risk. - Antiplatelet agents (aspirin, clopidogrel): heightened hemorrhage potential.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may raise exposure. - P-glycoprotein inhibitors (e.g., verapamil): possible increase in concentration. - Diuretics: monitor for dehydration if severe diarrhea occurs.



