Europe — EMA
Nintedanib Accordpharma
GNH USA supplies Nintedanib Accordpharma (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Accordpharma, is a tyrosine kinase inhibitor presented as an oral dosage form for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in appropriate patients.
GNH USA supplies Nintedanib Accordpharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, transplant centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib is indicated for fibrotic lung diseases and certain cancers, acting on pathways that drive fibroblast activity and tumor growth.
- Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function. - Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity. - Non‑small cell lung cancer (in combination therapy): improves progression‑free survival in eligible patients.
What are the side effects of Nintedanib?
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, often transient. - Vomiting: occasional. - Elevated liver enzymes (ALT/AST): observed in routine monitoring.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, requires monitoring. - Bleeding events: increased risk of gastrointestinal or pulmonary hemorrhage. - Cardiovascular events: arterial thrombotic events such as myocardial infarction.
What precautions apply to Nintedanib?
When prescribing Nintedanib, clinicians should consider several safety measures.
- Liver function monitoring: assess ALT, AST and bilirubin before and during therapy. - Gastrointestinal management: treat diarrhea promptly to avoid dehydration. - Cardiovascular assessment: evaluate history of arterial thrombotic disease before initiating. - Drug interactions: review concomitant medications that affect CYP3A4. - Pregnancy and lactation: avoid use; safety not established. - Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and light.
What does Nintedanib interact with?
Nintedanib interacts with several drug classes; awareness helps minimise risk.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): increased bleeding risk. - Potent CYP3A4 inhibitors (e.g., ketoconazole): may raise exposure, caution advised.
Moderate Interactions (Monitor Closely): - P‑glycoprotein inhibitors (e.g., verapamil): may increase plasma levels. - NSAIDs or aspirin: additive risk of gastrointestinal bleeding. - Diuretics: monitor for dehydration if severe diarrhea occurs.



