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 formulation for systemic 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 in adult patients.
GNH USA supplies Nintedanib Accordpharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches for clinical use under medical supervision.
What is Nintedanib used for?
Nintedanib is used to treat fibrotic lung diseases and certain cancers by targeting pathways involved in fibroblast activation and tumor angiogenesis.
- Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: improves pulmonary outcomes and stabilizes fibrosis. - Non‑small cell lung cancer (in specific settings): inhibits tumor growth and angiogenesis as part of combination therapy.
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 loose stools, often mild to moderate. - Nausea: feeling of sickness or urge to vomit. - Abdominal pain: discomfort or cramps in the stomach area. - Elevated liver enzymes: increased ALT/AST levels detected in blood tests.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, potentially leading to jaundice. - Bleeding events: gastrointestinal or other bleeding, especially with anticoagulants. - Cardiovascular events: arterial thromboembolism or myocardial infarction.
What precautions apply to Nintedanib?
When prescribing Nintedanib, clinicians should consider several precautionary measures to ensure patient safety.
- Liver function monitoring: assess ALT/AST before treatment and periodically during therapy. - Gastrointestinal management: advise patients on hydration and antidiarrheal measures. - Drug interactions: review concomitant use of strong CYP3A4 inhibitors or inducers. - Bleeding risk: evaluate history of bleeding disorders or use of anticoagulants. - Pregnancy and lactation: avoid use due to unknown safety; discuss contraception. - Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture and light.
What does Nintedanib 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 plasma levels, raising toxicity risk. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce drug exposure, decreasing effectiveness. - P‑glycoprotein substrates (e.g., digoxin): potential for altered concentrations. - NSAIDs or aspirin: may exacerbate gastrointestinal bleeding.



