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 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, and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncologic pathways. - Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression. - Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and stabilises respiratory status. - Non‑small cell lung cancer: used in combination therapy to inhibit tumor angiogenesis and growth.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions.
Common Side Effects: - Diarrhoea: frequent loose stools, often mild to moderate. - Nausea: sensation of unease in the stomach. - Vomiting: expulsion of stomach contents. - Decreased appetite: reduced desire to eat. - Elevated liver enzymes: increased ALT/AST levels. - Fatigue: feeling of tiredness or lack of energy.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, jaundice, or hepatitis. - Bleeding events: gastrointestinal or other serious haemorrhage. - Cardiovascular events: arterial thromboembolism or myocardial infarction. - Severe infections: opportunistic or bacterial infections. - Interstitial lung disease worsening: acute respiratory decline. - Allergic reactions: rash, urticaria, or anaphylaxis.
What precautions apply to Nintedanib?
Before initiating Nintedanib, consider the following safety measures. - Liver function monitoring: check ALT, AST, and bilirubin regularly. - Gastrointestinal assessment: manage diarrhoea promptly to avoid dehydration. - Bleeding risk evaluation: avoid concomitant anticoagulants unless essential. - Cardiovascular review: assess history of arterial events. - Pregnancy and lactation: avoid use; discuss alternatives with a specialist. - Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and light.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase plasma concentrations. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - P‑glycoprotein substrates (e.g., digoxin): possible altered exposure. - NSAIDs and antiplatelet agents: additive bleeding potential.



