Europe — EMA
Nintedanib Stada
GNH USA supplies Nintedanib Stada (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated ILD
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Stada, is a tyrosine kinase inhibitor presented as a tablet 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 Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib is used to treat fibrotic lung conditions and certain cancers by targeting pathways that drive fibroblast proliferation and angiogenesis.
- Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening. - Non‑small cell lung cancer (in combination therapy): inhibits tumor growth and angiogenesis.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, which are generally categorized by frequency and severity.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may affect appetite. - Vomiting: occasional episodes, usually self‑limiting. - Elevated liver enzymes: increased ALT/AST levels detected in blood tests.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, jaundice, or hepatitis. - Bleeding events: gastrointestinal or pulmonary hemorrhage. - Cardiovascular events: arterial thromboembolism or myocardial infarction.
What precautions apply to Nintedanib?
Before prescribing Nintedanib, clinicians should consider several precautionary measures to ensure patient safety.
- Liver function monitoring: assess baseline ALT/AST and repeat regularly. - Gastrointestinal assessment: evaluate history of severe diarrhea or ulcerative colitis. - Cardiovascular risk: review for recent arterial thrombotic events. - Drug interactions: avoid concurrent use with strong CYP3A4 inhibitors. - Pregnancy and breastfeeding: use only if clearly needed; safety not established. - Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with other medicines, affecting its concentration or increasing toxicity.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise levels. - P‑glycoprotein substrates (e.g., digoxin): potential altered plasma concentrations. - CYP1A2 inducers (e.g., smoking): may reduce efficacy.



