Europe — EMA
Nintedanib Stada
GNH USA supplies Nintedanib Stada (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Stada, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It treats idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease in adult patients by blocking several growth‑factor receptors that drive fibroblast activity and extracellular matrix deposition, thereby helping to preserve lung function.
GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory support for cross‑border distribution.
What is Nintedanib used for?
Nintedanib is indicated for fibrotic lung diseases, where it targets pathways that lead to progressive scarring.
- Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function. - Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity and improves quality of life. - Progressive fibrosing interstitial lung disease: attenuates loss of lung capacity in patients with other fibrotic ILDs.
What are the side effects of Nintedanib?
Nintedanib may be associated with 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 unease or urge to vomit. - Vomiting: occasional expulsion of stomach contents. - Decreased appetite: reduced desire to eat.
Serious or Rare Side Effects: - Liver injury: elevated transaminases or hepatitis. - Bleeding events: gastrointestinal or other hemorrhage. - Gastrointestinal perforation: rare but potentially life‑threatening. - Severe hypersensitivity: rash, angioedema, or anaphylaxis.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should consider several safety measures.
- Liver function monitoring: perform baseline and periodic liver enzyme tests. - Bleeding risk assessment: avoid in patients with active bleeding or uncontrolled anticoagulation. - Cardiovascular evaluation: monitor for hypertension or ischemic events. - Renal impairment: adjust use in severe renal dysfunction. - Pregnancy and lactation: use only if benefits outweigh potential risks. - Store at below 25°C: keep in the original pack, protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with other medicines, requiring attention to the level of risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk. - High‑dose aspirin or NSAIDs: increased gastrointestinal bleeding.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - P‑gp inhibitors (e.g., verapamil): modestly raise plasma levels. - Diuretics (e.g., furosemide): may affect renal clearance.



