Europe — EMA
Nintedanib
GNH USA supplies Nintedanib (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used with docetaxel for non‑small cell lung cancer. The drug is marketed in the European Union and is supplied under strict regulatory standards.
GNH USA supplies Nintedanib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib acts on fibrotic and oncologic pathways, providing therapeutic benefit in several serious lung conditions.
Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delay worsening. Non‑small cell lung cancer (in combination with docetaxel): improves overall survival when added to chemotherapy.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, from mild to serious. Patients should be informed of common and less frequent events.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: sensation of unease or urge to vomit. - Decreased appetite: reduced desire to eat. - Elevated liver enzymes: mild transaminase increases.
Serious or Rare Side Effects: - Hepatic failure: severe liver injury requiring monitoring. - Major bleeding: gastrointestinal or intracranial hemorrhage. - Cardiovascular events: myocardial infarction or ischemic heart disease. - Gastrointestinal perforation: rare but potentially life‑threatening. - Severe infections: opportunistic or bacterial infections. - Pneumothorax: collapsed lung, especially in advanced lung disease.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should consider several safety measures.
Monitor liver function: baseline and periodic tests due to risk of hepatotoxicity. Assess bleeding risk: avoid in patients with active hemorrhage or uncontrolled anticoagulation. Evaluate cardiovascular status: use cautiously in patients with ischemic heart disease. Pregnancy and breastfeeding: use only if benefits outweigh potential risks; data are limited. Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with other medicines, affecting its safety and efficacy.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors: may increase nintedanib exposure and toxicity. - Anticoagulants: additive risk of serious bleeding. - High‑dose aspirin: heightened gastrointestinal adverse effects.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers: may reduce therapeutic effect. - P‑glycoprotein inhibitors: could raise plasma concentrations. - Diuretics: monitor for dehydration and renal function changes.



