Europe — EMA
Nintedanib Teva B.V.
GNH USA supplies Nintedanib Teva B.V. (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Teva B.V., 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 is used in combination therapy for non‑small cell lung cancer.
GNH USA supplies Nintedanib Teva B.V. as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib acts on multiple fibrotic and oncogenic pathways, providing therapeutic benefit in several lung‑related 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 therapy): contributes to tumor growth inhibition when used with other anticancer agents.
What are the side effects of Nintedanib?
Nintedanib is associated with a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea - Nausea - Vomiting - Abdominal pain - Decreased appetite - Elevated liver enzymes (ALT/AST)
Serious or Rare Side Effects: - Hepatic failure or severe liver injury - Arterial thromboembolic events (e.g., myocardial infarction, stroke) - Severe bleeding or hemorrhage - Gastrointestinal perforation - Severe hypertension - Exacerbation of interstitial lung disease
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should evaluate several safety parameters.
Monitor liver function: perform baseline and periodic hepatic enzyme tests. Assess cardiovascular risk: review history of thromboembolic disease. Evaluate bleeding risk: avoid concurrent use with strong anticoagulants unless necessary. Use caution in renal impairment: adjust monitoring for patients with reduced kidney function. Pregnancy and lactation: avoid use as safety data are lacking. Store at below 25°C: keep in the original packaging, protect from moisture and light.
What does Nintedanib interact with?
Nintedanib may interact with drugs that affect its metabolism or increase bleeding risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) - Anticoagulants (e.g., warfarin, direct oral anticoagulants) - Antiplatelet agents (e.g., clopidogrel, high‑dose aspirin) - Concurrent use with other tyrosine‑kinase inhibitors - High‑dose aspirin (>100 mg daily)
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole) - P‑gp inhibitors (e.g., verapamil) - Diuretics (may increase risk of dehydration) - Non‑steroidal anti‑inflammatory drugs (NSAIDs) - CYP3A4 inducers (e.g., rifampicin) which may reduce exposure



