Europe — EMA
Nintedanib Teva
GNH USA supplies Nintedanib Teva (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 Teva, 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.
GNH USA supplies Nintedanib Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib is an antifibrotic agent indicated for progressive fibrotic lung disorders.
Idiopathic pulmonary fibrosis: slows the decline in forced vital capacity and reduces disease progression. Systemic sclerosis‑associated interstitial lung disease: limits worsening of lung fibrosis and improves functional outcomes. Other approved fibrotic lung conditions (where applicable): may be used under specialist supervision to manage disease progression.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, from mild to severe.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: sensation of unease or urge to vomit. - Vomiting: expulsion of stomach contents. - Abdominal pain: discomfort in the stomach area. - Decreased appetite: reduced desire to eat. - Elevated liver enzymes: increased ALT/AST levels.
Serious or Rare Side Effects: - Hepatic injury: potential liver dysfunction or failure. - Bleeding events: increased risk of gastrointestinal or other bleeding. - Cardiovascular events: such as myocardial infarction or stroke. - Severe infections: opportunistic or serious bacterial infections. - Gastrointestinal perforation: rare tearing of the GI tract. - Severe skin reactions: including Stevens‑Johnson syndrome or toxic epidermal necrolysis.
What precautions apply to Nintedanib?
Patients should be monitored for safety concerns before and during treatment.
Monitor liver function: obtain baseline and periodic ALT/AST measurements. Assess bleeding risk: evaluate concomitant anticoagulant or antiplatelet therapy. Evaluate cardiovascular status: watch for signs of ischemic events. Use caution in renal impairment: adjust monitoring if creatinine clearance is reduced. Avoid in pregnancy unless benefits outweigh risks: safety data are limited. Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk. - High‑dose aspirin or NSAIDs: additive bleeding potential.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise levels. - P‑gp inhibitors (e.g., verapamil): could increase systemic exposure. - Diuretics: monitor electrolytes and renal function. - Other antifibrotic agents: assess cumulative hepatic load.



