Europe — EMA
Nintedanib Stada
GNH USA supplies Nintedanib Stada (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 Stada, is a tyrosine kinase inhibitor presented as an oral dosage form for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain cases of non‑small cell lung cancer in adult patients, and is used under specialist supervision.
GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies, clinics and procurement teams worldwide.
What is Nintedanib used for?
Nintedanib is used to target fibrotic and oncogenic pathways 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 (selected patients): used in combination therapy to inhibit tumor growth and angiogenesis.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, varying from mild to severe.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may be transient. - Vomiting: occasional episodes. - Decreased appetite: reduced desire to eat. - Abdominal pain: discomfort in the stomach area. - Liver enzyme elevation: mild increase in ALT/AST.
Serious or Rare Side Effects: - Hepatotoxicity: significant liver injury, may require discontinuation. - Bleeding events: increased risk of gastrointestinal or other bleeding. - Cardiovascular events: rare cases of hypertension or arterial thromboembolism. - Severe infections: opportunistic infections in immunocompromised patients.
What precautions apply to Nintedanib?
When prescribing Nintedanib, clinicians should consider several safety precautions. - Liver function monitoring: assess baseline ALT/AST and repeat periodically. - Gastrointestinal management: advise patients to stay hydrated and report severe diarrhea. - Drug interactions: review concomitant medications that affect CYP3A4. - Pregnancy and lactation: avoid use unless benefits outweigh risks; limited data available. - Contraindications: do not use in patients with known hypersensitivity to nintedanib. - Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with other medicines, affecting its efficacy or safety.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin): heightened bleeding risk. - Antiplatelet agents (e.g., aspirin, clopidogrel): additive bleeding potential.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers (e.g., rifampicin): may reduce drug levels. - P‑glycoprotein inhibitors (e.g., verapamil): may modestly increase exposure. - NSAIDs: may exacerbate gastrointestinal side effects.



