Europe — EMA
Nintedanib Stada Arzneimittel
GNH USA supplies Nintedanib Stada Arzneimittel (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Stada Arzneimittel, 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 non‑small cell lung cancer in adult patients.
GNH USA supplies Nintedanib Stada Arzneimittel as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib acts on pathways that drive fibrosis and tumor growth, 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 delays worsening. - Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea: frequent, watery stools often occurring early in therapy. - Nausea and vomiting: mild to moderate gastrointestinal discomfort. - Abdominal pain: cramping or discomfort in the stomach area. - Decreased appetite: reduced desire to eat, sometimes leading to weight loss. - Elevated liver enzymes: mild increases in ALT/AST observed in routine labs.
Serious or Rare Side Effects: - Severe liver injury: rare cases of hepatitis or hepatic failure. - Major bleeding events: gastrointestinal or intracranial hemorrhage, especially with anticoagulants. - Cardiovascular complications: hypertension, arterial thromboembolism. - Gastrointestinal perforation: rare but potentially life‑threatening ulceration.
What precautions apply to Nintedanib?
Before initiating Nintedanib, clinicians should assess patient risk factors and monitor key parameters throughout treatment. - Liver function monitoring: assess ALT/AST before start and regularly during therapy. - Bleeding risk: evaluate concomitant anticoagulant or antiplatelet use and adjust as needed. - Cardiovascular assessment: monitor blood pressure and cardiac status, especially in patients with pre‑existing disease. - Pregnancy and lactation: safety not established; avoid use in pregnant or nursing women. - Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original packaging.
What does Nintedanib interact with?
Nintedanib can interact with other medicines that affect its metabolism or increase bleeding risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase nintedanib exposure. - Strong CYP3A4 inducers (e.g., rifampicin): may reduce nintedanib exposure. - Anticoagulants (e.g., warfarin): heightened risk of serious bleeding. - Antiplatelet agents (e.g., aspirin, clopidogrel): increased hemorrhage potential.
Moderate Interactions (Monitor Closely): - P‑gp inhibitors (e.g., verapamil): may moderately raise plasma levels. - BCRP inhibitors (e.g., elacridar): may modestly increase exposure. - Diuretics: monitor electrolytes and renal function when combined.



