Europe — EMA
Nintedanib Stada
GNH USA supplies Nintedanib Stada (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and non‑small cell lung cancer.
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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 and certain forms of lung cancer in adult patients.
GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib acts on pathways involved in fibroblast activity and tumor angiogenesis, making it useful for fibrotic lung disease and certain cancers. - Idiopathic pulmonary fibrosis: slows decline in lung function and disease progression. - Non‑small cell lung cancer: used in combination regimens to inhibit tumor growth. - Systemic sclerosis‑associated interstitial lung disease: reduces rate of forced vital capacity loss.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, from mild to serious.
Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Diarrhea: frequent loose stools, often requiring supportive care. - Vomiting: occasional episodes, usually early in therapy. - Abdominal pain: crampy discomfort in the upper abdomen. - Decreased appetite: reduced food intake leading to weight loss. - Headache: transient mild to moderate head pain.
Serious or Rare Side Effects: - Elevated liver enzymes: may indicate hepatic injury. - Bleeding events: increased risk of gastrointestinal or other hemorrhage. - Cardiovascular events: rare cases of myocardial infarction or stroke. - Severe infections: opportunistic infections in immunocompromised patients. - Gastrointestinal perforation: rare but life‑threatening condition. - Severe skin reactions: such as Stevens‑Johnson syndrome.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should evaluate several safety aspects. - Liver function monitoring: check ALT/AST levels regularly. - Bleeding risk assessment: avoid in patients with active ulcers or anticoagulant therapy. - Cardiovascular evaluation: caution in patients with recent cardiac events. - Gastrointestinal history: monitor for severe diarrhea or abdominal pain. - Hepatic impairment: avoid or adjust dose in severe liver disease. - Store at ambient temperature: keep in the original container, protect from moisture and light.
What does Nintedanib interact with?
Nintedanib can interact with other medicines, requiring careful management.
Major Interactions (Avoid): - Strong P‑gp inhibitors (e.g., ketoconazole): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin): heightened bleeding risk. - High‑dose aspirin or NSAIDs: additive bleeding potential.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise levels. - CYP3A4 inducers (e.g., rifampicin): may reduce efficacy. - Diuretics: monitor electrolytes and renal function. - Antacids containing aluminum or magnesium: may affect absorption if taken simultaneously.



