Europe — EMA
Nintedanib Stada
GNH USA supplies Nintedanib Stada (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 Stada, is a tyrosine kinase inhibitor presented as a tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease in adult patients. GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib is an antifibrotic agent that targets progressive fibrotic lung disorders.
Idiopathic pulmonary fibrosis: slows the decline in forced vital capacity and improves survival. Systemic sclerosis‑associated interstitial lung disease: reduces the rate of lung function deterioration. Progressive fibrosing interstitial lung disease (non‑IPF): attenuates disease progression in patients with a fibrotic phenotype.
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: frequent, often mild to moderate. - Nausea: may occur after dosing. - Vomiting: occasional, usually self‑limiting. - Abdominal pain: mild discomfort reported. - Decreased appetite: reduced food intake. - Weight loss: modest, related to gastrointestinal effects.
Serious or Rare Side Effects: - Elevated liver enzymes (ALT/AST): may indicate hepatic injury. - Bleeding events: increased risk of gastrointestinal or other hemorrhage. - Cardiovascular events: such as myocardial infarction or stroke. - Severe infections: opportunistic infections reported. - Gastrointestinal perforation: rare but serious complication. - Worsening of interstitial lung disease: rare progression despite therapy.
What precautions apply to Nintedanib?
When prescribing Nintedanib, clinicians should consider several safety measures.
Monitor liver function: check ALT/AST before initiation and periodically thereafter. Assess bleeding risk: avoid in patients with active ulcers or on strong anticoagulants. Evaluate cardiovascular status: caution in patients with recent myocardial infarction or stroke. Counsel on gastrointestinal symptoms: advise patients to report persistent diarrhea or abdominal pain. Avoid use in severe hepatic impairment: contraindicated in patients with Child‑Pugh C. Store at below 25°C: keep in the original pack, protect from moisture.
What does Nintedanib interact with?
Nintedanib may interact with other medicines that affect its metabolism or increase bleeding risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma levels. - Potent P‑glycoprotein inhibitors (e.g., itraconazole): can increase exposure. - Anticoagulants (e.g., warfarin) at high doses: heightened bleeding risk.
Moderate Interactions (Monitor Closely):\n- Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly increase concentrations. - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Non‑steroidal anti‑inflammatory drugs (NSAIDs): monitor for gastrointestinal bleeding.



