Europe — EMA
Nintedanib (Nintedanib Esylate)
GNH USA supplies Nintedanib (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung
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What is Nintedanib Esylate?
Nintedanib, the active ingredient in Nintedanib, is a tyrosine kinase inhibitor presented as an oral formulation for systemic use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and in combination with docetaxel for certain non‑small cell lung cancers.
GNH USA supplies Nintedanib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable global distribution, offering customers comprehensive regulatory support and timely delivery.
What is Nintedanib Esylate used for?
Nintedanib is used in fibrotic lung disorders and selected oncology regimens.
- Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: improves pulmonary function and delays worsening. - Non‑small cell lung cancer (in combination with docetaxel): enhances overall response rates and survival outcomes.
What are the side effects of Nintedanib Esylate?
Nintedanib may cause a range of adverse reactions, which are grouped by frequency and severity.
Common Side Effects: - Diarrhea: frequent loose stools, usually mild to moderate. - Nausea: feeling of sickness, often transient. - Decreased appetite: reduced desire to eat. - Vomiting: occasional episodes. - Abdominal pain: discomfort in the stomach area. - Elevated liver enzymes: mild increase in ALT/AST.
Serious or Rare Side Effects: - Hepatic failure: severe liver injury requiring close monitoring. - Gastrointestinal perforation: rare but potentially life‑threatening. - Severe bleeding: including pulmonary hemorrhage. - Cardiovascular events: such as myocardial infarction. - Serious infections: opportunistic infections in immunocompromised patients.
What precautions apply to Nintedanib Esylate?
When prescribing Nintedanib, clinicians should observe several precautionary measures.
- Liver function monitoring: assess ALT/AST before initiation and periodically during therapy. - Bleeding risk assessment: evaluate for anticoagulant use or history of hemorrhage. - Cardiovascular evaluation: consider baseline cardiac status in at‑risk patients. - Pregnancy and lactation: avoid use unless benefits outweigh potential risks. - Drug interaction review: check concomitant medications that affect CYP3A4. - Store at room temperature: keep in original container, protect from moisture and light.
What does Nintedanib Esylate interact with?
Nintedanib interacts with several medicines; awareness of the interaction level guides clinical decisions.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Anticoagulants (e.g., warfarin): heightened risk of bleeding.
Moderate Interactions (Monitor Closely): - Antiplatelet agents (e.g., aspirin, clopidogrel): monitor for bleeding signs. - P‑glycoprotein inhibitors (e.g., verapamil): may modestly raise plasma levels. - Other tyrosine kinase inhibitors: assess additive toxicity. - Diuretics: watch for electrolyte disturbances. - NSAIDs: increase gastrointestinal bleeding risk.



