Europe — EMA
Nintedanib Zentiva (Nintedanib Esylate)
GNH USA supplies Nintedanib Zentiva (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial
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What is Nintedanib Esylate?
Nintedanib, the active ingredient in Nintedanib Zentiva, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain forms of non‑small cell lung cancer in adult patients. The product is authorized in the European Union and manufactured under stringent quality standards.
GNH USA supplies Nintedanib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics, ensuring consistent quality and regulatory compliance across regions worldwide.
What is Nintedanib Esylate used for?
Nintedanib is used to target fibrotic lung diseases and certain cancers by inhibiting key growth factor receptors. - 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: used in combination therapy to inhibit tumor growth.
What are the side effects of Nintedanib Esylate?
Nintedanib may be associated with a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may occur with or without vomiting. - Vomiting: occasional episodes, usually self‑limiting. - Elevated liver enzymes: increases in ALT/AST observed in laboratory tests.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, jaundice or hepatic failure. - Cardiovascular events: arterial thromboembolism or myocardial infarction. - Severe gastrointestinal perforation: rare but potentially life‑threatening.
What precautions apply to Nintedanib Esylate?
When prescribing Nintedanib, clinicians should consider several safety and handling precautions. - Liver function monitoring: assess baseline ALT/AST and repeat periodically. - Gastrointestinal assessment: evaluate for pre‑existing conditions that may worsen diarrhea. - Bleeding risk: avoid in patients with uncontrolled bleeding or on strong anticoagulants. - Cardiovascular evaluation: monitor for signs of ischemic events, especially in high‑risk patients. - Pregnancy and lactation: contraindicated or use only if benefit outweighs risk (unknown category). - Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and light.
What does Nintedanib Esylate interact with?
Nintedanib can interact with other medicines, affecting its efficacy or safety.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors: may increase nintedanib exposure, raising toxicity risk. - Anticoagulants (e.g., warfarin): combined use may enhance bleeding risk. - P‑glycoprotein inhibitors: can raise plasma concentrations.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers: may reduce effectiveness. - Antacids containing magnesium/aluminum: may affect absorption if taken simultaneously. - Diuretics: monitor for dehydration which can exacerbate renal side effects.



