Europe — EMA
Nintedanib Zentiva (Nintedanib Esylate)
GNH USA supplies Nintedanib Zentiva (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and systemic sclerosis‑associated ILD.
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What is Nintedanib Esylate?
Nintedanib Esylate, the active ingredient in Nintedanib Zentiva, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease in adult patients, offering a therapeutic option for progressive fibrotic lung disease. The medication is indicated for patients with declining lung function despite standard care.
GNH USA supplies Nintedanib Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑compliant shipments to meet global demand.
What is Nintedanib Esylate used for?
Nintedanib Zentiva is used to target fibrotic lung disease pathways, primarily in conditions characterized by progressive scarring.
- Idiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression. - Systemic sclerosis‑associated interstitial lung disease: improves forced vital capacity and delays respiratory deterioration.
What are the side effects of Nintedanib Esylate?
Nintedanib Zentiva 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 meals. - Vomiting: occasional episodes. - Abdominal pain: discomfort in the stomach area. - Decreased appetite: reduced desire to eat. - Weight loss: unintended loss of body weight.
Serious or Rare Side Effects: - Elevated liver enzymes: potential hepatotoxicity requiring monitoring. - Bleeding events: increased risk of gastrointestinal or other bleeding. - Cardiovascular events: rare cases of myocardial infarction or stroke. - Severe infections: opportunistic infections in immunocompromised patients. - Gastrointestinal perforation: rare but serious intestinal injury.
What precautions apply to Nintedanib Esylate?
When prescribing Nintedanib Zentiva, clinicians should observe several precautionary measures to ensure patient safety.
- Monitor liver function: perform baseline and periodic ALT/AST tests. - Assess bleeding risk: evaluate concomitant anticoagulant use and history of ulcers. - Evaluate cardiovascular status: be cautious in patients with recent myocardial infarction or uncontrolled hypertension. - Avoid in severe hepatic impairment: contraindicated in patients with Child‑Pugh C liver disease. - Pregnancy and lactation: use only if potential benefit outweighs risk, as safety data are limited. - Store at below 25°C: keep in the original packaging, protect from moisture and direct light.
What does Nintedanib Esylate interact with?
Nintedanib Zentiva can interact with other medicines, affecting its plasma levels or increasing adverse event risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): increase bleeding risk. - P‑gp inhibitors (e.g., verapamil): can elevate drug concentrations.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly increase exposure. - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Antacids containing aluminum or magnesium: may affect absorption if taken simultaneously. - NSAIDs: concurrent use may enhance gastrointestinal bleeding risk.



