Europe — EMA
Nifib (Nintedanib Esylate)
GNH USA supplies Nifib (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, non‑small cell lung cancer and systemic
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What is Nintedanib Esylate?
Nintedanib, the active ingredient in Nifib, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is used to treat idiopathic pulmonary fibrosis, non‑small cell lung cancer and systemic sclerosis‑associated interstitial lung disease in adult patients. The drug is marketed in the European Union and follows the regulatory standards for antifibrotic and anti‑angiogenic agents.
GNH USA supplies Nifib as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib Esylate used for?
Nifib is a tyrosine kinase inhibitor that targets pathways involved in fibrosis and tumor angiogenesis.
- Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function. - Non‑small cell lung cancer: inhibits tumor growth when used in combination with chemotherapy. - Systemic sclerosis‑associated interstitial lung disease: reduces fibrotic activity and improves respiratory capacity.
What are the side effects of Nintedanib Esylate?
Adverse reactions may vary in frequency and severity.
Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Diarrhea: frequent loose stools, may require hydration. - Abdominal pain: cramp‑like discomfort. - Decreased appetite: reduced food intake. - Vomiting: occasional episodes. - Weight loss: unintended loss of body mass.
Serious or Rare Side Effects: - Elevated liver enzymes: potential hepatotoxicity requiring monitoring. - Bleeding events: increased risk of gastrointestinal or other hemorrhage. - Cardiovascular events: hypertension or arterial thrombotic episodes. - Severe infections: opportunistic infections in immunocompromised patients. - Gastrointestinal perforation: rare but life‑threatening condition. - Interstitial lung disease exacerbation: worsening of underlying lung pathology.
What precautions apply to Nintedanib Esylate?
Patients should be monitored for safety concerns before and during therapy.
- Liver function monitoring: assess transaminases and bilirubin regularly. - Bleeding risk assessment: evaluate concomitant anticoagulant use and history of hemorrhage. - Cardiovascular evaluation: check blood pressure and cardiac status. - Gastrointestinal caution: avoid in patients with active ulcers or severe GI disorders. - Hepatic impairment: contraindicated in severe liver dysfunction. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Nintedanib Esylate interact with?
Nifib may interact with several drug classes; clinical judgment is required.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk. - P‑glycoprotein inhibitors (e.g., verapamil): can raise plasma levels.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise concentrations. - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Antacids containing aluminum or magnesium: may affect absorption if taken simultaneously.



