Europe — EMA
Nintedanib Newbury
Nintedanib, the active ingredient in Nintedanib Newbury, is a tyrosine kinase inhibitor presented as an oral formulation for oral use.
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Newbury, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and in combination therapy for non‑small cell lung cancer, helping to slow disease progression in these conditions.\n\nGNH India supplies Nintedanib Newbury as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib is used to target fibrotic and oncologic pathways in several serious lung disorders.\n\n- Idiopathic pulmonary fibrosis: slows decline in forced vital capacity, reduces exacerbation rate, and helps preserve quality of life.\n- Systemic sclerosis‑associated interstitial lung disease: helps maintain lung volumes, delays fibrosis progression, and may improve functional outcomes.\n- Non‑small cell lung cancer (in combination therapy): adds anti‑angiogenic activity to chemotherapy, contributing to disease control and potentially extending survival.
What are the side effects of Nintedanib?
Nintedanib may be associated with a range of adverse reactions, which are categorized by frequency and severity.\n\nCommon Side Effects:\n- Diarrhea: frequent loose stools that may be mild, moderate, or occasionally severe and can lead to dehydration.\n- Nausea: a sensation of sickness that may be transient or persist, sometimes accompanied by loss of appetite.\n- Elevated liver enzymes: mild to moderate increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) observed in laboratory tests.\n\nSerious or Rare Side Effects:\n- Hepatotoxicity: clinically significant liver injury that may present with jaundice, elevated bilirubin, or hepatic failure.\n- Bleeding events: gastrointestinal hemorrhage or other serious bleeding that may require medical intervention.\n- Severe infections: opportunistic or serious infections, including pneumonia, that can occur in patients with compromised immunity.
What precautions apply to Nintedanib?
When prescribing Nintedanib, clinicians should consider several precautionary measures to minimize risk and ensure safe use.\n\n- Liver function monitoring: assess baseline ALT/AST and bilirubin,



