Europe — EMA
Nintedanib Newbury
GNH USA supplies Nintedanib Newbury (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and systemic sclerosis‑associated
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Newbury, is a tyrosine kinase inhibitor presented as a tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease in adult patients.
GNH USA supplies Nintedanib Newbury as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib is an antifibrotic agent used in specific interstitial lung disease pathways.
Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function. Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity and improves quality of life.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea: frequent, watery stools often requiring supportive care. - Nausea and vomiting: mild to moderate, may improve with food intake. - Abdominal pain: crampy discomfort in the upper abdomen. - Decreased appetite: reduced desire to eat, potentially leading to weight loss.
Serious or Rare Side Effects: - Elevated liver enzymes: may indicate hepatic injury; monitor transaminases. - Severe bleeding: gastrointestinal or other hemorrhagic events. - Arterial thromboembolism: rare clot formation in arteries, requiring urgent evaluation.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline organ function and risk factors. - Liver function monitoring: obtain baseline and periodic ALT/AST levels. - Cardiovascular assessment: evaluate for history of ischemic heart disease or uncontrolled hypertension. - Bleeding risk: avoid concomitant use with strong anticoagulants unless medically necessary. - Pregnancy and lactation: use is not recommended; benefits must outweigh potential risks. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib interacts with several drug classes that can alter its exposure or safety profile.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase plasma concentrations. - Potent P‑gp inhibitors (e.g., clarithromycin): can raise exposure levels. - Anticoagulants (e.g., warfarin) combined with high bleeding risk agents: may potentiate hemorrhage.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce therapeutic effect. - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): require dose adjustment or close monitoring. - Antacids or proton‑pump inhibitors: may affect absorption; separate administration times if needed.



