Europe — EMA
Nintedanib Newbury
GNH USA supplies Nintedanib Newbury (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Newbury, is a tyrosine kinase inhibitor presented as an unknown/unknown for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in adult patients.
GNH USA 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 indicated for several fibrotic and oncologic conditions where inhibition of multiple tyrosine kinases slows disease progression.
- Idiopathic pulmonary fibrosis: reduces decline in lung function and delays overall disease progression. - Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and slows worsening of fibrotic changes. - Non‑small cell lung cancer (in combination therapy): contributes to tumor growth inhibition and improves progression‑free survival.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Diarrhoea: usually mild to moderate and may improve with supportive care. - Nausea: often transient and manageable with anti‑emetics. - Decreased appetite: can lead to weight loss if persistent. - Elevated liver enzymes: requires periodic monitoring.
Serious or Rare Side Effects: - Hepatotoxicity: severe liver injury, indicated by marked transaminase elevation. - Bleeding events: increased risk of gastrointestinal or other bleeding. - Cardiovascular events: rare cases of myocardial infarction or stroke have been reported.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess patient‑specific factors and monitor for potential complications.
- Liver function: evaluate baseline enzymes and repeat monitoring during treatment. - Renal function: assess creatinine clearance, especially in patients with pre‑existing impairment. - Gastrointestinal health: counsel patients on managing diarrhoea and dehydration. - Concomitant anticoagulants: monitor for enhanced bleeding risk. - Pregnancy and lactation: avoid use unless benefits clearly outweigh potential risks. - Store at ambient temperature below 25°C: keep in the original container, protect from moisture and light.
What does Nintedanib interact with?
Nintedanib can interact with other medicines, altering its exposure or increasing toxicity.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nintedanib plasma levels and increase adverse events. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened risk of bleeding.
Moderate Interactions (Monitor Closely): - P‑glycoprotein inhibitors (e.g., verapamil): can modestly increase exposure. - Co‑administration with other anti‑angiogenic agents: additive toxicity may occur. - High‑fat meals: may affect absorption, so advise consistent intake with respect to meals.



