Europe — EMA
Nintedanib Sandoz
GNH USA supplies Nintedanib Sandoz (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated ILD
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Sandoz, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is used to treat idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and certain types of non‑small cell lung cancer.
GNH USA supplies Nintedanib Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncogenic pathways. It is indicated for: - Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delays worsening. - Non‑small cell lung cancer: used in combination therapy to inhibit tumor growth.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions. Patients should be informed of the most frequently observed events and the rarer but serious possibilities.
Common Side Effects: - Nausea: mild to moderate upset stomach. - Diarrhoea: frequent loose stools. - Decreased appetite: reduced desire to eat. - Abdominal pain: discomfort in the stomach area.
Serious or Rare Side Effects: - Severe liver injury: elevated liver enzymes or hepatitis. - Major bleeding: gastrointestinal or intracranial hemorrhage. - Cardiovascular events: myocardial infarction or stroke. - Gastrointestinal perforation: rare but life‑threatening. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should consider several safety measures. - Monitor liver function: obtain baseline tests and repeat periodically. - Assess cardiovascular risk: review history of ischemic heart disease or stroke. - Avoid in severe hepatic impairment: contraindicated when liver function is markedly compromised. - Use caution with gastrointestinal disorders: patients with ulcers or inflammatory bowel disease may experience worsening symptoms. - Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin): heightened risk of bleeding. - P‑glycoprotein inhibitors (e.g., itraconazole): raise plasma concentrations.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin): may reduce therapeutic effect. - Antiplatelet agents (e.g., aspirin): monitor for additive bleeding risk. - Diuretics: potential for dehydration and renal impairment.



