Europe — EMA
Nintedanib Stada
GNH USA supplies Nintedanib Stada (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated ILD and NSCLC
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Stada, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It treats idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and is used in combination therapy for non‑small cell lung cancer. GNH USA supplies Nintedanib Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib Stada acts on multiple receptor tyrosine kinases involved in fibrotic and oncogenic pathways. - 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 (in combination therapy): contributes to tumor growth inhibition when used with other anticancer agents.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions.
Common Side Effects: - Nausea: mild to moderate upset stomach. - Diarrhea: frequent loose stools, often manageable with hydration. - Vomiting: occasional episodes, especially early in therapy. - Decreased appetite: reduced desire to eat, may lead to weight loss. - Abdominal pain: cramping or discomfort in the stomach area. - Elevated liver enzymes: laboratory indication of hepatic stress.
Serious or Rare Side Effects: - Hepatic failure: signs include jaundice, dark urine, or severe fatigue. - Severe bleeding: gastrointestinal or intracranial hemorrhage requiring medical attention. - Arterial thromboembolism: sudden chest pain, limb ischemia, or stroke symptoms. - Severe hypertension: markedly high blood pressure needing urgent control. - Gastrointestinal perforation: sudden severe abdominal pain, fever, and peritonitis.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline organ function and comorbidities. - Liver monitoring: perform baseline and periodic liver function tests. - Cardiovascular assessment: evaluate history of hypertension, ischemic disease, or thromboembolic events. - Bleeding risk: review concomitant anticoagulant or antiplatelet use. - Gastrointestinal health: caution in patients with ulcer disease or recent surgery. - Pregnancy and lactation: avoid use unless benefits outweigh potential risks. - Store at below 25°C: keep in the original pack, protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk. - Antiplatelet agents (e.g., clopidogrel, high‑dose aspirin): additive hemorrhagic potential.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Calcium channel blockers (e.g., amlodipine, nifedipine): may increase plasma levels modestly. - Statins metabolised by CYP3A4 (e.g., simvastatin, atorvastatin): monitor for muscle toxicity.



