Europe — EMA
Nintedanib Accord
GNH USA supplies Nintedanib Accord (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and non‑small cell lung cancer.
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib Accord, is a tyrosine kinase inhibitor presented as a tablet for oral use. It treats idiopathic pulmonary fibrosis and certain non‑small cell lung cancers in adult patients.
GNH USA supplies Nintedanib Accord 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 the following conditions:
Idiopathic pulmonary fibrosis: slows the decline in lung function and reduces disease progression. Non‑small cell lung cancer: used in combination regimens to inhibit tumor growth and angiogenesis. Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delay worsening of fibrosis.
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 loose stools, often mild to moderate. - Nausea: sensation of unease or urge to vomit. - Vomiting: expulsion of stomach contents. - Abdominal pain: discomfort in the stomach area. - Decreased appetite: reduced desire to eat. - Weight loss: unintended reduction in body weight.
Serious or Rare Side Effects: - Elevated liver enzymes: indicates potential liver injury. - Bleeding events: includes gastrointestinal or other hemorrhage. - Cardiovascular events: such as hypertension or arterial thromboembolism. - Severe infections: opportunistic or serious bacterial infections. - Gastrointestinal perforation: rare but life‑threatening. - Severe skin reactions: including Stevens‑Johnson syndrome.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor for adverse events.
Monitor liver function: perform baseline and periodic hepatic enzyme tests. Assess cardiovascular risk: evaluate blood pressure and history of thrombotic disease. Evaluate bleeding risk: review concomitant anticoagulant or antiplatelet use. Use caution in gastrointestinal disorders: patients with ulcer disease may have higher perforation risk. Store below 25°C: keep in the original pack, protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes, requiring attention to avoid reduced efficacy or increased toxicity.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may raise nintedanib exposure. - Anticoagulants (e.g., warfarin): increase bleeding risk. - Antiplatelet agents (e.g., clopidogrel): may potentiate hemorrhagic events.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower drug levels. - Diuretics (e.g., furosemide): can enhance renal excretion and affect fluid balance. - Statins (e.g., simvastatin): may increase risk of liver enzyme elevation.



