Europe — EMA
Nintedanib
GNH USA supplies Nintedanib (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung
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What is Nintedanib?
Nintedanib, the active ingredient in Nintedanib, 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 non‑small cell lung cancer in appropriate patients.
GNH USA supplies Nintedanib 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.
Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and delay 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, from mild to serious.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: sensation of unease and 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 possible liver injury. - Bleeding events: includes gastrointestinal or pulmonary hemorrhage. - Cardiovascular events: such as myocardial infarction or stroke. - Severe infections: opportunistic or bacterial infections. - Gastrointestinal perforation: rare but potentially life‑threatening.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess patient‑specific risk factors and monitor for adverse events.
Monitor liver function: perform baseline and periodic liver enzyme tests. Assess bleeding risk: evaluate concomitant anticoagulant use and history of hemorrhage. Evaluate cardiovascular status: watch for signs of ischemic events. Avoid use in pregnancy: teratogenic potential is unknown; contraindicated. Adjust for hepatic impairment: dose may need modification in moderate to severe liver disease. Store at room temperature: keep in the original container, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase nintedanib exposure. - Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk. - P‑glycoprotein inhibitors (e.g., verapamil): can raise plasma concentrations.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise levels. - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - NSAIDs or antiplatelet agents: monitor for additive bleeding. - St. John’s wort: potential reduction in drug exposure. - Proton pump inhibitors: may affect absorption, observe clinical response.



