Europe — EMA
Nintedanib Aurobindo
GNH USA supplies Nintedanib Aurobindo (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 Aurobindo, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for certain fibrotic lung disorders and selected cancers, acting to limit abnormal cell growth and tissue scarring.\n\nGNH India supplies Nintedanib Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nintedanib is used to treat diseases driven by abnormal fibroblast activity and tumor angiogenesis.\n\nIdiopathic pulmonary fibrosis: slows decline in lung function and reduces disease progression.\nSystemic sclerosis‑associated interstitial lung disease: improves lung capacity and delays worsening.\nNon‑small cell lung cancer: used in combination therapy to inhibit tumor growth and angiogenesis.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions, from mild to severe.\n\nCommon Side Effects:\n- Diarrhea: frequent loose stools, often manageable with diet and hydration.\n- Nausea: feeling of sickness, may improve with food.\n- Vomiting: occasional expulsion of stomach contents.\n- Abdominal pain: discomfort or cramps in the stomach area.\n- Elevated liver enzymes: increased ALT/AST detected in blood tests.\n- Decreased appetite: reduced desire to eat.\n\nSerious or Rare Side Effects:\n- Hepatotoxicity: signs of liver injury such as jaundice or dark urine.\n- Severe bleeding: unexpected bruising or hemorrhage, especially with anticoagulants.\n- Cardiovascular events: hypertension or arterial thrombotic events.\n- Interstitial lung disease exacerbation: worsening respiratory symptoms.\n- Allergic reactions: rash, itching, or swelling of the face and throat.
What precautions apply to Nintedanib?
Patients should be monitored for specific safety concerns before and during therapy.\n\nLiver function monitoring: obtain baseline and periodic ALT/AST tests.\nBleeding risk assessment: evaluate concomitant anticoagulant or antiplatelet use.\nCardiovascular evaluation: monitor blood pressure and signs of arterial events.\nPregnancy and lactation: avoid use as safety has not been established.\nDrug interactions: review all concomitant medications for potential CYP3A4 interactions.\nStore at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib can interact with several drug classes, requiring careful management.\n\nMajor Interactions (Avoid):\n- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.\n- Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.\n- Antiplatelet agents (e.g., aspirin, clopidogrel): additive hemorrhagic potential.\n\nModerate Interactions (Monitor Closely):\n- Moderate CYP3A4 inhibitors (e.g., fluconazole): may modestly raise plasma levels.\n- CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.\n- P‑glycoprotein substrates (e.g., digoxin): possible altered absorption.



