Europe — EMA
Nifiden Adalvo (Nintedanib)
GNH USA supplies Nifiden Adalvo (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 Nifiden Adalvo, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and as part of combination therapy for non‑small cell lung cancer.
GNH USA supplies Nifiden Adalvo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib acts on multiple receptor tyrosine kinases involved in fibrotic and oncologic 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 that vary in frequency and severity.
Common Side Effects: - Diarrhoea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may be transient. - Elevated liver enzymes: increased ALT/AST levels. - Decreased appetite: reduced desire to eat.
Serious or Rare Side Effects: - Hepatotoxicity: significant liver injury requiring monitoring. - Bleeding events: increased risk of gastrointestinal or other bleeding. - Cardiovascular events: rare cases of myocardial infarction or stroke.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline organ function and comorbidities. - Liver function monitoring: check ALT/AST before and during treatment. - Gastrointestinal health: evaluate for pre‑existing diarrhoea or ulcer disease. - Bleeding risk: avoid concurrent anticoagulants unless necessary. - Pregnancy and lactation: avoid use due to unknown safety profile. - Store at ambient temperature: keep below 25 °C, retain original packaging and protect from moisture.
What does Nintedanib interact with?
Nintedanib can interact with drugs that affect its metabolism or increase bleeding risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise nintedanib exposure. - Anticoagulants (e.g., warfarin): heightened bleeding potential.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly increase levels. - P‑gp inhibitors (e.g., verapamil): could affect absorption. - CYP3A4 inducers (e.g., rifampicin): may reduce efficacy. - Antiplatelet agents (e.g., aspirin): monitor for signs of bleeding.



