Europe — EMA
Nipfilan (Nintedanib)
GNH USA supplies Nipfilan (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis and systemic sclerosis‑associated ILD.
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What is Nintedanib?
Nintedanib, the active ingredient in Nipfilan, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for idiopathic pulmonary fibrosis and systemic sclerosis‑associated interstitial lung disease in adult patients.
GNH USA supplies Nipfilan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Nintedanib used for?
Nipfilan belongs to the tyrosine kinase inhibitor class and is used to treat fibrotic lung conditions.
Idiopathic pulmonary fibrosis (IPF): slows disease progression and reduces decline in lung function. Systemic sclerosis‑associated interstitial lung disease (SSc‑ILD): improves lung capacity and delays fibrosis. Progressive fibrosing interstitial lung disease (PF‑ILD): helps preserve lung function across multiple fibrotic subtypes.
What are the side effects of Nintedanib?
Nipfilan may cause a range of adverse reactions.
Common Side Effects: - Nausea: mild to moderate upset stomach. - Diarrhea: frequent loose stools. - Abdominal pain: cramping or discomfort. - Decreased appetite: reduced desire to eat. - Vomiting: occasional expulsion of stomach contents. - Weight loss: unintended loss of body weight.
Serious or Rare Side Effects: - Elevated liver enzymes: potential liver injury. - Bleeding events: increased risk of gastrointestinal or other bleeding. - Cardiovascular events: possible heart failure or ischemic events. - Severe infections: opportunistic or serious bacterial infections. - Gastrointestinal perforation: rare but life‑threatening ulceration. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should evaluate several safety parameters.
Monitor liver function: perform baseline and periodic hepatic enzyme tests. Assess cardiovascular risk: consider history of heart disease before use. Evaluate bleeding risk: avoid in patients with active ulcers or on strong anticoagulants. Counsel on gastrointestinal symptoms: advise patients to report persistent nausea or diarrhea. Avoid in severe hepatic impairment: contraindicated when liver function is markedly compromised. Store at room temperature: keep in the original container, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nipfilan can interact with other medicines, 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‑gp inhibitors (e.g., verapamil): can raise plasma concentrations.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce effectiveness. - NSAIDs (e.g., ibuprofen, naproxen): increase gastrointestinal toxicity. - Statins (e.g., simvastatin, atorvastatin): potential for increased statin levels.



