Europe — EMA
Nipfilan (Nintedanib)
GNH USA supplies Nipfilan (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 Nipfilan, is a tyrosine kinase inhibitor presented as an oral formulation for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis and certain forms of lung cancer, acting to slow disease progression and inhibit tumor‑related pathways.
GNH USA supplies Nipfilan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Nintedanib used for?
Nintedanib is employed in fibrotic lung disease and oncologic indications where inhibition of multiple growth factor receptors is required.
Idiopathic pulmonary fibrosis: reduces the rate of decline in lung function and delays disease progression. Non‑small cell lung cancer: used in combination regimens to impede tumor growth and angiogenesis. Systemic sclerosis‑associated interstitial lung disease: helps preserve lung capacity and slows fibrotic change.
What are the side effects of Nintedanib?
Adverse reactions vary in frequency and severity.
Common Side Effects: - Diarrhea: frequent, watery stools. - Nausea: mild to moderate upset stomach. - Vomiting: occasional episodes. - Abdominal pain: cramping or discomfort. - Decreased appetite: reduced food intake. - Elevated liver enzymes: increased ALT/AST.
Serious or Rare Side Effects: - Severe liver injury: jaundice, hepatitis. - Major bleeding: gastrointestinal or intracranial hemorrhage. - Cardiovascular events: myocardial infarction, stroke. - Gastrointestinal perforation: severe abdominal pain. - Severe infections: opportunistic bacterial or fungal infections. - Skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess baseline organ function and risk factors. - Liver monitoring: perform baseline and periodic liver function tests. - Cardiovascular assessment: evaluate history of ischemic heart disease. - Bleeding risk: review concomitant anticoagulant or antiplatelet use. - Pregnancy and lactation: avoid use unless benefits outweigh potential risks. - Hepatic impairment: consider dose adjustment or heightened monitoring. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Nintedanib interact with?
Nintedanib may interact with drugs that affect its metabolism or increase bleeding risk.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma levels. - Potent P‑glycoprotein inhibitors (e.g., verapamil): increase exposure. - Anticoagulants (warfarin, direct oral anticoagulants): heightened bleeding tendency.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy. - Antacids containing aluminum or magnesium: could affect absorption. - Non‑steroidal anti‑inflammatory drugs (NSAIDs): monitor for additive bleeding risk. - Herbal supplements (St. John’s wort): may lower drug concentrations.



