GNH USA

Europe — EMA

Ofev (Nintedanib)

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What is Nintedanib?

Nintedanib, the active ingredient in Ofev, is a tyrosine kinase inhibitor presented as a 150 mg capsule for oral use. It is indicated for the treatment of progressive fibrotic lung diseases, specifically idiopathic pulmonary fibrosis and chronic fibrosing interstitial lung diseases with a progressive phenotype.

GNH USA supplies Ofev as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and specialty pharmacies worldwide.

What is Nintedanib used for?

Ofev is a tyrosine kinase inhibitor that targets pathways involved in fibrotic disease progression. - Idiopathic pulmonary fibrosis (IPF): slows the decline of lung function and reduces disease progression. - Chronic fibrosing interstitial lung disease (CFILD) with a progressive phenotype: helps preserve lung capacity. - Systemic sclerosis‑associated interstitial lung disease (SSc‑ILD): contributes to stabilising lung function. - Progressive pulmonary fibrosis secondary to other connective‑tissue diseases: aids in slowing the rate of functional decline.

What are the side effects of Nintedanib?

Adverse reactions reported with nintedanib vary in frequency and severity.

Common Side Effects: - Diarrhea: frequent, watery stools. - Nausea: mild to moderate upset. - Abdominal pain: cramping or discomfort. - Decreased appetite: reduced food intake. - Elevated liver enzymes (ALT/AST): mild laboratory changes. - Headache: occasional.

Serious or Rare Side Effects: - Severe liver injury (hepatitis or fulminant failure). - Gastrointestinal perforation (e.g., bowel perforation). - Severe bleeding events, including pulmonary hemorrhage. - Cardiovascular events such as myocardial infarction. - Severe hypersensitivity reactions (anaphylaxis, angioedema).

What precautions apply to Nintedanib?

When prescribing Ofev, clinicians should consider several safety aspects. - Liver function monitoring: baseline and periodic laboratory tests are required. - Bleeding risk assessment: evaluate for concomitant anticoagulants or bleeding disorders. - Gastrointestinal health: monitor for signs of perforation or severe diarrhea. - Cardiovascular evaluation: assess history of ischemic heart disease. - Pregnancy and lactation: avoid use unless clearly justified. - Store at ambient temperature: keep in the original packaging, protect from moisture and light.

What does Nintedanib interact with?

Nintedanib may interact with several medicines that affect its absorption or metabolic clearance.

Major Interactions (Avoid): - Strong strong strong strong strong strong strong strong strong strong ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...

Moderate 

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Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Nintedanib
Route
Oral Use
Manufacturer
Boehringer Ingelheim International Gmbh
Origin
EU

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