Nintedanib (Generic) (Nintedanib CAPSULE) 100 mg/1

Nintedanib is an oral tyrosine kinase inhibitor approved by the FDA for treating idiopathic pulmonary fibrosis (IPF) and chronic fibrosing interstitial lung diseases (ILDs). It represents a significant therapeutic advance in pulmonology by slowing disease progression in patients with progressive fibrosing lung conditions. This orphan drug designation reflects its role in treating rare, life-threatening respiratory disorders.

Strength

100 mg/1

Pack Size

60 CAPSULE in 1 BOTTLE (51407-984-60)

Manufacturer / TM Owner

Generic

Select Quantity

Pack/s

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Indications & Clinical Uses

Nintedanib is indicated for patients with idiopathic pulmonary fibrosis (IPF) and other chronic fibrosing interstitial lung diseases (ILDs) to slow disease progression. The drug targets multiple pathways involved in pulmonary fibrosis by inhibiting tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors, fibroblast growth factor (FGF) receptors, and platelet-derived growth factor (PDGF) receptors. This mechanism helps reduce fibroblast proliferation and activation, key drivers of lung scarring. Nintedanib is prescribed to adult patients with progressive fibrosing ILDs, including IPF, nonspecific interstitial pneumonia (NSIP), and other related conditions. The drug is typically used as monotherapy or in combination with other antifibrotic agents, helping to preserve lung function and improve quality of life in this patient population with limited treatment options.

Side Effects

Common side effects of nintedanib include gastrointestinal disturbances such as diarrhea, nausea, vomiting, and abdominal pain, which occur in a significant proportion of patients. Hepatotoxicity and elevated liver enzymes are notable adverse events requiring monitoring. Serious adverse events include bleeding, thromboembolic events, and gastrointestinal perforation. Patients require regular monitoring of liver function tests (LFTs), complete blood counts (CBC), and renal function. Dose adjustments or discontinuation may be necessary if severe hepatotoxicity develops. Gastrointestinal side effects often improve with dose reduction or management strategies, and most patients tolerate the medication with appropriate monitoring and supportive care.

Precautions & Warnings

Nintedanib is contraindicated in patients with severe hepatic impairment and requires dose adjustment in moderate hepatic or renal impairment. It is not recommended during pregnancy due to potential teratogenic effects and is contraindicated in nursing mothers. Pediatric use has not been established. Caution is advised in patients with bleeding disorders, recent surgery, or concurrent anticoagulant therapy. Patients with active infections or compromised immune function require careful evaluation. Regular monitoring of liver and renal function is essential. The drug should be used cautiously in elderly patients and those with cardiovascular disease. Baseline and periodic assessment of pulmonary function and clinical status is recommended to evaluate therapeutic response and tolerability.

Avoid Interactions

Nintedanib is a substrate of CYP3A4 and P-glycoprotein; concurrent use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase nintedanib concentrations and require dose adjustment. Strong CYP3A4 inducers (e.g., rifampicin, phenytoin) may decrease nintedanib efficacy. Concurrent anticoagulants or antiplatelet agents increase bleeding risk. NSAIDs should be used cautiously due to gastrointestinal and renal effects. No significant food interactions have been identified, though consistent administration timing is recommended for optimal absorption and tolerability.

Frequently Asked Questions

Nintedanib is used to treat idiopathic pulmonary fibrosis (IPF) and other chronic fibrosing interstitial lung diseases (ILDs) in adults. It works by inhibiting tyrosine kinases involved in fibroblast proliferation and lung scarring, helping to slow disease progression and preserve lung function in patients with progressive fibrosing lung conditions.

Nintedanib is administered orally as a capsule, typically at a dose of 150 mg twice daily with food. The medication should be taken consistently at the same times each day. Dose adjustments may be necessary based on tolerability, liver function, or renal impairment.

The most common side effects include diarrhea, nausea, vomiting, and abdominal pain. Elevated liver enzymes and hepatotoxicity can occur and require monitoring. Most gastrointestinal side effects are manageable with dose adjustment or supportive care and tend to improve over time.

Nintedanib is available as a generic medication from multiple manufacturers. Originally developed and marketed by Boehringer Ingelheim under the brand name Ofev, generic versions are now produced by various pharmaceutical companies.

Yes, nintedanib received orphan drug designation from the FDA for the treatment of idiopathic pulmonary fibrosis and other fibrosing interstitial lung diseases. This designation recognizes its role in treating rare, serious conditions with limited treatment options and provides regulatory incentives for development and approval.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 17 Jun 2026

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