From the Guidelines
Ofev (nintedanib) is a prescription medication primarily used to treat certain types of interstitial lung diseases, including idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype, and interstitial lung disease associated with systemic sclerosis. It works by blocking multiple tyrosine kinases and growth factor receptors involved in fibrosis (scarring) and inflammation in the lungs. Ofev is typically taken as a 150 mg capsule twice daily with food, though some patients may require a reduced dose of 100 mg twice daily if they experience side effects. Common side effects include:
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Liver enzyme elevation
- Decreased appetite
- Weight loss Patients taking Ofev should have regular liver function tests and should inform their healthcare provider about all other medications they're taking, as drug interactions can occur. While Ofev cannot reverse existing lung damage, it can slow disease progression by reducing the rate of decline in lung function, potentially extending patients' quality of life and survival time, as shown in studies such as INPULSIS-1 and INPULSIS-2 1. The 2023 American College of Rheumatology (ACR)/American College of Chest Physicians (CHEST) guideline for the treatment of interstitial lung disease in people with systemic autoimmune rheumatic diseases conditionally recommends nintedanib as a first-line ILD treatment option for people with SSc-ILD 1. However, for people with SjD-ILD, IIM-ILD, and MCTD-ILD, the guideline conditionally recommends against nintedanib as a first-line ILD treatment option 1. Nintedanib has been shown to increase gastrointestinal adverse effects, including abdominal pain, nausea, vomiting, diarrhea, anorexia, weight loss, elevated aspartate aminotransferase, and elevated alanine aminotransferase 1. Overall, the use of Ofev should be individualized and based on the specific type of interstitial lung disease, disease severity, and patient factors, with consideration of the potential benefits and risks, as recommended in the most recent guidelines 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Definition and Mechanism of Ofev
- Ofev, also known as nintedanib, is an oral triple kinase inhibitor that targets pro-fibrotic pathways 2.
- It inhibits receptor tyrosine kinases implicated in the pathogenesis of idiopathic pulmonary fibrosis (IPF) 3.
- Nintedanib is an intracellular tyrosine kinase inhibitor with antifibrotic properties, targeting platelet-derived growth factor receptor, fibroblast growth factor receptor, and vascular endothelial growth factor receptor 4.
Uses of Ofev
- Ofev is used for the treatment of idiopathic pulmonary fibrosis (IPF) 3, 4.
- It has also been approved for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) 2, 5.
- Nintedanib has been shown to slow disease progression in patients with IPF and other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype 5.
Efficacy and Safety
- Nintedanib has been shown to significantly reduce the annual rate of decline in forced vital capacity (FVC) in patients with IPF and SSc-ILD 2, 5.
- The most common adverse events associated with nintedanib are gastrointestinal disorders, including diarrhea, nausea, and vomiting 2, 3.
- Nintedanib has a manageable tolerability profile in patients with fibrotic ILDs, with no new safety signals emerging from global pharmacovigilance data 5.