From the Guidelines
Nintedanib is recommended to be prescribed at a dose of 150 mg taken twice daily, approximately 12 hours apart with food, with a possible reduction to 100 mg twice daily if not tolerated 1. The medication comes in capsule form and should be swallowed whole with water. Dose adjustments are necessary for patients with liver impairment or those experiencing significant adverse effects. Common side effects include:
- Diarrhea
- Nausea
- Abdominal pain
- Elevated liver enzymes Diarrhea, the most common side effect, can be managed with antidiarrheal medications like loperamide. Regular liver function monitoring is essential during treatment, with LFTs every month for 3 months, then every 3 months 1. Nintedanib works by inhibiting multiple tyrosine kinases and growth factor receptors involved in angiogenesis and fibrosis, making it effective for conditions like idiopathic pulmonary fibrosis and certain non-small cell lung cancers. The medication should be taken consistently at the same times each day to maintain steady blood levels for optimal therapeutic effect. It is worth noting that the most recent and highest quality study, published in 2023 in Nature Reviews Rheumatology, supports the use of nintedanib at this dosage for the treatment of systemic sclerosis 1. In contrast, other studies, such as the 2024 guideline for the treatment of interstitial lung disease, also recommend similar dosing and monitoring for nintedanib 1. However, older studies, such as the 2012 study on chronic myelogenous leukemia, are not directly relevant to the current recommendation for nintedanib dosage 1.
From the Research
Recommended Dosage of Nintedanib
- The recommended dosage of Nintedanib is 150 mg twice daily 2, 3, 4
- This dosage has been shown to slow disease progression in patients with idiopathic pulmonary fibrosis (IPF) 2, 3, 4
- In some cases, a dosage of 100 mg twice daily may be used 4
Safety and Tolerability
- The safety and tolerability profile of Nintedanib is manageable for most patients 2, 4
- Common adverse events include diarrhea and nausea 2, 4
- The long-term safety and tolerability of Nintedanib has been evaluated in the INPULSIS-ON study, which showed no new safety signals 4
Clinical Trials and Studies
- Clinical trials have demonstrated the efficacy and safety of Nintedanib in patients with IPF 2, 3, 4
- The INPULSIS trials showed a significant decrease in the annual rate of decline in forced vital capacity in IPF patients treated with Nintedanib 3, 4
- The INPULSIS-ON study evaluated the long-term safety and tolerability of Nintedanib in patients with IPF 4