NINTIB contains nintedanib, a small-molecule tyrosine kinase inhibitor with antifibrotic activity. In fibrosing lung diseases, its primary therapeutic role is to slow the decline of lung function, rather than reverse established scar tissue.
How it works:
Patients who may be prescribed nintedanib include:
INPULSIS-1 and INPULSIS-2. These two randomized Phase 3 trials included 1,066 patients with idiopathic pulmonary fibrosis. Nintedanib significantly reduced the annual rate of decline in forced vital capacity compared with placebo. The between-group difference was 125.3 mL per year in INPULSIS-1 and 93.7 mL per year in INPULSIS-2. Diarrhea was the most frequently reported adverse event.
INBUILD. This Phase 3 trial evaluated nintedanib in progressive fibrosing interstitial lung diseases. Over 52 weeks, the adjusted annual decline in FVC was −80.8 mL with nintedanib compared with −187.8 mL with placebo.
In the full-trial analysis, disease progression or death occurred in 40.4% of patients receiving nintedanib versus 54.7% receiving placebo, with a hazard ratio of 0.66.
SENSCIS. This Phase 3 trial included 576 patients with systemic sclerosis-associated interstitial lung disease. The annual decline in FVC was −52.4 mL with nintedanib compared with −93.3 mL with placebo.
LUME-Lung 1. This Phase 3 oncology trial evaluated nintedanib plus docetaxel in previously treated non-small-cell lung cancer. In the overall population, median progression-free survival was 3.4 months with nintedanib plus docetaxel versus 2.7 months with docetaxel plus placebo.
These studies provide a substantial clinical evidence base for nintedanib in progressive fibrosing lung diseases and selected oncology settings.
NINTIB is used in adults for:
Nintedanib does not reverse established pulmonary fibrosis but may slow further loss of lung function.
For idiopathic pulmonary fibrosis, progressive fibrosing interstitial lung diseases, and systemic sclerosis-associated interstitial lung disease, the recommended adult dose is 150 mg twice daily approximately 12 hours apart. Capsules should be taken with food and swallowed whole with liquid. They should not be chewed, opened, or crushed. If a dose is missed, the next dose should be taken at the scheduled time without doubling the dose. Dose adjustments, temporary treatment interruption, or discontinuation should be determined by the treating physician according to tolerability and clinical status.
Patients should seek medical attention for persistent or severe diarrhea, dehydration, yellowing of the skin or eyes, dark urine, unusual bleeding, or other serious symptoms.
