Medication Monitor

Generic Name (Trade Name—Company)
September 20, 2019


(Ofev—Boehringer Ingelheim)
FDA approves first treatment for patients with rare lung disease

FDA approved nintedanib, a kinase inhibitor, to slow the rate of decline in pulmonary function in adults with interstitial lung disease (ILD) associated with systemic sclerosis or scleroderma (SSc-ILD). It is the first FDA-approved treatment for this rare lung condition.

Scleroderma causes tissue throughout the body, including the lungs and other organs, to thicken and scar. ILD affects the interstitium and is one of the most common disease manifestations of sclerderma. SSc-ILD is a progressive lung disease in which lung function declines over time, and it can be debilitating and life-threatening. ILD is the leading cause of death among people with scleroderma, typically resulting from a loss of pulmonary function that occurs when the lungs cannot supply enough oxygen to the heart. 

The prescribing information includes warnings for patients with moderate or severe liver impairment, those with elevated liver enzymes and drug-induced liver injury, and those with GI disorders. The drug may also cause embryo-fetal toxicity that can result in fetal harm, arterial thromboembolic events, bleeding, and GI perforation. P-gp and CYP3A4 inhibitors may increase nintedanib exposure, and patients taking these inhibitors should be closely monitored for tolerability.

The recommended dosage is 150 mg twice daily approximately 12 hours apart, taken with food.

Common adverse effects include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight loss, and hypertension.

The agent was originally approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung condition.