RT Journal Article
SR Electronic
T1 No relevant pharmacokinetic drug–drug interaction between nintedanib and pirfenidone
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1801060
DO 10.1183/13993003.01060-2018
VO 53
IS 1
A1 Luca Richeldi
A1 Sophie Fletcher
A1 Huzaifa Adamali
A1 Nazia Chaudhuri
A1 Sabrina Wiebe
A1 Sven Wind
A1 Kathrin Hohl
A1 Andrew Baker
A1 Rozsa Schlenker-Herceg
A1 Susanne Stowasser
A1 Toby M. Maher
YR 2019
UL http://erj.ersjournals.com/content/53/1/1801060.abstract
AB Nintedanib and pirfenidone are approved treatments for idiopathic pulmonary fibrosis (IPF). This open-label, two-group trial investigated the pharmacokinetic drug–drug interaction between these two drugs in patients with IPF.Subjects not treated with antifibrotics at screening (group 1, n=20) received a single nintedanib dose (150 mg) followed by pirfenidone (titrated to 801 mg thrice daily) for 3 weeks, with a further single nintedanib dose (150 mg) on the last day (day 23). Subjects treated with pirfenidone at screening (group 2, n=17) continued to receive pirfenidone alone (801 mg thrice daily) for 7 days, then co-administered with nintedanib (150 mg twice daily) for a further 7 days, before single doses of both treatments on day 16.In group 1, adjusted geometric mean (gMean) ratios (with/without pirfenidone) were 88.6% and 80.6% for nintedanib area under the plasma concentration–time curve (AUC) and maximum plasma concentration (Cmax), respectively. In group 2, gMean ratios (with/without nintedanib) were 97.2% and 99.5% for pirfenidone AUC and Cmax, respectively. For all parameters, the 90% confidence intervals included 100%, suggesting similar exposure for administration alone and when co-administered. Both treatments were well tolerated.These data indicate there is no relevant pharmacokinetic drug–drug interaction between nintedanib and pirfenidone when co-administered in IPF patients.There is no pharmacokinetic interaction between nintedanib and pirfenidone in patients with IPF http://ow.ly/utJD30msHeU