Drug Interactions between Ofev and pirfenidone

Consumer information for this interaction is not currently available.

MONITOR: Coadministration of nintedanib with pirfenidone does not appear to affect the pharmacokinetics of either medication but may result in additive adverse reactions due to the similarity in their safety profiles. In a dedicated pharmacokinetic study conducted in patients with idiopathic pulmonary fibrosis, pirfenidone given at 801 mg three times a day to steady state did not significantly affect the pharmacokinetics of a single 150 mg dose of nintedanib (n=20). Likewise, coadministration of nintedanib 150 mg twice daily with pirfenidone 801 mg three times a day for at least 7 days had no significant impact on steady state pirfenidone exposures compared to pirfenidone administered alone (n=17). In an exploratory randomized trial comparing nintedanib 150 mg twice daily with add-on pirfenidone titrated to 801 mg three times a day (n=53) against nintedanib 150 mg twice daily alone (n=52) for 12 weeks, similar nintedanib trough plasma concentrations were observed for both treatment arms. However, gastrointestinal events were increased in the nintedanib plus pirfenidone group relative to the nintedanib only group (70% vs. 53%). The most frequent adverse events were diarrhea (38% vs. 31%), nausea (42% vs. 12%), vomiting (28% vs. 12%), and abdominal pain (including upper abdominal pain, abdominal discomfort, and abdominal pain; 28% vs. 14%). In addition, more subjects in the nintedanib plus pirfenidone group relative to the nintedanib only group reported AST or ALT elevations greater than or equal to 3 times the upper limit of normal (6% vs. 0%).

MANAGEMENT: The benefit-to-risk balance of concomitant treatment of nintedanib with pirfenidone has not been established. Based on available pharmacokinetic data, no dosage adjustment is necessary for either medication. However, closer monitoring may be required for increased adverse effects.