Package Inserts Revised for IV Methotrexate Products

The FDA has approved changes to the package inserts for methotrexate products for intravenous administration. Additional information regarding concomitant proton pump inhibitor (PPI) therapy has been added to the Warning section of the label. Specifically, the new text includes the following statement: “Case reports and published population pharmacokinetic studies suggest that concomitant use of some PPIs, such as omeprazole, esomeprazole, and pantoprazole, with methotrexate (primarily at high dose), may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.” ■