Approved Drugs > Methotrexate Safety information

Changes to Package inserts for Methotrexa​te Products for Intravenou​s Administra​tion

This is to inform you of changes that have been made to the package inserts for methotrexate products for intravenous administration. The following has been added to the WARNINGS section of the label:
WARNINGS
Use caution when administering high-dose methotrexate to patients receiving proton pump inhibitor (PPI) therapy. 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. In two of these cases, delayed methotrexate elimination was observed when high-dose methotrexate was co-administered with PPIs, but was not observed when methotrexate was co-administered with ranitidine. However, no formal drug interaction studies of methotrexate with ranitidine have been conducted.

Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf¹

Approved Drugs > Methotrexate Safety information