Label Changes for:
Dexilant (dexlansoprazole) delayed-release capsules
Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- … Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole
WARNINGS AND PRECAUTIONS
Acute Interstitial Nephritis
Cyanocobalamin (vitamin B12) Deficiency
*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil
5 WARNINGS AND PRECAUTIONS
5.4 Concomitant Use of DEXILANT with Methotrexate
- Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7.5)].
7 DRUG INTERACTIONS
- Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate .....
- section added....