Summary

• XARELTO tablets and their excipients do not contain gluten as an ingredient.^{1, 2}
• XARELTO granules for oral suspension and their excipients do not contain gluten as an ingredient.³

PRODUCT LABELING

Please refer to the following sections of the enclosed Full Prescribing Information that are relevant to your inquiry: DESCRIPTION.

GLUTEN CONTENT

XARELTO tablets, granules for oral suspension and their excipients do not contain wheat, rye, barley, oats, spelt, or kamut. XARELTO excipients do not contain gluten as an ingredient.^1-4

Mannitol, an inactive ingredient in the granules for oral suspension, can be derived from wheat. Wheat gluten content is < 20 mg/kg.³

Since XARELTO tablets, granules for oral suspension, and their excipients are not tested for gluten, the possibility of cross-contamination with gluten during the manufacturing process of the individual ingredients cannot be eliminated.^{1, 3}

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) conducted on 07 June 2023 did not identify any relevant citations pertaining to this topic.