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XARELTO®

(rivaroxaban)

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This information is intended for US healthcare professionals to access current scientific information about Janssen products. It is prepared by Janssen Medical Information and is not intended for promotional purposes, nor to provide medical advice.

XARELTO® (rivaroxaban)

Medical Information

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XARELTO - Gluten Content

Last Updated: 06/06/2024

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®, and DERWENT® (and/or other resources, including internal/external databases) conducted on 27 May 2024 did not identify any relevant citations pertaining to this topic.

 

References

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1 Data on File. Patient Safety and Compliance Information (EXC and IMC)-Xarelto 10 mg. Janssen Scientific Affairs, LLC.; 2022.  
2 Data on File. Patient Safety and Compliance Information (EXC and IMC)-Xarelto. 2.5 mg. Janssen Scientific Affairs, LLC.; 2022.  
3 Data on File. Patient safety and compliance information (EXC and IMC)-Xarelto granules for oral suspension 1 mg/mL. Janssen Scientific Affairs, LLC.; 2021.  
4 Data on File. Patient Safety and Compliance Information (EXC and IMC)-Xarelto 15 mg and 20 mg. Janssen Scientific Affairs, LLC.; 2022.