SUMMARY  

• XARELTO for oral suspension is supplied as white to off-white granules in an amber glass bottle containing 155 mg rivaroxaban packaged with two oral dosing syringes.¹
• As per the XARELTO prescribing information, only use the XARELTO oral dosing syringes provided with the oral suspension package. Johnson and Johnson does not endorse or recommend the use of other commercially available oral dosing syringes.¹
• In a hold time stability study of drug product batches of rivaroxaban 1 mg/mL oral suspension, analysis was performed using the provided oral dosing syringe.²
  • As the hold time stability study was performed using the aforementioned specific syringe, no data is available on other types or brands of oral dosing syringes from this analysis.²
• Studies evaluating user performance supported the use of only the provided specific oral dosing syringe, further described below. For this reason, Johnson and Johnson does not have any data to support the use of alternate oral dosing syringes.³

Additional data

The oral dosing syringe is a 5 mL (non-Luer) plastic syringe that consists of a transparent barrel and purple colored plunger. One side of the syringe label contains 13 color zones along the length of the barrel to indicate the dose. The other side of the label contains 1 mL major graduation lines and markers, 0.5 mL minor graduation lines, and 0.1 mL minor graduations lines. Either side of the syringe label may be used to set the dose. The plastic press in bottle adapter (PIBA) assures a proper connection between the medicine bottle and the syringe.⁴

The syringe barrel is composed of polypropylene and the plunger is low-density polyethylene with a colorant. The PIBA is composed of low-density polyethylene.⁴

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 06 January 2024.