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Stability of XARELTO Oral Suspension – Shipping Temperature Data

Last Updated: 12/09/2024

SUMMARY

  • XARELTO oral suspension may be shipped from the manufacturer in a cooler with gel packs to maintain shipping temperature requirements.
    • Once received, XARELTO tablets, granules and reconstituted suspension should be stored at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Do not freeze the granules or reconstituted suspension.1
  • Janssen cannot recommend any practices, procedures, or storage conditions that deviate from the product labeling and are not approved by regulatory authorities.

SHIPPING TEMPERATURE DATA

XARELTO oral suspension has shipping temperature ranges noted in Table: Shipping Temperature Ranges that are more exhaustive than that of the storage requirements listed in the prescribing information and as noted in Table: Storage Temperature Ranges.  

  • Janssen may use qualified passive shipping solutions (e.g. coolers) to ensure that the product maintains the appropriate shipping temperature range during shipping to customers. These coolers have components (e.g. gel packs) that may be cold. This is expected as some of the gel packs are required to be cold to ensure that the appropriate shipping temperature ranges are maintained.
  • If the temperature is taken upon arrival, the temperature may be outside of the storage specific requirements listed in the prescribing information; however, the product is fit for use as long as the temperature upon arrival is within the shipping temperature ranges.

Table: Shipping Temperature Ranges2-4
Product Name & Strength
Shipping Temperature Ranges
XARELTO for Oral Suspension2-4
2°C to 30°C (36.5° to 86°F)

Table: Storage Temperature Ranges1
Product Name & Strength
Storage Temperature Ranges
XARELTO for Oral Suspension1
20° to 25°C (68° to 77°F)
excursions permitted between 15° to 30°C (59° to 86°F)

xarelto Shipping box EXAMPLE ILLUSTRATION

 

References

1 XARELTO (rivaroxaban) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf
2 Data on File. BAY 59-7939 granules 2% for oral application 200 - Temperature-Time-Limits for Evaluation of Temperature Excursions - T.35.80 02. TV-TEC-145770. 2023.  
3 Data on File. Proven Temperature Ranges for JSC Drug Products. TV-TEC-102593. 2023.  
4 Data on File. JNJ-39039039-AAA (BAY 59-7939 Rivaroxaban) Granules 2% for Oral Suspension. TV-TEC-142542. 2023.