Summary

• REMICADE vials do not contain antibacterial preservatives. Therefore, any unused portion of the infusion solution should not be stored for reuse.¹
• A study conducted to evaluate the stability of REMICADE after reconstitution with Sterile Water for Injection (SWFI), 5% Dextrose (D5W), and 0.9% Sodium Chloride (NS) and stored at ambient room temperature suggests that REMICADE reconstituted with SWFI or NS remains stable for 24 hours at room temperature. Reconstitution with D5W is not recommended.²

Janssen Biotech, Inc. cannot recommend any practices, procedures, or storage conditions that deviate from the product labeling and are not approved by the Food and Drug Administration. Data are available for situations outside of recommended storage requirements. This information is in response to your unsolicited request.

PRODUCT LABELING

Please refer to the following section of the full Prescribing Information that is relevant to your inquiry: DOSAGE AND ADMINISTRATION: General Considerations and Instructions for Preparation and Administration.

CLINICAL DATA

A study was conducted to evaluate the stability of REMICADE after reconstitution with SWFI, D5W, and NS.²

• The reconstituted solutions were stored at ambient room temperature.
• The physical characteristics of REMICADE remained unchanged for 24 hours after reconstitution in SWFI, D5W, or NS.
• There was no change in particle formation, soluble aggregates, protein concentration, and immunoreactivity.
• However, 24 hours after reconstitution with D5W, the isoelectric focusing (IEF) banding pattern did not conform to the reference standard and was irreversible.

In summary, the results from this study suggest that REMICADE reconstituted with SWFI or NS remains biochemically and physically stable for 24 hours at room temperature. Reconstitution with D5W is not recommended because of the irreversible reaction of dextrose with REMICADE.²

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 02 June 2023.