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 was conducted to evaluate the stability of REMICADE following reconstitution and further dilution with 0.9% Sodium Chloride (NS) to a final concentration of 0.4 mg/mL and 4 mg/mL, and storage at room temperature for 24 hours in polyethylene and ethyl vinyl acetate infusion bags, and glass infusion bottles. The findings of this study suggest that REMICADE, over the dilution range from 0.4 mg/mL to 4.0 mg/mL in NS, is physically and biochemically stable for 24 hours at room temperature.²
• Because REMICADE contains no preservative, infusions of REMICADE should be prepared under aseptic conditions and should begin within 3 hours of preparation to ensure against microbiological contamination.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 situation outside of recommended storage requirements. This information is in response to your unsolicited request.

PRODUCT LABELING

Please refer to the following sections of the full Prescribing Information that are 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 following reconstitution and further dilution with NS to a final concentration of 0.4 mg/mL and 4 mg/mL, and storage at room temperature for 24 hours in polyethylene and ethyl vinyl acetate infusion bags, and glass infusion bottles.²

• Visible particles, sub-visible particles, turbidity, and soluble aggregates in infusion bags of REMICADE at both concentrations were unchanged over 24 hours. No loss of REMICADE through absorption to the polyethylene or ethyl vinyl acetate bags was observed.
• Similarly, results for REMICADE stored in glass bottles for 24 hours at room temperature indicated that there was no change in visible particles, sub-visible particles, turbidity, or soluble aggregates at both concentrations.
• The findings of this study suggest that REMICADE, over the dilution range from 0.4 mg/mL to 4.0 mg/mL in NS, is physically and biochemically stable for 24 hours at room temperature in polyethylene and ethyl vinyl acetate infusion bags and glass infusion bottles.
• However, because REMICADE contains no preservative, infusions of REMICADE should be prepared under aseptic conditions and should begin within 3 hours of preparation to ensure against microbiological contamination.

Utilization of any parenteral solution should follow proper aseptic technique and local institutional policies or utilization of guidelines for compounding sterile preparations as provided by the American Society of Health-System Pharmacists (ASHP) to prevent the growth of a pathological bioburden of microorganisms and limit the risk of morbidity and mortality.³

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 01 June 2023.