Summary

• REMICADE for injection is supplied as a sterile, preservative-free, white, lyophilized powder for intravenous infusion after reconstitution and dilution.¹
• Store unopened REMICADE vials in a refrigerator at 2°C to 8°C (36°F to 46°F).¹
• If needed, unopened REMICADE vials may be stored at room temperatures up to a maximum of 30ºC (86°F) for a single period of up to 6 months but not exceeding the original expiration date. The new expiration date must be written in the space provided on the carton. Once removed from the refrigerator, REMICADE cannot be returned to the refrigerator.¹
• Please refer to the enclosed full Prescribing Information for further and complete information.

STABILITY DATA

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. Off-label data are available for situations outside of recommended storage requirements. This information is in response to your unsolicited request.

An investigation was conducted to evaluate the stability of unreconstituted, commercial vials of REMICADE exposed to –20°C (-4°F) or 50°C (122°F). Following exposure, the vials were stored within the recommended temperature range of 2°C to 8°C (36°F to 46°F) and stability was monitored for up to 28 months from exposure.²

Exposure to –20°C (-4°F) for 7 Days

Storage of REMICADE for 28 months within the recommended temperature range of 2°C to 8°C (36°F to 46°F) following an exposure to –20°C (-4°F) for 7 days with 3 freeze/thaw cycles demonstrated no adverse effect on the biochemical or physical properties of the product.²

Exposure to 50°C (122°F) for 3 Days

Following exposure to 50°C (122°F) for 3 days, there was no observed adverse effect on the biochemical and physical properties of REMICADE.  No differences following exposure and return to the recommended temperature range of 2°C to 8°C (36°F to 46°F) for 28 months were observed by the stability-indicating assay for visible particles.  No significant increase in visible particle content was observed following exposure to 50°C (122°F) for 3 days or at the 28-month time point after exposure.²

Exposure to 30°C (86°F) and 75% Relative Humidity for 6 Months

An additional investigation was conducted to evaluate the stability of unreconstituted REMICADE at 30ºC (86ºF) and relative humidity up to 75% after removal from the recommended storage temperature of 2ºC to 8ºC (36ºF to 46ºF). The vials were not returned to refrigeration at any time during this investigation. All predefined stability criteria were met indicating that the vials may be stored for up to 6 months at temperatures up to 30ºC (86ºF) and relative humidity up to 75%, but not exceeding the original expiration date.³

Exposure to 2°C to 8°C (36°F to 46°F) for 36 Months

REMICADE final lyophilized product (FLP) stored within the recommended storage temperature range of 2°C to 8°C (36°F to 46°F) for 36 months met all product specifications.⁴

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases was conducted on 14 June 2023.