Summary

• Information regarding infiltration is not included in the Food and Drug Administration (FDA)-approved labeling for REMICADE. The information provided below is in response to your request for information. It is not intended to make any recommendation beyond the information contained in the approved product labeling.
• In the event of injection site infiltration with REMICADE, standard precautions should be followed, including immediate discontinuation of the current infusion. The site at which infiltration occurred should be treated based on institutional guidelines and/or protocols. Assess, monitor, and treat the patient as appropriate.
• Following reconstitution of the REMICADE vial with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 7.2.¹

CHEMICAL PROPERTIES

Following reconstitution of the REMICADE vial with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 7.2.¹

An investigation was conducted to report the osmolality of REMICADE Final Lyophilized Product following reconstitution with Sterile Water for Injection, USP, and further dilution with 0.9% Sodium Chloride Injection, USP. Two vials of REMICADE were reconstituted with 10 mL each of Sterile Water for Injection, USP. Each vial was then further diluted to 250 mL with 0.9% Sodium Chloride injection, USP, to simulate the method of preparation for intravenous drug administration. The osmolality of REMICADE following reconstitution and dilution ranged from 268–272 mOsm/kg H₂O.²

INFILTRATION

The following information is not included in the Food and Drug Administration (FDA)-approved labeling for REMICADE and is provided in response to your request for information. It is not intended to make any recommendation beyond the information contained in the approved product labeling.

In the event of injection site infiltration with REMICADE, standard precautions should be followed, including immediate discontinuation of the current infusion. The site at which infiltration occurred should be treated based on institutional guidelines and/or protocols. Assess, monitor, and treat the patient as appropriate.

CLINICAL STUDIES

Clinical trials, conducted primarily in adult patients with rheumatoid arthritis (RA), Crohn’s disease (CD), ankylosing spondylitis (AS), psoriatic arthritis (PsA), plaque psoriasis, and ulcerative colitis (UC) evaluated the safety and efficacy of REMICADE in 5707 REMICADE-treated patients and 1600 placebo-treated patients.³

The majority of the data presented reflect both single and repeat-dosing regimens, including chronic maintenance therapy through as long as 102 weeks.³

Injection site infiltration was reported as an individual event in REMICADE-treated patients.  The average duration of follow-up for studies in RA, CD, AS, PsA, plaque psoriasis, and UC was 45.5 weeks for patients receiving REMICADE and 29.0 weeks for patients receiving placebo.³

In these clinical trials, patients experienced injection site infiltration in the following percentages: 1.6% vs 1.1% for the REMICADE- and placebo-treated groups, respectively.⁴ Injection site infiltration was not classified as serious in either of the treatment groups.³

The REACH (A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNFα Chimeric Monoclonal Antibody [Infliximab, infliximab] in 112 Pediatric Subjects with Moderate to Severe Crohn's Disease) trial evaluated the safety and efficacy of REMICADE in moderately to severely active pediatric CD patients. The average duration of follow-up for all patients was 47.2 weeks. In the REACH study, 4.5% of patients experienced an adverse event of injection site infiltration. There were no reports of injection site infiltration classified as serious.⁵

Additionally, a randomized, multicenter, open-label phase 3 study in 60 pediatric patients (ages 6-17 years old) with moderate to severe UC evaluated the efficacy and safety of REMICADE in this population during a 54 week trial. There were no reports of injection site infiltration in this study.^6,7

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 22 September 2023.