REMICADE (infliximab) is a chimeric (part mouse, part human) monoclonal antibody that blocks activity of a key biologic response mediator called "tumor necrosis factor (TNF) alpha". The action of Remicade is to bind to and neutralize TNF-α on the cell membrane, soluble TNF- α and to destroy TNF-α producing cell, thus inhibiting inflammation. Remicade is supplied as a sterile, white lyophilized powder for intravenous infusion. It is an infusible medication that has been approved for home IV therapy, hospital outpatient administration or physician office administration.

Online Resources from the Manufacturer

• Patient Medication Guide
• Full Prescribing Information
• Infusion Record

Intravenous Injection Pre-Infusion Checklist

1. Tuberculosis Screening
   • Verify latent tuberculosis infection screening has been performed
     • Detailed history of patient tuberculosis exposure risk factors
     • Confirm the following:
       • Negative tuberculin skin test/PPD (<5mm induration) and/or Negative Interferon Gamma Release Assay (Quantiferon or T.Spot.TB test)
         • Consider chest x-ray in patients with TB risk factors but negative screening tests
           -OR-
       • Positive tuberculin skin test/PPD or positive Quantiferon/T.Spot.TB test with negative chest x-ray
         • Consider infectious disease consult and/or treating with INH if tuberculosis history risk factors are present (TB may be in other tissue and may have negative chest x-ray)
           -OR-
       • Patient is at least 4 weeks post initiation of INH
   • Consider repeating screening tests if patient has had recent travel to TB endemic country or change in risk factors for TB exposure
2. Confirm negative hepatitis B (particularly HepB Surface Antigen)
3. If patient has moderate to severe heart failure doses >5mg/kg are contraindicated
4. Evaluate patient for: (review affirmative answers with ordering provider)
   • Any current or recent bouts of fever, illness or infection
   • Taking any antibiotics
   • Recent or upcoming surgeries
   • Recent or planned live virus vaccinations (live virus vaccinations are not recommended during therapy with Remicade)

Vital Signs Monitoring

Obtain vital signs (patient temperature, blood pressure and pulse) upon arrival, after start of medication, upon discontinuing infusion and before the patient departs the facility. However, if prior history of an acute infusion reaction, monitor vitals every 10 minutes for 30 minutes then every 30 minutes and for 30 minutes after infusion.

Review Orders and Obtain IV Access

1. FDA-Approved Indications and Dosing (see full prescribing information for details:
   • Rheumatoid Arthritis: 3mg/kg to 10mg/kg
   • Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis, Ulcerative Colitis, Pediatric Crohn's Disease: 5mg/kg
   • Crohn's Disease: 5 mg/kg (10mg/kg may be considered if initial response is lost); Pediatric Crohn's Disease: 5 mg/kg
   • Treatment at weeks 0, 2 and 6 then every 4 to 8 weeks depending on diagnosis.
2. Prime filtered tubing (20 drops/mL) with normal saline (NS). Start IV using aseptic technique and begin infusing with 100mL NS bag; set rate to TKO. Check for pre-medication orders. Give pre-medications if ordered. Pre-medication could include antihistamines, acetaminophen and/or corticosteroids.
3. ***Do not reconstitute vials until after successfully obtaining intravenous access***

Drug Preparation

REMICADE is intended for use under the guidance and supervision of a physician. The reconstituted infusion solution should be prepared by a trained medical professional using aseptic technique by the following procedure:

1. Calculate the dose per providers order, total volume of reconstituted REMICADE solution required and the number of REMICADE vials needed. Each REMICADE vial contains 100 mg of the infliximab antibody.
2. Reconstitute each REMICADE vial with 10 mL of Sterile Water using a syringe equipped with a 21-gauge or smaller needle as follows:
   1. Remove the flip-top from the vial and wipe the top with an alcohol swab.
   2. Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water gently to the glass wall of the vial.
   3. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation.
   4. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual.
   5. Allow the reconstituted solution to stand for 5 minutes. The solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles as infliximab is a protein.
   6. Do not use if the lyophilized cake has not fully dissolved or if opaque particles, discoloration, or other foreign particles are present.
    
3. Dilute the total volume of the reconstituted REMICADE solution dose to 250 mL with sterile 0.9% Sodium Chloride Injection, USP, by withdrawing a volume equal to the volume of reconstituted REMICADE from the 0.9% Sodium Chloride Injection, USP, 250 mL bottle or bag.
4. Slowly add the total volume of reconstituted REMICADE solution to the 250 mL infusion bottle or bag. Gently mix.
5. The infusion solution must be administered over a period of not less than 2 hours and must use an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 μm or less). The vials are single use and do not contain antibacterial preservatives. Therefore, any unused portion of the infusion solution should not be stored for reuse.
6. No physical biochemical compatibility studies have been conducted to evaluate the co-administration of REMICADE with other agents. REMICADE should not be infused concomitantly in the same intravenous line with other agents.

Standard Infusion Checklist

1. 40cc/hr x 15 minutes
2. 80cc/hr x 30 minutes
3. 160cc/hr for the duration of infusion
4. Push 20cc NS flush into bag once bag is nearly empty to clear all medication in the IV tubing.
 
5. Total infusion time is 2 hours, plus 15 minutes for the flush.

Managing Acute Infusion Reactions

Acute infusion reaction can occur during the administration of this agent. If patient reports mild reactions (such as flushing, chills, etc.), slow down the infusion rate and assess patient. For more severe reactions (such as hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, fever, chills or anaphylaxis) or where mild reactions persist, stop the infusion and treat the acute reaction. Then notify the supervising provider immediately to coordinate next plan of action. For mild reactions, consider adding additional pre-medications for subsequent doses.

Updated July 2012 - ARHP Practice Committee

Disclaimer:
The information contained in this biologic reference guide is offered solely for purposes of providing health care professionals with a quick and initial reference. Before prescribing or administering any drug contained in this biologic reference guide, health professionals should read the manufacturer's complete prescribing information in order to be informed of the various clinical considerations to be taken into account.

The American College of Rheumatology is providing this information as a benefit and service in furtherance of its educational mission. By providing this information, ACR is not endorsing or recommending any of the listed companies or any of their drugs or other products. The information contained in the biologic reference guides reflect the conclusions of the individual companies and not those of the ACR which specifically disclaims any responsibility or liability for the use of such information and/or for the performance of any of the drugs listed in this biologic reference guide.