REMICADE® DOSING AND ADMINISTRATION

REMICADE® dosing is weight based and indication specific. Both induction and maintenance doses are administered by intravenous infusion over a period of not less than 2 hours.

Preparation and Administration of REMICADE® for IV Infusion1

REMICADE® is supplied as 100 mg lyophilized infliximab in a 20 mL vial. 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. REMICADE® is administered by intravenous infusion over a period of not less than 2 hours.

1. Calculate the dose, total volume of reconstituted REMICADE® solution required and the number of REMICADE® vials needed based on the patient’s weight and indication. 

2. Reconstitute each REMICADE® vial with 10 mL of Sterile Water for Injection, USP, using a syringe equipped with a 21-gauge or smaller needle as follows:

 • Remove the flip-top from the vial and wipe the top with an alcohol swab. Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. 

• Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual. 

• 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. 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. Do not dilute the reconstituted REMICADE® solution with any other diluent. Slowly add the total volume of reconstituted REMICADE® solution to the 250 mL infusion bottle or bag. Gently mix. The resulting infusion concentration should range between 0.4 mg/mL and 4 mg/mL.

4. The REMICADE® infusion should begin within 3 hours of reconstitution and dilution. The infusion 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). REMICADE® vials do not contain preservatives. Therefore, any unused portion of the infusion solution should be discarded and not be stored for reuse. 

5. REMICADE® should not be infused concomitantly in the same intravenous line with other agents. 

6. Parenteral drug products should be inspected visually before and after reconstitution for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particulates are observed, the solution should not be used.