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.
