Infliximab

Administration Instructions Regarding Infusion Reactions Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity, other reactions) that occur during infusion and shortly after infusion. Prior to infusion with RENFLEXIS, patients may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids [see Warnings and Precautions ] .

For mild to moderate reactions during the infusion, consider slowing or stopping the infusion. Upon resolution of these reactions, may reinitiate at a lower infusion rate and/or with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids. Discontinue the infusion if the mild to moderate reactions reoccur.

Discontinue the infusion if severe hypersensitivity reactions occur during the infusion.

Reconstitution, Dilution, and Administration Instructions RENFLEXIS is intended for use under the guidance and supervision of a healthcare provider. The supplied lyophilized powder must be reconstituted and diluted prior to administration. The infusion solution should be prepared and administered by a trained medical professional using aseptic technique by the following procedure: Calculate the dose, total volume of reconstituted RENFLEXIS solution required and the number of RENFLEXIS vials needed.

More than one vial may be needed for a full dose. Reconstitute each 100 mg RENFLEXIS vial with 10 mL of Sterile Water for Injection, USP, to obtain a concentration of 10 mg/mL, 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, which has a cake-like appearance. 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. Visually inspect the reconstituted solution for particulate matter and discoloration.

The reconstituted solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles as infliximab-abda is a protein. Do not use if the lyophilized powder has not fully dissolved or if opaque particles, discoloration, or other foreign particles are present. Do not store unused reconstituted RENFLEXIS solution.

Dilute the total volume of the reconstituted RENFLEXIS solution to 250 mL For volumes greater than 250 mL, either use a larger infusion bag (e.g. 500 mL) or multiple 250 mL infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/mL. with sterile 0.9% Sodium Chloride Injection, USP, (do not dilute with any other diluent) as follows: Withdraw a volume from the 0.9% Sodium Chloride Injection, USP, 250 mL bottle or bag equal to the total volume of reconstituted RENFLEXIS required for a dose.

Slowly add the total volume of reconstituted RENFLEXIS solution from the vial(s) to the 250 mL infusion bottle or bag. Discard any unused portion of the reconstituted RENFLEXIS solution remaining in the vial(s). Gently invert the bag to mix the solution. The resulting infusion concentration should range between 0.4 mg/mL (minimum recommended concentration) and 4 mg/mL (maximum recommended concentration) of infliximab-abda.

The RENFLEXIS infusion should begin within 4 hours of reconstitution and dilution. The infusion must be administered intravenously for at least 2 hours with an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 μm or less). The diluted RENFLEXIS solution may be stored at room temperature at 25 °C (77°F) for up to 4 hours, including reconstitution and dilution time.

If needed, the diluted RENFLEXIS solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 34 days. After removal from refrigeration, the diluted solution may be stored at room temperature at up to 25°C (77°F) for an additional 6 hours. Given that the vials do not contain antibacterial preservatives, discard any unused portion of the infusion solution (do not store for reuse).

No physical biochemical compatibility studies have been conducted to evaluate the coadministration of RENFLEXIS with other agents. RENFLEXIS should not be infused concomitantly in the same intravenous line with other agents.