Ixifi Caution For Usage

Incompatibilities: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of IXIFI with other agents. IXIFI should not be infused concomitantly in the same IV line with other agents.
Special precautions for disposal and other handling: Reconstitution, Dilution and Administration Instructions: IXIFI 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: 1. Calculate the dose, total volume of reconstituted IXIFI solution required and the number of IXIFI vials needed. More than one vial may be needed for a full dose.
2. Reconstitute each 100 mg IXIFI vial with 10 mL of Sterile Water for Injection, 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, 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 concentration is approximately 10 mg/mL. The solution should be colorless to light yellow or light brown and opalescent, and the solution may develop a few translucent particles as infliximab 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. Following reconstitution with 10 mL of Sterile Water for Injection, the resulting pH is approximately 6. Do not store unused reconstituted IXIFI solution.
3. Dilute the total volume of the reconstituted IXIFI solution to 250 mL* with sterile 0.9% Sodium Chloride Injection, (do not dilute with any other diluent) as follows: Withdraw a volume from the 0.9% Sodium Chloride Injection, 250 mL bottle or bag equal to the total volume of reconstituted IXIFI required for a dose. Slowly add the total volume of reconstituted IXIFI solution from the vial(s) to the 250 mL infusion bottle or bag.
Discard any unused portion of the reconstituted IXIFI 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.
*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.
4. The IXIFI infusion should begin within 3 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).
5. Given that the vials do not contain antibacterial preservatives, discard any unused portion of the infusion solution (do not store for reuse).
6. Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.