Use aseptic technique.REMICADE vials do not contain antibacterial preservatives.
Therefore, the vials after reconstitution should be used immediately, not re-entered or stored.
The diluent to be used for reconstitution is 10 mL of Sterile Water for Injection, USP.
The total dose of the reconstituted product must be further diluted to 250 mL with 0.9% Sodium Chloride Injection, USP.
The infusion concentration should range between 0.4 mg/mL and 4 mg/mL.
The REMICADE infusion should begin within 3 hours of preparation.Calculate the dose and the number of REMICADE vials needed.
Each REMICADE vial contains 100 mg of infliximab.
Calculate the total volume of reconstituted REMICADE solution required.Reconstitute each REMICADE vial with 10 mL of Sterile Water for Injection, USP, using a syringe equipped with a 21-gauge or smaller needle.
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 opaque particles, discoloration, or other foreign particles are present.Dilute the total volume of the reconstituted REMICADE solution dose to 250 mL with 0.9% Sodium Chloride Injection, USP, by withdrawing a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of reconstituted REMICADE from the 0.9% Sodium Chloride Injection, USP, 250 mL bottle or bag.
Slowly add the total volume of reconstituted REMICADE solution to the 250 mL infusion bottle or bag.
Gently mix.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 ?m or less).
Any unused portion of the infusion solution should not be stored for reuse.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.Parenteral drug products should be inspected visually 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.
REMICADE at doses >5 mg/kg should not be administered to patients with moderate to severe heart failure.
In a randomized study evaluating REMICADE in patients with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV), REMICADE treatment at 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure (see WARNINGS and ADVERSE REACTIONS, Patients with Heart Failure).REMICADE should not be re-administered to patients who have experienced a severe hypersensitivity reaction to REMICADE.Additionally, REMICADE should not be administered to patients with known hypersensitivity to inactive components of the product or to any murine proteins.
(See Boxed WARNINGS)Serious infections, including sepsis and pneumonia, have been reported in patients receiving TNF-blocking agents.
Some of these infections have been fatal.
Although some of the serious infections in patients treated with REMICADE have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infections, some patients who were hospitalized or had a fatal outcome from infection were treated with REMICADE alone.REMICADE should not be given to patients with a clinically important, active infection.
Caution should be exercised when considering the use of REMICADE in patients with a chronic infection or a history of recurrent infection.
Patients should be monitored for signs and symptoms of infection while on or after treatment with REMICADE.
New infections should be closely monitored.
If a patient develops a serious infection, REMICADE therapy should be discontinued (see ADVERSE REACTIONS: Infections).Cases of tuberculosis, histoplasmosis, coccidioidomycosis, listeriosis, pneumocystosis, other bacterial, mycobacterial and fungal infections have been observed in patients receiving REMICADE.
Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection.
Treatment of latent tuberculosis infections should be initiated prior to therapy with REMICADE.
When tuberculin skin testing is performed for latent tuberculosis infection an induration size of 5 mm or greater should be considered positive, even if vaccinated previously with Bacille Calmette-Guerin (BCG).Patients receiving REMICADE should be monitored closely for signs and symptoms of active tuberculosis, particularly since tests for latent tuberculosis infection may be falsely negative.
The possibility of undetected latent tuberculosis should be considered, especially in patients who have immigrated from or traveled to countries with a high prevalence of tuberculosis or had close contact with a person with active tuberculosis.
All patients treated with REMICADE should have a thorough history taken prior to initiating therapy.
Some patients who have previously received treatment for latent or active tuberculosis have developed active tuberculosis while being treated with REMICADE.
Anti-tuberculosis therapy should be considered prior to initiation of REMICADE in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Anti-tuberculosis therapy prior to initiating REMICADE should also be considered in patients who have several or highly significant risk factors for tuberculosis infection14 and have a negative test for latent tuberculosis.
The decision to initiate anti-tuberculosis therapy in these patients should only be made following consultation with a physician with expertise in the treatment of tuberculosis and taking into account both the risk for latent tuberculosis infection and the risks of anti-tuberculosis therapy.For patients who have resided in regions where histoplasmosis or coccidioidomycosis is endemic, the benefits and risks of REMICADE treatment should be carefully considered before initiation of REMICADE therapy.Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF?-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Because of the nature of the adverse events seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF?-blocking agents.Therefore, the combination of REMICADE and anakinra is not recommended.