procedure:
1. Calculate the dose, total volume of reconstituted RENFLEXIS solution required and thenumber of RENFLEXIS vials needed. Each RENFLEXIS vial contains 100 mg of the
infliximab-abda antibody.
2. Reconstitute each RENFLEXIS 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 needleinto the vial through the center of the rubber stopper and direct the stream of SterileWater for Injection, USP, to the glass wall of the vial. Gently swirl the solution byrotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorousagitation. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual.
Allow the reconstituted solution to stand for 5 minutes. The reconstituted solutionconcentration is 10 mg/mL. The solution should be colorless to light yellow andopalescent, and the solution may develop a few translucent particles as infliximab is aprotein. 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 RENFLEXIS solution dose to 250 mL withsterile 0.9% Sodium Chloride Injection, USP, by withdrawing a volume equal to the
volume of reconstituted RENFLEXIS from the 0.9% Sodium Chloride Injection, USP,250 mL bottle or bag. Do not dilute the reconstituted RENFLEXIS solution with any
other diluent. Slowly add the total volume of reconstituted RENFLEXIS solution to the250 mL infusion bottle or bag. Gently mix. The resulting infusion concentration shouldrange between 0.4 mg/mL and 4 mg/mL.
4. The RENFLEXIS 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 aninfusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore sizeof 1.2 μm or less). The vials do not contain antibacterial preservatives. Therefore, anyunused portion of the infusion solution should not be stored for reuse.
5. No physical biochemical compatibility studies have been conducted to eva luate thecoadministration of RENFLEXIS with other agents. RENFLEXIS 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 forparticulate matter and discoloration prior to administration, whenever solution andcontainer permit. If visibly opaque particles, discoloration or other foreign particulatesare observed, the solution should not be used.
3 DOSAGE FORMS AND STRENGTHS
For injection: 100 mg vial: 100 mg infliximab-abda as a white, lyophilized powder in a 20mL vial for injection, for intravenous use.
4 CONTRAINDICATIONS
RENFLEXIS at doses > 5 mg/kg should not be administered to patients with moderate tosevere heart failure. In a randomized study eva luating infliximab in patients with moderate tosevere heart failure (New York Heart Association [NYHA] Functional Class III/IV),infliximab treatment at 10 mg/kg was associated with an increased incidence of death andhospitalization due to worsening heart failure [see Warnings and Precautions (5.5) andAdverse Reactions (6.1)].
RENFLEXIS should not be re-administered to patients who have experienced a severehypersensitivity reaction to infliximab products. Additional |
