INFUSION ADMINISTRATION INSTRUCTIONS

1 Calculate the dosage and the number of SIMPONI ARIA^® vials needed based on the recommended dosage of 2 mg/kg and the patient’s weight. Each single-use 4-mL vial of SIMPONI ARIA^® contains 50 mg of golimumab. You may refer to the
SIMPONI ARIA^®dosing calculator to calculate the recommended dosage of SIMPONI ARIA^® based on patient weight.

2 Check that the solution in each vial is colorless to light yellow. The solution may develop a few fine translucent particles, as golimumab is a protein. Do not use if opaque particles, discoloration, or other foreign particles are present.

3 Dilute the total volume of the SIMPONI ARIA^® solution with 0.9% w/v sodium chloride for infusion to a final volume of 100 mL. For example, this can be accomplished by withdrawing a volume of the 0.9% w/v sodium chloride solution from the 100-mL infusion bag or bottle equal to the total volume of SIMPONI ARIA^®.

• Slowly add the total volume of SIMPONI ARIA^® solution to the 100-mL infusion bag or bottle
• Gently mix
• Discard any unused solution remaining in the vials

4 Prior to infusion, visually inspect the diluted SIMPONI ARIA^® solution for particulate matter or discoloration. Do not use if these exist.

5 Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.22 micrometer µm or less).

6 Do not infuse SIMPONI ARIA^® concomitantly in the same IV line with other agents. No physical biochemical compatibility studies have been conducted to evaluate the use of SIMPONI ARIA^® with other IV agents in the same IV line.

7 Infuse the diluted solution over a period of 30 minutes.

8 Once diluted, the infusion solution can be stored for 4 hours at room temperature.