INFUSION ADMINISTRATION INSTRUCTIONS¹

SIMPONI ARIA^® solution for IV infusion should be diluted by a healthcare professional using aseptic technique as follows:

Calculate

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.

Examine

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.

Dilute

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

Inspect

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

Caution

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

Warning

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.