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SIMPONI ARIA® (golimumab) Infusion Administration Instructions | HCP

INFUSION ADMINISTRATION INSTRUCTIONS

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

1. 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.

2. 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.

3. 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

4. Inspect

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

5. 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).

6. 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.

7. Infuse

Infuse the diluted solution over a period of 30 minutes.

8. Storage

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

Please see the full Prescribing Information for SIMPONI ARIA® for administration instructions.