- For US Healthcare Providers
- Full Prescribing Information
INFUSION ADMINISTRATION INSTRUCTIONS
SIMPONI ARIA® solution for IV infusion should be diluted by a healthcare professional using aseptic technique as follows:
1. Calculate
SIMPONI ARIA® dosing calculator to calculate the recommended dosage of SIMPONI ARIA® based on patient weight.
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
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
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®.
Dilute the total volume of the- 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.