Simponi Caution For Usage

Incompatibilities: Specific drug compatibility studies have not been conducted.
Instructions for Use and Handling and Disposal: Vial: Use aseptic technique.
1. Calculate the dose and the number of SIMPONI vials needed based on patient weight. Each 4 mL vial of SIMPONI contains 50 mg of golimumab.
2. Check that the solution 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 solution dose to 100 mL with 0.9% w/v sodium chloride for infusion. This can be accomplished by withdrawing a volume of the 0.9% w/v sodium chloride solution from the 100-mL glass bottle or infusion bag equal to the volume of SIMPONI and discard the withdrawn solution. Alternatively, SIMPONI can be diluted using the same method described above with 0.45% w/v sodium chloride for infusion.
4. Slowly add the total volume of SIMPONI solution to the 100-mL infusion bottle or bag. Gently mix.
5. Visually inspect parenteral medicinal products for particulate matter or discoloration prior to administration. Do not use if visibly opaque particles, discoloration or foreign particles are observed.
6. Infuse the diluted solution over a period of 30 ± 10 minutes. The infusion of the diluted solution should be completed within 6 hours after preparation.
7. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.22 micrometer or less). Do not store any unused portion of the infusion solution for reuse.
8. No physical biochemical compatibility studies have been conducted to evaluate the co-administration of SIMPONI with other agents. Do not infuse SIMPONI concomitantly in the same intravenous line with other agents.
9. Any unused product or waste material should be disposed of in accordance with local requirements.