Summary

• SIMPONI ARIA solution for intravenous infusion should be diluted by a healthcare professional using aseptic technique.¹
• Prior to dilution, 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.¹
• Prior to infusion, visually inspect the diluted SIMPONI ARIA solution for particulate matter or discoloration. Do not use if these are present.¹
• Do not store any unused portion of the infusion solution for reuse. The infusion solution can be stored for 4 hours at room temperature.¹

PRODUCT LABELING

DESCRIPTION

The SIMPONI ARIA drug product is a sterile solution of the golimumab antibody supplied in a 4 mL glass vial for intravenous infusion.¹

SIMPONI ARIA is a preservative-free, colorless to light yellow solution with a pH of approximately 5.5. SIMPONI ARIA is not made with natural rubber latex. Each 4-mL vial of SIMPONI ARIA contains 50 mg golimumab, L-histidine (1.14 mg), L-histidine monohydrochloride monohydrate (6.42 mg), polysorbate 80 (0.6 mg), sorbitol (180 mg), and water for injection.¹

HOW SUPPLIED/STORAGE AND HANDLING

Storage and Stability

SIMPONI ARIA must be refrigerated at 36ºF to 46ºF (2ºC to 8ºC) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.¹

If needed, SIMPONI ARIA may be stored at room temperature up to 77°F (25°C) for a maximum single period of 30 days in the original carton to protect from light. Once SIMPONI ARIA has been stored at room temperature, do not return the product to the refrigerator. If not used within 30 days at room temperature, discard SIMPONI ARIA.¹

DOSAGE AND ADMINISTRATION

Important Administration Instructions

SIMPONI ARIA solution for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:¹

1. Calculate the dosage and the number of SIMPONI ARIA vials needed based on the recommended adult dosage of 2 mg/kg and the patient’s weight for rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Calculate the dosage and number of SIMPONI ARIA vials needed based on the recommended pediatric dosage of 80 mg/m² and the patient’s body surface area (BSA), for polyarticular Juvenile Idiopathic Arthritis (pJIA) and pediatric patients with PsA. Each 4 mL vial of SIMPONI ARIA contains 50 mg of golimumab.
2. Check that the solution in each vial is colorless to light yellow. The solution may develop a few fine transluscent 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% Sodium Chloride Injection, USP to a final volume of 100 mL. For example, this can be accomplished by withdrawing a volume of the 0.9% Sodium Chloride Injection, USP 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. Alternatively, SIMPONI ARIA can be diluted using the same method described above with 0.45% Sodium Chloride Injection, USP.
4. Prior to infusion, visually inspect the diluted SIMPONI ARIA solution for particulate matter or discoloration. Do not use if these are present.
5. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.22 micrometer or less).
6. Do not infuse SIMPONI ARIA concomitantly in the same intravenous line with other agents. No physical biochemical compatibility studies have been conducted to evaluate the use of SIMPONI ARIA with other intravenous agents in the same intravenous line.
7. Infuse the diluted solution over 30 minutes.
8. Once diluted, the infusion solution can be stored for 4 hours at room temperature.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 08 August 2024.