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Stability of STELARA IV Infusion Formulation After Dilution in Normal or Half Normal Saline

Last Updated: 10/07/2024

Summary

  • STELARA 130 mg/26 mL (5 mg/mL) vial for intravenous infusion does not contain preservatives. Each vial is for single use only. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements.1
  • STELARA solution for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique. It is to be diluted prior to intravenous infusion with 0.9% Sodium Chloride Injection, USP (alternatively, 0.45% Sodium Chloride Injection, USP may be used) and administered over a period of at least one hour.1
  • Once diluted, the diluted solution should be visually inspected before infusion. Do not use if visibly opaque particles, discoloration or foreign particles are observed.1
  • If necessary, the diluted infusion solution may be kept at room temperature up to 25°C (77°F) for up to 7 hours. Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 8 hours after the dilution in the infusion bag (cumulative time after preparation including the storage and the infusion period). Do not freeze. Discard any unused portion of the infusion solution.1
  • For additional information on STELARA for intravenous use, please refer to the full Prescribing Information for STELARA.1

 

References

1 STELARA (ustekinumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf.