Stability of STELARA IV Infusion Formulation After Dilution in Normal or Half Normal Saline for Crohn’s Disease and Ulcerative Colitis

Summary

• STELARA 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 (130 mg/26 mL [5 mg/mL]) for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.¹
• Prior to administration, visually inspect STELARA for particulate matter and discoloration. STELARA is a colorless to light yellow solution and may contain a few small translucent or white particles. Do not use STELARA if it is discolored or cloudy, or if other particulate matter is present. The appropriate infusion solution for intravenous infusion in Crohn’s disease and ulcerative colitis is based on the patient population and body weight. See Table below: Appropriate Infusion Solution and Final Infusion Volumes for Intravenous Infusion of STELARA Solution for Crohn’s Disease and Ulcerative Colitis.

• The diluted solution is to be infused over a period of at least one hour. Once diluted, the infusion should be completely administered within the storage time (see Storage below).¹
• Discard any unused portion of the infusion solution.¹

Storage

• Do not freeze.¹
• Storage time at room temperature begins once the diluted solution has been prepared.¹
• 100 mL infusion bag:
  • If necessary, the diluted infusion solution may be kept at room temperature up to 25°C (77°F) for up to 3 hours.¹
  • The infusion should be completed within 4 hours after the dilution in the infusion bag (cumulative time after preparation including the storage and the infusion period).¹
• 250 mL infusion bag:
  • If necessary, the diluted infusion solution may be kept at room temperature up to 25°C (77°F) for up to 7 hours.
  • 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).¹
• For complete information on preparation and administration of STELARA 130 mg/26 mL (5 mg/mL) Vial for intravenous infusion in Crohn’s Disease and Ulcerative Colitis, please refer to the full Prescribing Information for STELARA.¹