SUMMARY

• STELARA solution for intravenous infusion must be infused by a healthcare professional only and is given as an induction therapy for the treatment of Crohn’s disease and ulcerative colitis. It is to be diluted prior to intravenous infusion and administered over at least 1 hour according to the DOSAGE AND ADMINISTRATION section of the STELARA full Prescribing Information.¹

PRESCRIBING INFORMATION

DOSAGE AND ADMINISTRATION

Preparation and Administration of STELARA 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn’s disease and Ulcerative Colitis)

STELARA solution for intravenous infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.¹

1. Calculate the dose and the number of STELARA vials needed based on patient weight (Table Initial Intravenous Dosage of STELARA in the full Prescribing Information). Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
2. Withdraw, and then discard a volume of the 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL). Alternatively, a 250 mL infusion bag containing 0.45% Sodium Chloride Injection, USP may be used.
3. Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Gently mix.
4. Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discoloration or foreign particles are observed.
5. Infuse the diluted solution over a period of at least 1 hour. Once diluted, the infusion should be completely administered within eight hours of the dilution in the infusion bag.
6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
7. Do not infuse STELARA concomitantly in the same intravenous line with other agents.
8. 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.