Stelara Caution For Usage

Incompatibilities: Not applicable.
Instructions for Use, Handling and Disposal: Following administration of Ustekinumab (Stelara), discard any unused portion. The syringe should be disposed of with accepted medical practices for used syringes. The syringe, needle and vial must never be re-used.
Instructions for dilution of Ustekinumab (Stelara) 130 mg for IV infusion (Crohn's disease): Ustekinumab (Stelara) 130 mg solution must be diluted and prepared for IV infusion by a healthcare professional using aseptic technique.
1. Calculate the dose and the number of Ustekinumab (Stelara) vials needed based on patient's body weight (see Table 29 under Dosage & Administration). Each 26 mL vial of Ustekinumab (Stelara) contains 130 mg of ustekinumab.
2. Withdraw and then discard a volume of the 0.9% w/v sodium chloride solution from the 250 mL infusion bag equal to the volume of Ustekinumab (Stelara) to be added. (Discard 26 mL sodium chloride for each vial of Ustekinumab (Stelara) needed, for 2 vials-discard 52 mL, for 3 vials- discard 78 mL, for 4 vials- discard 104 mL). Alternatively, a 250 mL infusion bag containing 0.45% w/v sodium chloride solution may be used.
3. Withdraw 26 mL of Ustekinumab (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 administration. Do not use if visibly opaque particles, discoloration or foreign particles are observed.
5. Administer the diluted solution over a period of at least one hour. Once diluted, the infusion should be completed 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 Ustekinumab (Stelara) concomitantly in the same intravenous line with other agents.
8. Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.
Storage: If necessary, the diluted infusion solution may be stored at room temperature. The infusion should be completed within 8 hours of the dilution in the infusion bag. Do not freeze. Discard any unused portion of the infusion solution.