Stelara Caution For Usage

Incompatibilities: Not applicable.
Instructions for dilution of STELARA 130 mg for IV infusion (Crohn's disease and ulcerative colitis): 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 STELARA vials needed based on patient's body weight (see Table 33). Each 26 mL vial of 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 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, 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 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 solution may be stored for up to four hours prior to infusion.
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. 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 for up to 4 hours at room temperature up to 25°C. Do not freeze. Discard any unused portion of the infusion solution.
Special Precautions for Disposal and Other Handling: Solution for Injection for Subcutaneous Administration (Pre-filled Syringe): The solution in the STELARA pre-filled syringe should not be shaken. The solution should be visually inspected for particulate matter or discoloration prior to subcutaneous administration. The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein. This appearance is not unusual for proteinaceous solutions. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present. Before administration, STELARA should be allowed to reach room temperature (approximately half an hour). Detailed instructions for use are provided in the package leaflet.
STELARA does not contain preservatives; therefore any unused product remaining in the syringe should not be used. STELARA is supplied as a sterile, single-use syringe. The syringe and needle must never be re-used. Any unused product or waste material should be disposed of in accordance with local requirements.
Concentrate for Solution for Intravenous Infusion (Single-use Vial): Following administration of 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.