Who can administer
May be administered by registered competent doctor or nurse/midwife
Important information
- Before the administration of each dose, the patient should be examined for the presence of infection, and consideration given to delaying treatment should infection be present
- Caution in patients with a chronic infection, or a history of recurrent infection
- Prior to initiating therapy, patients should be evaluated for tuberculosis infection - see SPC
- High cost item (>2,000 EURO per vial)- take care during preparation
Available preparations
Stelara 130mg per 26ml vial (5mg/ml)
Reconstitution
Already in solution
Dilute further prior to administration
Infusion fluids
Sodium chloride 0.9%
Methods of intravenous administration
Intermittent intravenous infusion only (using an electronically controlled infusion device)
- Withdraw and discard a volume of infusion fluid from 250ml infusion bag that is equal to the volume of drug solution to be added
- For 130mg dose (1 vial)- remove and discard 26ml from the 250ml infusion bag
- For 260mg dose (2 vials)- remove and discard 52ml from the 250ml infusion bag
- For 390mg dose (3 vials)- remove and discard 78ml from the 250ml infusion bag
- For 520mg dose (4 vials)- remove and discard 104ml from the 250ml infusion bag
- Withdraw 26ml drug solution from each vial needed and add to the infusion bag, to end up with a total volume of 250ml
- Gently mix. Administer over 60 minutes
- An in-line 0.2 micron filter must be used during administration (Braun filter 0409 9303)
- UCH: available from pharmacy
- MPUH: available from stores
Dose in adults
Initial intravenous dose: Dose as per table below (equates to approximately 6mg/kg)
| Crohn's disease and Ulcerative Colitis |
| Body weight |
Recommended dose (approx 6mg/kg) |
Number of 130mg vials |
| 55kg or less |
260mg |
2 |
| 55 to 85kg |
390mg |
3 |
| over 85kg |
520mg |
4 |
Subsequent doses
- Following the initial intravenous dose, the treatment is continued with subcutaneous use
- The first subcutaneous dose should be given at week 8 following the intravenous dose (a different preparation must be used for subcut route - available as a pre-filled pen)
- See SPC for further details
Renal or hepatic impairment
- Ustekinumab has not been studied in this patient population
Monitoring
- Monitor for hypersensitivity reactions during and for an hour after the infusion (ref 1)
- Levels may be monitored - see below
Storage
Store between 2 and 8 C
Do not freeze
References
SPC 25/09/2024
1: Injectable medicines guide, downloaded from Medusa 05/02/2025
Therapeutic classification
Immunosuppressant, monoclonal antibody
