Ustekinumab intravenous for adults

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
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

• Levels may be monitored - see below

Storage

Store between 2 and 8 C

Do not freeze

References

SPC 09/03/2021

Therapeutic classification

Immunosuppressant, monoclonal antibody