Who can administer
May be administered by registered competent doctor or nurse/midwife
Important information
- Consider premedication (antihistamine and/or paracetamol) if infusion-related reactions are anticipated (ref 1)
- In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded
- Confirm patient does not have a history of current or recent infection, or recent exposure to chicken pox or TB
- Immunisations
- Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines
- If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab
- Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment
Available preparations
Skyrizi 600 mg per 10mL vial
Reconstitution
Already in solution
Dilute further prior to administration
Infusion fluids
Sodium chloride 0.9% or Glucose 5%
Methods of intravenous administration
Intermittent intravenous infusion (using an electronically controlled infusion device)
- This is a monoclonal antibody. Reduce direct handling to a minimum and wear appropriate personal protective equipment. (ref 1)
- Prepare and administer according to the following table
Indication |
Intravenous induction dose |
Number of 600mg/10mL vials |
Volume of infusion fluid |
Infusion duration |
Crohn's disease |
600mg |
1 |
100, 250 or 500mL |
at least 60 minutes |
Ulcerative colitis |
1200mg |
2 |
250 or 500mL |
at least 120 minutes |
Do not shake the solution in the vial or in the infusion bag |
|
Dose in adults
Crohn's disease
- Give 600mg at week 0,4 and 8
- Change to subcutaneous injection thereafter - see manufacturer's instructions for doses
Ulcerative colitis
- Give 1200mg at week 0,4 and 8
- Change to subcutaneous injection thereafter - see manufacturer's instructions for doses
Renal or hepatic impairment
- No dose adjustment required
Storage
Store between 2 and 80C
References
SPC July 2024
1: Injectable medicines guide, Medusa, Downloaded Oct 2024
Therapeutic classification
Immunosuppressant, interleukin inhibitor