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Crohn’s Disease
Treatment of patients with moderately to severely active Crohn’s disease, who have had inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumor necrosis factor-alpha (TNFa) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids. -
Plaque Psoriasis
Treatment of chronic moderate to severe plaque psoriasis in adolescent patients from 12 to 17 years of age, who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies. -
Use at CHEO
Treatment of children with moderately to severely active Crohn’s disease, who have had inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumor necrosis factor-alpha (TNFa) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids.
| Dose per vial | Vial Size | Final Concentration |
| 130 mg | 26 mL | 5 mg/mL |
- Available as 130 mg preservative free - single use vial at a concentration of 5 mg/mL sterile solution.
- Clear, colourless to light yellow in appearance.
- Store vials in original carton refrigerated (2 – 8ᵒC). DO NOT FREEZE.
- Protect from light.
- Always prepare dose in a 0.9% NaCl bag with a total volume of 250 mL (not smaller volume)
- Prepare exact volume bag as follows based on the dose:
- Dose = 260 mg = 2 vials - 52 mL ustekinumab, 198 mL 0.9% NaCl
- Dose = 390 mg = 3 vials - 78 mL ustekinumab, 172 mL 0.9% NaCl
- Dose = 520 mg = 4 vials - 104 mL ustekinumab, 146 mL 0.9% NaCl
- Add medication to infusion bag and gently mix
- Once diluted in 0.9% NaCl, store bags at room temperature and infusions should be completed within 8 hours.
- Do not use if solution has discoloration, opaque particles or any foreign material observed.
- Solutions compatible: 0.9% NaCl
- Additives/Above Cassette Compatible: No information
- Y-Site compatibility: No information
- Incompatible: DO NOT infuse with any other medication or solution
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | YES - 45 mg and 90 mg |
| IM | NO |
| IV Direct | NO |
| IV Intermittent Infusion |
YES - large volume pump only Usual dilution: 0.5 - 2 mg/mL Infusion time: greater than or equal to 60 minutes |
| IV Continuous Infusion | NO |
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
Crohn’s Disease:
- Induction dosing (intravenous infusion):
| Body Weight (kg) | Dose | Number of 130 mg Vials |
| ≤55 | 260 mg | 2 |
| <55 to≤ 85 | 390 mg | 3 |
| >85 | 520 mg | 4 |
- Maintenance dosing: 90 mg subcutaneous injection every 8 weeks
Pediatric:
Psoriasis:
- Should be administered at weeks 0 and 4, then every 12 weeks thereafter
| Body Weight (kg) |
Dose |
Dosage Form |
|
<60 |
0.75 mg/kg | Vial |
|
≥60 to ≤100 kg |
45 mg | Prefilled syringe, vial |
|
>100 kg |
90 mg | Prefilled syringe |
- Infusion related reactions are possible and could include, but are not limited to: anaphylaxis, hypersensitivity reactions (rash, urticaria, flushing, bronchospasm)
- Common adverse effects include: headache, nasopharyngitis, vomiting, rash, pruritus, urinary tract infection and diarrhea.
- A rare, but serious adverse effect is Reversible Posterior Leukoencephalopathy Syndrome (RPLS), characterized by seizures, headache, confusion and vision problems. Stop infusion if any of these symptoms arise during infusion, and seek immediate medical attention if occurring post-infusion.
- Increased susceptibility for the development of infections, including tuberculosis (TB). TB screening should be done prior to therapy initiation.
- Prior to therapy initiation, ensure patient has all immunizations up to date according to the public immunization guideline of their respective province of residency.
- Monitor vital signs pre-infusion, every 30 minutes during infusion and 1 hour post infusion
- Monitor patient for 1 – 2 hours post-infusion
- Infusion must be administered through a non-pyrogenic, low protein-binding 0.22 micron in-line filter
- Recommended discontinuation of therapy if no clinical/therapeutic response observed with 12 weeks of therapy.
- Feagan, B.G. et al. (2016). Ustekinumab as Induction and Maintenance Therapy for Crohn`s Disease. NEJM. 375:20.
- STELARA (Ustekinumab) Product Monograph. Janssen Inc. 2016.
- Prescribing Information Sheet – STELARA® (Ustekinumab). Janssen Inc. September 2016.