Parenteral Manual

Ustekinumab

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
STELARA
Classification: 
Human IgG1k monoclonal antibody
Original Date: 
March 2018
Revised Date: 
December 2019
Indications: 
  • 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.

Reconstitution and Stability: 
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 bag at room temperature up to 4 hours. Infusion should begin within 3 hours of preparation.
  • Do not use if solution has discoloration, opaque particles or any foreign material observed.
Compatibility: 

-  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

Administration: 

(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

 

Dosage: 

(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

 

Potential hazards of parenteral administration: 
  • 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.
Notes: 
  • 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.

 

References: 
  • 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.

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