What is the recommended administration route for Skyrizi (Risankizumab) 600mg?

Skyrizi 600mg Vial Administration

Skyrizi 600mg vials are administered exclusively by intravenous (IV) infusion, not by subcutaneous injection—this formulation is specifically designed for induction therapy in Crohn's disease and ulcerative colitis. 1

Approved Indications for IV Administration

The 600mg/10mL vial formulation is FDA-approved for:

• Crohn's disease induction: 600mg IV at weeks 0,4, and 8 1
• Ulcerative colitis induction: 1,200mg IV (requiring two vials) at weeks 0,4, and 8 1

Detailed IV Infusion Protocol

Preparation Steps

• Dilution required: Withdraw 10mL from the vial (600mg) and inject into an IV infusion bag or glass bottle containing either 5% Dextrose Injection or 0.9% Sodium Chloride Injection 1
• Final concentration: Approximately 1.2 mg/mL to 6 mg/mL 1
• Volume of diluent:
  • For 600mg dose (Crohn's): Use 100mL, 250mL, or 500mL of diluent 1
  • For 1,200mg dose (ulcerative colitis): Use 250mL or 500mL of diluent 1
• Discard unused solution: Any remaining solution in the vial must be discarded after withdrawal 1

Administration Requirements

• Infusion duration:
  • Minimum 1 hour for 600mg dose 1
  • Minimum 2 hours for 1,200mg dose 1
• Healthcare provider administration: This formulation is intended for administration by a healthcare provider using aseptic technique 1
• Dedicated IV line: Do not administer concomitantly in the same IV line with other medications 1

Storage and Handling

• Immediate use preferred: Use the prepared infusion immediately after dilution 1
• Refrigerated storage: If not used immediately, store diluted solution refrigerated at 36°F to 46°F (2°C to 8°C), protected from light, for up to 20 hours 1
• Room temperature storage: After preparation or removal from refrigeration, can be stored at room temperature up to 77°F (25°C) for 4 hours cumulative (from start of dilution to start of infusion), protected from sunlight 1
• Do not shake: Avoid shaking the vial or diluted solution 1
• Do not freeze: Never freeze the diluted solution 1

Critical Safety Considerations

Pre-Treatment Requirements

• Liver function testing: Obtain liver enzymes and bilirubin levels before initiating IV risankizumab for inflammatory bowel disease 1
• Tuberculosis screening: Evaluate all patients for TB infection prior to treatment 1
• Vaccination status: Complete all age-appropriate vaccinations per current immunization guidelines before starting therapy 1

Visual Inspection

• Expected appearance: Colorless to slightly yellow, clear to slightly opalescent solution 1
• Acceptable particles: May contain a few translucent to white particles 1
• Rejection criteria: Do not use if solution contains large particles, is cloudy, or is discolored 1

Common Pitfalls to Avoid

• Wrong route error: The 600mg vial is NOT for subcutaneous administration—only IV infusion 1
• Infusion rate: Do not infuse faster than the minimum required time (1-2 hours depending on dose) 1
• Mixing medications: Never combine with other medications in the same IV line 1
• Storage violations: Exceeding the 4-hour room temperature limit or 20-hour refrigerated limit requires discarding the solution 1

Transition to Maintenance Therapy

After completing IV induction (weeks 0,4, and 8), patients transition to subcutaneous maintenance therapy:

• Maintenance dosing: 180mg or 360mg subcutaneously at week 12, then every 8 weeks 1
• Different formulation: Maintenance uses prefilled cartridges with on-body injector (180mg or 360mg), not the 600mg vial 1