What is the recommended dose of Skyrizi (risankizumab) for an adult with ulcerative colitis (UC)?

Recommended Dosage of Skyrizi (Risankizumab) for Ulcerative Colitis in Adults

For adult patients with ulcerative colitis, the recommended dosage of Skyrizi (risankizumab) is 1,200 mg administered by intravenous infusion at Weeks 0,4, and 8 for induction, followed by maintenance dosing of 180 mg or 360 mg administered subcutaneously at Week 12 and every 8 weeks thereafter. 1

Detailed Dosing Information

Induction Phase

• Dose: 1,200 mg intravenous infusion
• Schedule: Weeks 0,4, and 8
• Administration: Infusion should be given over a period of at least two hours
• Preparation: Requires 2 vials of 600 mg/10 mL, diluted in 250 mL or 500 mL of 5% Dextrose or 0.9% Sodium Chloride Injection

Maintenance Phase

• Dose: 180 mg or 360 mg subcutaneous injection
• Schedule: Starting at Week 12, then every 8 weeks
• Administration: Subcutaneous injection using prefilled cartridge with On-Body Injector
• Recommendation: Use the lowest effective dosage needed to maintain therapeutic response

Pre-Treatment Requirements

Before initiating Skyrizi for ulcerative colitis, the following steps are necessary 1:

• Obtain liver enzymes and bilirubin levels
• Evaluate patients for tuberculosis (TB) infection
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines

Clinical Evidence and Rationale

The 2024 AGA Living Clinical Practice Guidelines strongly recommend risankizumab for adult outpatients with moderate-to-severe UC, based on moderate to high certainty evidence 2. Risankizumab is included among the recommended biologics for UC treatment alongside infliximab, golimumab, vedolizumab, tofacitinib, upadacitinib, ustekinumab, ozanimod, etrasimod, and guselkumab.

Recent network meta-analysis data from 2025 shows that risankizumab ranks highly in efficacy measures for UC treatment, particularly for:

• Induction of clinical remission (91.4% ranking)
• Induction of histological remission (89.4% ranking - highest among all treatments) 3

Administration Considerations

• The intravenous solution should be prepared using aseptic technique
• The diluted solution can be stored refrigerated (36°F to 46°F) for up to 20 hours if protected from light
• After preparation or removal from refrigeration, the solution can be stored at room temperature (up to 77°F) for up to 8 hours (protected from sunlight)
• The infusion should be completed within 8 hours after dilution 1

Monitoring and Follow-up

While specific monitoring guidelines for risankizumab in UC are not detailed in the available evidence, general principles for managing moderate-to-severe UC include:

• Regular assessment of clinical response
• Monitoring for adverse events
• Evaluation of liver function tests
• Assessment of TB risk during therapy

Potential Pitfalls and Caveats

1. Dose selection for maintenance: The FDA label specifies using "the lowest effective dosage needed to maintain therapeutic response" when choosing between 180 mg and 360 mg for maintenance 1. This requires clinical judgment based on individual patient response.

2. Combination therapy considerations: Unlike TNF antagonists, there is insufficient evidence regarding combining risankizumab with immunomodulators. The AGA guidelines note "NO RECOMMENDATION in favor of, or against; using non-TNF antagonist biologic in combination with immunomodulators over non-TNF antagonist monotherapy" 2.

3. Safety profile: While the evidence for risankizumab in UC is promising, clinicians should remain vigilant for potential adverse events, including injection site reactions, infections, and liver function abnormalities.