DOSING
FOR SKYRIZI

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Dosing Schedule
IL-23i Dosing

Consistent 6 Maintenance Doses per Year After Induction

DOSING SCHEDULE

SKYRIZI dosing schedule for Crohn's disease and ulcerative colitis. Crohn's disease induction may be administered as 720 mg subcutaneous doses at Weeks 0, 2, 4, and 8, or intravenous doses of 600 mg at Weeks 0, 4, and 8. Ulcerative colitis induction is administered as 1200 mg intravenous doses at Weeks 0, 4, and 8. The first maintenance dose is given 4 weeks after the last induction dose, followed by maintenance dosing with the OBI every 8 weeks at Weeks 12, 20, 28, 36, 44, and 52 using 180 mg or 360 mg subcutaneous doses.

ADMINISTRATION CONSIDERATIONS: SKYRIZI is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject OBI subcutaneously after training in proper technique. See Instructions for Use for detailed information on administering SKYRIZI OBI.1

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LAB MONITORING Treatment Considerations in Crohn's Disease and UC1
Perform Lab Tests for1: Liver enzymes*, bilirubin
Check lab values Treatment should NOT be INITIATED or CONTINUED if: Additional considerations
Evaluate at baseline and during induction (for at least 12 weeks). Monitor thereafter according to routine patient management.

Drug-induced liver injury is suspected, until this diagnosis is excluded.

Consider other treatment options in patients with evidence of liver cirrhosis.

Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.

Infections: SKYRIZI may increase the risk of infections. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, monitor the patient closely and do not administer SKYRIZI until the infection resolves.

Consider evaluating patients for tuberculosis infection prior to initiating treatment with SKYRIZI based on clinical judgment.

Vaccinations:Complete all age-appropriate vaccinations according to current immunization guidelines prior to initiating treatment with SKYRIZI.

*Liver enzymes include ALT and AST.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; IV=intravenous; SC=subcutaneous.

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Dosing and Monitoring Guide

Quick access to dosing- and monitoring-related information as you get your patients started on SKYRIZI.

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IL-23i DOSING

SKYRIZI Offers the Same Maintenance Schedule and OBI Device, Regardless of Indication or Dosage Strength1-3

SKYRIZI requires just 6 maintenance doses per year* regardless of dosage strength to treat Crohn’s or UC1-3

(After induction doses, OBI doses in Years 1 and 2)

Over a 3-year maintenance period, SKYRIZI Q8W maintenance dosing with the OBI could result in
~20 to 60 fewer injections

compared to IL-23i Q4W maintenance dosing treatment options1-3

Dosing Schedules for IL-23 Inhibitors in Adults With Moderate to Severe Crohn's Disease1-3

Comparison of one year of maintenance dosing schedules after induction for SKYRIZI, guselkumab, and mirikizumab. SKYRIZI maintenance consists of 180 mg or 360 mg subcutaneous dosing every 8 weeks beginning at Week 12, resulting in 6 maintenance doses per year. Guselkumab maintenance is administered either every 4 weeks for 13 doses per year or every 8 weeks for 6 doses per year. Mirikizumab maintenance is administered every 4 weeks, resulting in 13 doses per year.

This presentation is not intended to compare the efficacy or safety of the treatments shown. While these factors are important, there are additional considerations for selecting a treatment. Please refer to each product’s Prescribing Information for additional information.

Please see SKYRIZI administration considerations.

*In Crohn’s, inject 300 mg subcutaneously (given as 2 consecutive injections of 100 mg and 200 mg in any order).3

†Inject 200 mg subcutaneously (given as 2 consecutive injections of 100 mg each).3

IL-23i=interleukin-23 inhibitor; IV=intravenous; OBI=on-body injector; Q4W=every 4 weeks; Q8W=every 8 weeks; SC=subcutaneous; UC=ulcerative colitis.

Injection site reaction was the most common adverse reaction reported during SKYRIZI Crohn's and UC maintenance trials.

LAB MONITORING: Evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded.

ADMINISTRATION CONSIDERATIONS: SKYRIZI is intended for use under the guidance and supervision of a healthcare professional (HCP). SKYRIZI vial for intravenous administration is intended for administration by an HCP. Prior to starting therapy, please refer to the Dosage and Administration section of the Prescribing Information for complete information on how to initiate, prepare, and administer SKYRIZI. Patients may self-inject SKYRIZI using the on-body injector with prefilled cartridge after training in subcutaneous injection technique. Provide proper training on all the required steps to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI according to the Instructions for Use.1

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