DOSING
FOR SKYRIZI

Consistent Dosing Your Patients Can Count On

DOSING SCHEDULE

Reliable 2-Month Maintenance Dosing After 3 IV Infusions for Crohn’s Disease and Ulcerative Colitis1

Maintenance doses administered in the office or at home1

Induction doses for SKYRIZI 600 mg IV per dose in Crohn's and SKYRIZI 1200 mg IV per dose in UC: Administer each dose over at least 1 hour in Crohn’s disease and 2 hours in ulcerative colitis at weeks 0, 4, and 8. The first maintenance dose is 4 weeks after the last induction infusion. Maintenance dose schedule: 180 mg/1.2 mL or 360 mg/2.4 mL. Use the lowest effective dosage to maintain therapeutic response at weeks 12, 20, 28, 36, 44, and 52 and every 8 weeks thereafter. On-body injector (OBI) with SKYRIZI prefilled cartridge for SC injection.

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 to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI according to the Instructions for Use.

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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.

Tuberculosis (TB): Evaluate for TB infection prior to initiating treatment with SKYRIZI.

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.

DOWNLOAD SKYRIZI DOSING GUIDE

IL-23i DOSING

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

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

1 Year of Maintenance Doses (after induction is complete). SKYRIZI risankizumab-rzaa (SC): 180 mg or 360 mg every 8 weeks for 6 per year. Induction dosing: 3 IV infusions (600 mg per dose) at weeks 0, 4, and 8. Each dose of SKYRIZI should be administered over at least 1 hour. Use the lowest effective maintenance dose to maintain therapeutic response. Mirikizumab-mrkz (SC): 300 mg every 4 weeks for 13 per year. Induction dosing: 3 IV infusions (900 mg per dose) at Weeks 0, 4, and 8. Guselkumab (SC): 100 mg every 8 weeks for 6 per year or 200 mg every 4 weeks for 13 per year. Induction dosing: 3 IV infusions (200 mg per dose) at Weeks 0, 4, and 8. Or SC, 400 mg per dose (2x 200 mg SC injections) at Weeks 0, 4, and 8. Use the lowest effective recommended maintenance dosage to maintain therapeutic response. Doses are shown as OBI icon for SKYRIZI and syringe icons as 100 mg pre-filled syringe or pre-filled pen, 200 mg pre-filled syringe or pre-filled pen, pre-filled pen or syringe, and injector or syringe.

*Inject 300 mg subcutaneously (given as 2 consecutive injections of 100 mg and 200 mg in any order).

IL-23=interleukin-23; IL-23i=interleukin-23 inhibitor; OBI=on-body injector; Q4W=every 4 weeks; Q8W=every 8 weeks.

Dosing Schedules for IL-23 Inhibitors in Adults With Moderate to Severe UC1-3

1 Year of Maintenance Doses (after induction is complete). SKYRIZI risankizumab-rzaa (SC): 180 mg or 360 mg every 8 weeks for 6 per year. Induction dosing: 3 IV infusions (1200 mg per dose) at weeks 0, 4, and 8. Each dose of SKYRIZI should be administered over at least 2 hours. Use the lowest effective maintenance dose to maintain therapeutic response. Mirikizumab-mrkz (SC): 200 mg every 4 weeks for 13 per year. Induction dosing: 3 IV infusions (300 mg per dose) at Weeks 0, 4, and 8. Guselkumab (SC): 100 mg every 8 weeks for 6 per year or 200 mg every 4 weeks for 13 per year. Induction dosing: 3 IV infusions (200 mg per dose) at Weeks 0, 4, and 8. Or SC, 400 mg per dose (2x 200 mg SC injections) at Weeks 0, 4, and 8. Use the lowest effective recommended maintenance dosage to maintain therapeutic response. Doses are shown as OBI icon for SKYRIZI and syringe icons as 100 mg pre-filled syringe or pre-filled pen, pre-filled pen or syringe, and injector or syringe or pre-filled pen.

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

IL-23=interleukin-23; IL-23i=interleukin-23 inhibitor; OBI=on-body injector; Q4W=every 4 weeks; Q8W=every 8 weeks.

Over a 3-year period, SKYRIZI Q8W maintenance dosing with the OBI could result in ~20 to 60 fewer injections compared to IL-23i Q4W maintenance dosing treatment options.1-3

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.

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

LAB MONITORING: Evaluate liver enzymes and billirubin 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