About This Information

This information provides a detailed overview of the dosing regimens for Skyrizi (risankizumab) based on its FDA-approved indications. It complements the Skyrizi (risankizumab) dosing calculator by offering context on administration, scheduling, and key clinical considerations. All information should be used for educational purposes and is not a substitute for professional medical advice.

Outputs Explained

The dosing schedules for Skyrizi vary significantly based on the patient's condition. The key terms used to describe the dosing outputs are:

• Indication: The specific medical condition being treated, such as Plaque Psoriasis (PsO), Psoriatic Arthritis (PsA), or Crohn's Disease (CD).
• Induction Phase: The initial dosing period designed to quickly bring the disease under control. For Crohn's Disease, this involves a series of intravenous (IV) infusions.
• Maintenance Phase: The ongoing dosing schedule that follows the induction phase, designed to maintain disease control over the long term. This typically involves subcutaneous (SC) injections.
• Route of Administration: The method of delivering the medication, either as an intravenous (IV) infusion into a vein or a subcutaneous (SC) injection under the skin.

How to Use This Guide

This guide is intended to clarify the standard dosing protocols for Skyrizi. Use the "Dosing Overview" section below to find the specific regimen for the relevant indication. Note the differences in dose, administration route, and frequency between the induction and maintenance phases, especially for Crohn's Disease. Always confirm treatment plans with the official prescribing information and a qualified healthcare provider.

Dosing Overview

The recommended dosage for Skyrizi is dependent on the indication as outlined below.

Switching Medications

Switching a patient from another biologic agent to Skyrizi requires careful clinical consideration. There is no universal protocol, and the decision should be individualized based on the previous therapy, disease activity, and patient factors. The timing of the first Skyrizi dose relative to the last dose of the prior medication should be determined by a healthcare provider to manage the risk of disease flare or adverse events.

Missed Dose Instructions

If a patient misses a dose of Skyrizi, the following guidance generally applies:

• Instruct the patient to take the missed dose as soon as they remember.
• After taking the missed dose, the next dose should be administered according to the regular schedule.
• It is crucial for patients not to take a double dose to make up for a missed one.

Patients should always be encouraged to consult their healthcare provider for specific instructions regarding a missed dose.

Safety Alerts

Skyrizi may lower the ability of the immune system to fight infections and may increase the risk of infections. Healthcare providers should test for tuberculosis (TB) before starting treatment and monitor for signs and symptoms of infection during and after treatment. Other important safety information includes the risk of hypersensitivity reactions, hepatotoxicity (in Crohn's Disease), and the need to avoid live vaccines while on treatment.

Frequently Asked Questions (FAQ)

Is the dose for Plaque Psoriasis the same as for Psoriatic Arthritis?
Yes, the recommended dose for both adult Plaque Psoriasis and Psoriatic Arthritis is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.

Why is the Crohn's Disease induction dose given by IV infusion?
The initial 600 mg doses for Crohn's Disease are given as intravenous (IV) infusions to achieve therapeutic drug levels more rapidly and establish clinical response at the start of therapy.

What is the maintenance dose for Crohn's Disease?
Following the three-dose IV induction, the maintenance dosage for Crohn's Disease is 360 mg administered as a subcutaneous injection at Week 12, and then every 8 weeks.

What are the available formulations for Skyrizi?
Skyrizi is available as a 150 mg prefilled pen or syringe for PsO/PsA, a 600 mg vial for IV infusion for CD induction, and a 360 mg on-body injector for CD maintenance.

Can a patient self-administer Skyrizi?
Yes, after proper training from a healthcare provider, patients may self-inject the 150 mg (prefilled pen/syringe) and 360 mg (on-body injector) subcutaneous doses at home.

How long does the IV infusion for Crohn's Disease take?
Each 600 mg IV induction dose should be administered over a period of at least one hour.

Are there any dosage adjustments for body weight?
No, the dosing for Skyrizi in adults is fixed and does not require adjustment based on body weight for any of the approved indications.

What should I do if a patient experiences an infection?
If a patient develops a serious infection, treatment with Skyrizi should be withheld until the infection resolves. Patients should be instructed to seek medical advice if signs or symptoms of a clinically important infection occur.

Does Skyrizi require any lab monitoring?
For Crohn's Disease patients, evaluation of liver enzymes and bilirubin is recommended at baseline and during the induction phase. Monitoring for other indications is based on clinical judgment.

References

• SKYRIZI® (risankizumab-rzaa) US Prescribing Information. AbbVie Inc. Revised: 10/2023. Accessed via FDA.gov.
• Skyrizi HCP Official Website. AbbVie Inc.
• Skyrizi European Public Assessment Report (EPAR). European Medicines Agency.
• Mease, P. J., et al. (2020). Risankizumab, an Interleukin-23 Inhibitor, for Psoriatic Arthritis: Efficacy and Safety Results From the 52-Week KEEPsAKE 1 Trial. Annals of the Rheumatic Diseases, 79(suppl 1), 121-122.