Get your patient on Skyrizi (Risankizumab-Rzaa)

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Dosage & administration

Recommended Dosage

Plaque Psoriasis and Psoriatic Arthritis:


Crohn’s Disease:


Ulcerative Colitis:


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This AI tool offers medical information for informational purposes only and is not a substitute for professional medical judgment or advice. Physicians and healthcare professionals should exercise their expertise and discretion when interpreting and applying the provided information to specific clinical situations.

Skyrizi prescribing information

Recent Major Changes
[Dosage and Administration, General Considerations for Administration 2.2]
2.2
General Considerations for Administration

• Visually inspect SKYRIZI for particulate matter and discoloration prior to administration. The solution may contain a few translucent to white particles.

○ SKYRIZI 150 mg/mL prefilled pen or prefilled syringe, 180 mg/1.2 mL prefilled syringe or prefilled cartridge, and 360 mg/2.4 mL prefilled cartridge: a colorless to yellow, and clear to slightly opalescent solution.

○ SKYRIZI 90 mg/mL prefilled syringe and 600 mg/10 mL vial: a colorless to slightly yellow, and clear to slightly opalescent solution.

○ Do not use if the solution contains large particles or is cloudy or discolored.

• Discard after use. Do not reuse.

9/2025
[Dosage and Administration, Preparation and Administration Instructions (Crohn’s Disease and Ulcerative Colitis) 2.8]
2.8 Preparation and Administration Instructions (Crohn’s Disease and Ulcerative Colitis)

Intravenous Induction Dosing Regimen:

1. SKYRIZI vial for intravenous administration is intended for administration by a healthcare provider using aseptic technique.

2. Prior to intravenous administration, determine the dose and number of SKYRIZI vials needed based on the patient’s indication (see table below). Withdraw 10 mL of SKYRIZI solution from a vial (600 mg/10 mL) and inject into an intravenous infusion bag or glass bottle containing 5% Dextrose Injection or 0.9% Sodium Chloride Injection (see

[Table 1]
Table 1. Total Volume of Diluent Required for Intravenous Induction Dose


Indication
I
ntravenous
Induction Dose
Number of SKYRIZI 600 mg/10 mL Vials
Total Volume of 5% Dextrose
or


0.9% Sodium Chloride
Injection
Crohn’s disease600 mg1100 mL, or 250 mL, or 500 mL
Ulcerative colitis1,200 mg2250 mL, or 500 mL
below) for a final concentration of approximately 1.2 mg/mL to 6 mg/mL. Discard any remaining solution in the vial.

Table 1. Total Volume of Diluent Required for Intravenous Induction Dose


Indication
I
ntravenous
Induction Dose
Number of SKYRIZI 600 mg/10 mL Vials
Total Volume of 5% Dextrose
or


0.9% Sodium Chloride
Injection
Crohn’s disease600 mg1100 mL, or 250 mL, or 500 mL
Ulcerative colitis1,200 mg2250 mL, or 500 mL

3. Infuse the diluted solution intravenously over a period of at least one hour for the SKYRIZI 600 mg dose; at least two hours for the SKYRIZI 1,200 mg dose. If stored refrigerated, allow the diluted SKYRIZI solution in the infusion bag or glass bottle to warm to room temperature prior to the start of the intravenous infusion.

4. Do not administer SKYRIZI diluted solution concomitantly in the same intravenous line with other medicinal products.

Handling and
Storage of
the Vial and the
Diluted Solution:

  • Do not shake the vial or diluted solution in the infusion bag or glass bottle.

  • Use the prepared infusion immediately. If not used immediately, store the diluted SKYRIZI solution refrigerated and protected from light for up to 20 hours between 36°F to 46°F (2°C to 8°C).

  • Immediately after preparation or removal from refrigeration, the diluted SKYRIZI solution can be stored at room temperature at up to 77°F (25°C) (protected from sunlight) for up to 8 hours. Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 8 hours after dilution in the infusion bag.

  • Exposure to indoor light is acceptable during room temperature storage and administration.

  • Do not freeze.

Subcutaneous Maintenance Dosing Regimen:

Using the single-dose 180 mg or 360 mg prefilled cartridge with On-Body Injector:

  • SKYRIZI is intended for use under the guidance and supervision of a healthcare professional.

  • 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.

  • Before using the on-body injector with prefilled cartridge, remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (45 to 90 minutes) without removing the prefilled cartridge or on-body injector from the carton.

  • Use the on-body injector to administer SKYRIZI 180 mg/1.2 mL or SKYRIZI 360 mg/2.4 mL prefilled cartridge subcutaneously on thigh or abdomen.

  • Start the injection within 5 minutes after inserting the prefilled cartridge into the On-Body Injector.

  • Do not inject into areas where the skin is tender, bruised, erythematous, indurated or affected by any lesions.

  • If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation and administration of SKYRIZI

[see
]
Instruct the patient to read the Instructions for Use before administration.

Using the 90 mg/mL
or 180 mg/1.2 mL
prefilled syringe:

• Administer each SKYRIZI 90 mg/mL or 180 mg/1.2 mL prefilled syringe subcutaneously.

• Patients may self-inject SKYRIZI after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI.

• Before injecting, remove the carton from the refrigerator and without removing the prefilled syringes from the carton, allow SKYRIZI to reach room temperature out of direct sunlight (15 to 30 minutes).

• Use the 90 mg/mL or 180 mg/1.2 mL prefilled syringe(s) to administer SKYRIZI 180 mg or SKYRIZI 360 mg subcutaneously as follows:

○ 180 mg maintenance dose:

▪ SKYRIZI 90 mg/mL prefilled syringes: Two 90 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen).

▪ SKYRIZI 180 mg/1.2 mL prefilled syringe: One 180 mg prefilled syringe is required.

○ 360 mg maintenance dose:

▪ SKYRIZI 90 mg/mL prefilled syringes: Four 90 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen).

▪ SKYRIZI 180 mg/1.2 mL prefilled syringes: Two 180 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen).

• Do not inject into areas where the skin is tender, bruised, erythematous, indurated or affected by any lesions. Administration of SKYRIZI in the upper, outer arm may only be performed by a healthcare professional or caregiver.

• If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation and administration of SKYRIZI

[see
]
Instruct the patient to read the Instructions for Use before administration.

9/2025
Indications & Usage

SKYRIZI is an interleukin-23 antagonist indicated for the treatment of:

  • [moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1.1]
    1.1 Plaque Psoriasis

    SKYRIZI®is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.



  • [active psoriatic arthritis in adults. 1.2]
    1.2 Psoriatic Arthritis

    SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.



  • [moderately to severely active Crohn's disease in adults. 1.3]
    1.3 Crohn’s Disease

    SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.



  • [moderately to severely active ulcerative colitis in adults. 1.4]
    1.4 Ulcerative Colitis

    SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Dosage & Administration

Recommended Dosage

Plaque Psoriasis and Psoriatic Arthritis:

Crohn’s Disease:

Ulcerative Colitis:

Dosage Forms & Strengths

Subcutaneous Injection

SKYRIZI Pen

  • Injection: 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled pen.

SKYRIZI Prefilled Syringe

  • Injection: 90 mg/mL as a colorless to slightly yellow and clear to slightly opalescent solution in each single-dose prefilled syringe.

  • Injection: 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled syringe.

  • Injection: 180 mg/1.2 mL (150 mg/mL) as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled syringe.

SKYRIZI Prefilled Cartridge with Supplied On-Body Injector

  • Injection: 180 mg/1.2 mL (150 mg/mL) as a colorless to yellow, and clear to slightly opalescent solution in each single-dose prefilled cartridge for use with the on-body injector.

  • Injection: 360 mg/2.4 mL (150 mg/mL) as a colorless to yellow, and clear to slightly opalescent solution in each single-dose prefilled cartridge for use with the on-body injector.

Intravenous
 
Infusion

 SKYRIZI Vial

  • Injection: 600 mg/10 mL (60 mg/mL) as a colorless to slightly yellow, and clear to slightly opalescent solution in each single-dose vial.
Pregnancy & Lactation

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with SKYRIZI. Patients should be encouraged to enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com.

Risk Summary

Available pharmacovigilance and clinical trial data with risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero

-
exposed infant
There are adverse pregnancy outcomes in women with inflammatory bowel disease
(see Clinical Considerations)
. 

In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition. Increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose

(see Data)
The 50 mg/kg dose in pregnant monkeys resulted in approximately 5 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 32 times the exposure (AUC) to the maximum recommended maintenance dose (360 mg). No risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age. The clinical significance of these findings for humans is unknown. 

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations 

Disease-associated maternal and embryo/fetal risk

Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth.

Fetal/Neonatal adverse reactions

Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Because risankizumab may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to SKYRIZI in utero. There are insufficient data regarding infant serum levels of risankizumab at birth and the duration of persistence of risankizumab in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 5 months after birth should be considered because of the half-life of the product.

Data

Animal Data

An enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition, and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study. There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology, or neurobehavioral development. However, a dose-dependent increase in fetal/infant loss was noted in the risankizumab-rzaa-treated groups (32% and 43% in the 5 mg/kg and 50 mg/kg groups, respectively) compared with the vehicle control group (19%). The increased fetal/infant loss in the 50 mg/kg group was considered to be related to risankizumab-rzaa treatment. The no-observed adverse effect level (NOAEL) for maternal toxicity was identified as 50 mg/kg, and the NOAEL for developmental toxicity was identified as 5 mg/kg. The 5 mg/kg dose in pregnant monkeys resulted in approximately 0.6 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 5 times the exposure (AUC) in humans administered the maximum recommended maintenance dose (360 mg).   In the infants, mean serum concentrations increased in a dose-dependent manner and were approximately 17%-86% of the respective maternal concentrations. Following delivery, most adult female cynomolgus monkeys and all infants from the risankizumab-rzaa-treated groups had measurable serum concentrations of risankizumab-rzaa up to 91 days postpartum. Serum concentrations were below detectable levels at 180 days postpartum.

Contraindications

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients

[see Warnings and Precautions (
)].

Warnings & Precautions
  • [Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur. 5.1]
    5.1 Hypersensitivity Reactions

    Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately

    [see Adverse Reactions (
    )].



  • [Infections: SKYRIZI may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer SKYRIZI until the infection resolves. 5.2]
    5.000000000000000e+00
    2
    Infections

    SKYRIZI may increase the risk of infections

    [see Adverse Reactions (
    )]

    Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

    In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer SKYRIZI until the infection resolves.



  • [Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI. 5.3]
    5.000000000000000e+00
    3
    Tuberculosis

    Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who were concurrently treated with SKYRIZI and appropriate TB prophylaxis during the studies, none developed active TB during the mean follow-up of 61 weeks on SKYRIZI. Two subjects taking isoniazid for treatment of latent TB discontinued treatment due to liver injury. Of the 31 subjects from the PsO-3 study with latent TB who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on SKYRIZI. Consider anti-TB therapy prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.



  • [Hepatotoxicity in Treatment of Inflammatory Bowel Disease: Drug-induced liver injury during induction has been reported. Monitor liver enzymes and bilirubin levels at baseline and, during induction, up to at least 12 weeks of treatment. Monitor thereafter according to routine patient management. 5.4]
    5.000000000000000e+00
    4
    Hepatotoxicity in Treatment of
    Inflammatory Bowel
    Disease

    A serious adverse reaction of drug-induced liver injury in conjunction with a rash that required hospitalization was reported in a patient with Crohn’s disease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two 600 mg intravenous doses of SKYRIZI. The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued.

    For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment. Monitor thereafter according to routine patient management.

    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. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.



  • [Administration of Vaccines: Avoid use of live vaccines. 5.5]
    5.5 Administration of Vaccines

    Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or inactive vaccines.

Adverse Reactions

The following adverse reactions are discussed in other sections of labeling:

  • Hypersensitivity Reactions
    [see Warnings and Precautions (
    )]


  • Infections
    [see Warnings and Precautions (
    )]


  • Tuberculosis
    [see Warnings and Precautions (
    )]


  • Hepatotoxicity in Treatment of Inflammatory Bowel Disease
    [see Warnings and Precautions (
    )]
Description

Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa.

SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use

Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2.

SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use
 

Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7.

SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use

Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76.0 mg), and Water for Injection, USP. The pH is 5.7.

SKYRIZI
(risankizumab-rzaa) injection
 
180
 
mg/
1.2
mL
(150 mg/
mL
)
prefilled
cartridge for use with supplied on-body-injector
for subcutaneous use

Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7.

SKYRIZI
(risankizumab-rzaa) injection
360 mg/2.4 mL (150 mg/mL) prefilled cartridge
 
for use with the supplied o
n-
b
ody
i
njector
for subcutaneous use
 

Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7.

SKYRIZI 600 mg/10 mL (60 mg/mL) in
a
vial for
intravenous
infusion

SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial.

Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.

Pharmacology

Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.

Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.

Nonclinical Toxicology

Carcinogenicity and mutagenicity studies have not been conducted with SKYRIZI.

No effects on male fertility parameters were observed in sexually mature male cynomolgus monkeys dosed weekly for 26 weeks with 50 mg/kg risankizumab-rzaa at 4 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 39 times the exposure in humans administered the maximum recommended maintenance dose (360 mg).

Clinical Studies
Figure 1. Percent of Subjects Achieving ACR20 Responses in Study PsA-1 through Week 24
How Supplied/Storage & Handling

How Supplied

SKYRIZI (risankizumab-rzaa) injection is supplied in the following strengths:

Strength
Pack Size
NDC
Subcutaneous Injection
150 mg/mL single-dose penCarton of 10074-2100-01
90 mg/mL single-dose prefilled syringeCarton of 20074-7040-02
Carton of 40074-7042-04
180 mg/1.2 mL (150 mg/mL) single-dose prefilled syringeCarton of 10074-8300-01
Carton of 20074-8350-01
150 mg/mL single-dose prefilled syringeCarton of 10074-1050-01
180 mg/1.2 mL (150 mg/mL) single-dose prefilled cartridge with on-body injectorKit0074-1065-01
360 mg/2.4 mL (150 mg/mL) single-dose prefilled cartridge with on-body injectorKit 0074-1070-01
Intravenous Infusion
600 mg/10 mL (60 mg/mL) single-dose vialCarton of 1 0074-5015-01

Subcutaneous Injection

SKYRIZI 150 mg/mL prefilled syringe or prefilled pen contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each prefilled syringe or prefilled pen consists of a 1 mL glass syringe with a fixed 27-gauge ½ inch needle with needle guard.

SKYRIZI 90 mg/mL prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow and clear to slightly opalescent solution. Each prefilled syringe consists of a 1 mL glass syringe with a fixed 29-gauge ½ inch needle with needle guard.

SKYRIZI 180 mg/1.2 mL (150 mg/mL) prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each prefilled syringe consists of a 2.25 mL glass syringe with a fixed 27-gauge ½ inch needle with needle guard.

SKYRIZI 180 mg/1.2 mL (150 mg/mL) cyclic olefin polymer prefilled cartridge with a septum and cap contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution for use with supplied on-body injector administration device.

SKYRIZI 360 mg/2.4 mL (150 mg/mL) cyclic olefin polymer prefilled cartridge with a septum and cap contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution for use with supplied on-body injector administration device.

Intravenous Infusion

SKYRIZI 600 mg/10 mL (60 mg/mL) vial contains a sterile and preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each glass vial is closed with a stopper and blue flip cap.

Storage and Handling

  • Store in a refrigerator at 36°F to 46° F (2°C to 8°C).

  • Do not freeze.

  • Do not shake.

  • Keep in the original cartons to protect from light.

  • Not made with natural rubber latex.
Instructions for Use

Instructions for Use


SKYRIZI
®
(sky-RIZZ-ee)
 
On-Body Injector


risankizumab-rzaa

injection, for subcutaneous use only

On-Body Injector and 180 mg/1.2 mL Prefilled Cartridge,

On-Body Injector and 360 mg/2.4 mL Prefilled Cartridge

Read this Instructions for Use before you start using SKYRIZI and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Refer to the Medication Guide for SKYRIZI product information. Call your healthcare provider, call (866) SKYRIZI or (866) 759-7494 or go to SKYRIZI.com

 
if you need help.

Important information you need to know before injecting SKYRIZI

  • Receive training on how to inject SKYRIZI before giving an injection.

  • Do not
    shake the SKYRIZI carton, On-Body Injector or prefilled cartridge.

  • Do not
    remove the On-Body Injector or prefilled cartridge from the carton until you are ready to inject.

  • Do not
    wait more than 5 minutes to start the injection after loading the cleaned prefilled cartridge into the On-Body Injector. Waiting will dry out the medicine and the On-Body Injector will not work afterwards.

  • Do not
    touch the start button until you place the On-Body Injector loaded with the prefilled cartridge onto your skin and are ready to inject.

    ◦ You can only press the start button 1-time.

  • Do not
    use On-Body Injector or prefilled cartridge if either has been dropped or damaged.

  • Do not
    reuse On-Body Injector or prefilled cartridge. The On-Body Injector and prefilled cartridge are for 1-time (single-dose) use only.

  • Do not
    let the On-Body Injector get wet with water or any other liquids.

  • This single-dose On-Body Injector is designed for use with SKYRIZI prefilled cartridge only.

  • Physical activity should be limited during the injection process. Moderate physical activities can be done, such as walking, reaching and bending.

  • Do not
    use SKYRIZI if the expiration date (EXP:) has passed.

  • Do not
    use the prefilled cartridge if the liquid is 
    discolored,
    cloudy
    or contains
    flakes
    or
    large
     
    particles
    The liquid should look clear to yellow and may contain tiny white or clear particles. 

  • The On-Body Injector and the prefilled cartridge are not made with natural rubber latex.

  • Keep SKYRIZI and all medicines out of the reach of children.

Storage and preparation for use

  • Keep SKYRIZI in the original carton to protect from light and physical damage until time to use.

  • Store SKYRIZI in your refrigerator between 36°F to 46°F (2°C to 8°C).

  • When ready to use, take the carton out of the refrigerator and leave it at room temperature for at least 45 minutes up to 90 minutes
     
    to allow SKYRIZI to warm.
    • The On-Body Injector will not work if left at
      room temperature
      for less than
      45 minutes.


  • Do not
    leave out in direct sunlight.

  • Do not
    remove the On-body Injector or prefilled cartridge from the carton while allowing SKYRIZI to reach room temperature.

  • Do not
    warm SKYRIZI in any other way. For example,
    do not
    warm it in a microwave or in hot water.

  • Do not
    use if liquid has been frozen (even if thawed).

  • Do not
    use SKYRIZI if carton perforations are broken. Return product to the pharmacy.
     


  • Do not
    use the On-Body Injector and prefilled cartridge if the white paper tray seal is missing or damaged and return the carton to the pharmacy.

Get to know your SKYRIZI On-Body Injector and prefilled cartridge

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Please read complete Instructions for Use before using SKYRIZI. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 or go to www.SKYRIZI.com if you need help or if you do not know how to proceed.

Step 1 Get ready
Before using SKYRIZI, you should receive training on how to inject SKYRIZI.
Referenced Image

Check expiration date
  • Remove the carton
     
    from the refrigerator.

  • Check expiration date (EXP:) on the carton.

  • Do not
    use SKYRIZI if the expiration date (EXP:)
     
    has passed.
Referenced Image
Wait at least 45 minutes
 

  • Leave unopened carton at room temperature to warm.

  • Keep out of direct sunlight.

  • Wait at least 45 minutes up to a maximum of 90 minutes
     
    to allow SKYRIZI to warm.
    • The On-Body Injector will not work if left at
      room temperature
      for less than
      45 minutes.


  • Do not
    warm SKYRIZI in any other way (for example,
    do not
    warm it in a microwave or in hot water).
Referenced Image
Open the carton and remove the plastic tray
 
  • Lift up
     
    the flap on the side of the carton.

  • Take out
     
    the plastic tray.
Referenced Image
Gather all supplies and wash hands
  • Place the following on a clean surface:

    ◦ plastic tray containing the On-Body Injector and prefilled cartridge (included)

    ◦ 2 alcohol wipes (not included)

    ◦ cotton ball or gauze pad (not included)

    ◦ sharps disposal container (not included) (see “Disposing of SKYRIZI”)

  • Wash and dry your hands.
Referenced Image

 

Remove the white paper tray seal
 
  • Locate
     
    the black arrow.

  • Peel away
     
    the white paper tray seal from the plastic tray.

  • Do not
    use the On-Body Injector and prefilled cartridge if the white paper tray seal is missing or damaged and return the carton to the pharmacy.
     
Referenced Image

Lift the plastic cover
 

  • Locate
     
    the
     
    rounded opening on the top cover.

  • Insert your pointer finger in the opening and place your thumb on the opposite side.

  • Lift the cover
     
    to remove and set aside.
Referenced Image
Inspect the On-Body Injector
 


  • Check
     
    that the On-Body Injector is intact and undamaged.

  • Do not
    close the gray door before the prefilled cartridge is loaded.

  • The gray door should be slightly open.

  • If the gray door does not open, press in firmly
     
    on the gray door ridges (left side of door) and swing open the door.

  • Do not
    use On-Body Injector if you drop it, discover missing pieces, or it is damaged.

  • Do not
    let the On-Body Injector get wet with water or any other liquids.
Referenced Image
 
Do not
touch the gray start button
 
until it is time to inject. It can be pressed 1-time
 
only.

If the gray start button is pressed before placing it on your body, the On-Body Injector can no longer be used. Call (866) SKYRIZI or (866) 759-7494.

  • Do not
    touch the needle cover or the needle.

  • Proceed to Set up On-Body Injector.
Step 2 Set up On-Body Injector
Referenced Image  
Fully open the gray door


Referenced Image
 
Avoid touching the needle cover or the needle
 
on the back of the On-Body Injector. The needle is behind the needle cover.
  • Swing the gray door
     
    all the way to the right to open it.

  • If the gray door does not open, press in firmly
     
    on the gray door ridges (left side of door) and swing open the door.

  • Do not
    close the gray door before the prefilled cartridge is loaded.

  • Do not
    touch the needle cover or needle.

  • Put the On-Body Injector aside.
Referenced Image
Inspect the prefilled cartridge
 

  • Carefully remove the prefilled cartridge from the plastic tray.

  • Do not
    twist or remove cartridge top.

  • Check the prefilled cartridge to make sure:

    ◦ The expiration date
     
    (EXP:)
     
    has not passed.

    ◦ The liquid should look clear to yellow and may contain tiny white or clear particles. It is normal to see one or more bubbles.

    ◦ The prefilled cartridge parts appear intact, and the clear plastic is not cracked or broken.

  • Do not
    use if the expiration date
     
    (EXP:)
     
    has passed.

  • Do not
    use if the liquid is cloudy, discolored, or contains flakes or large particles.

  • Do not
    use if the liquid has been frozen
     
    (even if thawed).

  • Do not
    use the prefilled cartridge if you drop it, discover missing pieces, or it is damaged.
Referenced Image
Clean the smaller bottom tip of the prefilled cartridge


  • Locate
     
    the smaller bottom tip of the prefilled cartridge.

  • Clean the smaller bottom tip of the prefilled cartridge with an alcohol wipe. Make sure to use the alcohol wipe to clean the center of the smaller bottom tip
     
    of the prefilled cartridge.

  • Do not
    touch the smaller bottom tip of the prefilled cartridge after cleaning.
Referenced Image 



Load the cleaned prefilled cartridge into the On-Body Injector
 

  • Do not
    twist or remove the prefilled cartridge top.

  • Insert the
     
    smaller bottom tip of the prefilled cartridge into the On-Body Injector first.

  • Firmly push down on the prefilled cartridge top until you hear a “click”. 

  • After loading the prefilled cartridge, you may see a few drops of medicine on the back of the On-Body Injector. This is normal.
Referenced Image
Make sure that you start the injection within 5 minutes after inserting the prefilled cartridge into the On-Body Injector. Waiting will dry out the medicine and the On-Body Injector will not work afterwards.
Referenced Image 

Close the gray door


  • Swing the gray door to the left, then squeeze firmly
     
    and listen for the gray door to "snap" shut.

  • The gray door should stay locked after loading the prefilled cartridge.

  • Do not
    close the gray door if the prefilled cartridge is not fully inserted or is missing.

  • Proceed without delay to Prepare to inject
Step 3 Prepare to inject
Keep electronic devices including cell phones at least 12 inches (30 cm) from On-Body Injector until injection is complete
Referenced Image
Pick your injection area
 

Locate a firm and flat area
 
on your bare skin. Make sure the area is clear of clothing:
  • Your abdomen
     
    (belly) at least 2 inches from your navel (belly button).

  • The front of your left thigh or your right thigh.

  • Do not
    inject into areas of the skin
     
    that naturally fold or bulge
     
    because the On-Body Injector could fall off during wear.

  • Do not
    inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, moles or excessive hair. You can trim the excessive hair from the injection area.
Referenced Image
Clean the injection area
 

  • Clean
     
    injection area with an alcohol wipe.

  • Allow the injection area to completely dry.

  • Do not
    touch cleaned injection area before placing the On-Body Injector on the skin.
Referenced Image  
Peel both tabs to expose adhesive
 

  • Turn the On-Body Injector over
     
    to find both green pull tabs.
Referenced Image
 
Avoid touching the needle cover (needle inside).

  • Peel
     
    away the large section
     
    using the green pull tab to expose the adhesive.

  • Peel
     
    away the small section
     
    using the green pull tab to expose the adhesive. This will remove the clear plastic strip, activating the On-Body Injector.

  • Do not
    pull the adhesive material off the On-Body Injector or allow the sticky side to fold and stick to itself.

  • Check the status light
     
    when the On-Body Injector beeps.

  • The status light will flash blue
     
    when the On-Body Injector is activated.

  • If the status light does not flash blue, call (866) SKYRIZI or (866) 759-7494.

  • Do not
    press the gray start button yet.

  • Do not
    touch the needle cover or the needle.
  

Referenced Image
Referenced Image

Prepare the On-Body Injector for placement
 
  • For the abdomen
     
    (belly), move and hold the skin to create a firm, flat surface for injection at least 2 inches from your navel
     
    (belly button). Make sure to adjust your posture (sit up straight) to avoid skin folds and bulges.

  • You do not need to pull the skin flat for the front of left thigh or right thigh.

  • Make sure to position the On-Body Injector so that you can see the blue status light.
Referenced Image
Place the On-Body Injector on your skin
 

  • When the blue light flashes, the On-Body Injector is ready. Place
     
    the On-Body Injector onto the cleaned skin with the status light visible.

  • Do not
    place the On-Body Injector on clothes. Only place on bare skin.

  • Run your finger around the adhesive material to secure it. Make sure all of the adhesive is attached to your skin.

  • Do not
    move or adjust the On-Body Injector after it has been placed on your skin.

  • When the On-Body Injector is on your skin, proceed to Inject medicine
Step 4 Inject medicine
Referenced Image 
Start injection
 

  • Firmly press
     
    the gray start button until you hear a click. Then release the gray start button.

  • Do not
    touch the gray start button until you place the On-Body Injector loaded with the prefilled cartridge onto your skin and are ready to inject. You can only press the start button 1 time.

  • You may feel a needle pinch.

  • Check the status light
     
    when the On-Body Injector beeps.

  • After starting the injection, the status light will continuously flash green.

  • You will hear pumping
     
    sounds as the On-Body Injector delivers the medicine.

  • Do not
    continue to use the On-Body Injector if status light flashes red and beeps. Carefully remove from skin if the status light flashes red. Call (866) SKYRIZI or (866) 759-7494.
Referenced Image

 
Wait for the injection to finish


  • It may take up to 5 minutes
     
    to complete full dose of medicine. The On-Body Injector will automatically stop when the injection is finished.
During the injection:

◦ the status light will continue to flash green.

◦ you will hear pumping
 
sounds as the On-Body Injector continues delivering the medicine.

◦ moderate physical activities can be done, such as walking, reaching and bending.

  • Do not
    continue to use the On-Body Injector if the status light flashes red and beeps. Carefully remove it from the skin if the status light flashes red and beeps. Call (866) SKYRIZI or (866) 759-7494.
Referenced Image
Injection is finished


  • The On-Body Injector will stop on its own.

  • After the injection is finished, you will hear beeps and the status light will change to solid green. Check the status light. If it has changed to solid green, this means that the injection is finished.

  • When the injection is finished, proceed to next step.
Referenced Image





























Remove the On-Body Injector
 

  • Do not
     
    put your fingers on the back side of the On-Body Injector when removing it from your skin.

  • When the injection is done, grab the corner of the adhesive to carefully peel the On-Body Injector from the skin.
Referenced Image Avoid touching the needle cover
 
or needle
 
on the back of the On-Body Injector.
  • After removing the On-Body Injector, you will hear several beeps
     
    and the status light will turn off.

  • The needle cover will cover the needle when the On-Body Injector is removed from the skin.

  • It is normal to see a few small drops of liquid on your skin after removing the On-Body Injector. If you see more than a few small drops of liquid left on your skin, call (866) SKYRIZI or (866) 759-7494.

  • Press a cotton ball or gauze pad over the injection site on your skin and hold for 10 seconds.

  • Do not
    rub the injection site.

  • Slight bleeding at the injection site is normal.

  • Proceed to Confirm and dispose
Step 5 Confirm and dispose
Referenced Image

Check the On-Body Injector


  • Inspect the medicine window and status light.

  • Check to see that the used white plunger fills the medicine window and the solid green light turns off, letting you know that all the medicine has been injected.
Referenced Image If the used white plunger does not fill the window, call (866) SKYRIZI or (866) 759-7494
Referenced Image 

Put the used On-Body Injector in an FDA-cleared sharps disposal container right away after use


  • Leave the prefilled cartridge in the On-Body Injector.

  • Do not
    throw away (dispose of) the used On-Body Injector in your household trash.

  • For more information, see “
    Disposing of SKYRIZI”
    section.

Referenced Image

Please read complete Instructions for Use before using SKYRIZI. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 or go to www.SKYRIZI.com if you need help or if you do not know how to proceed.

Commonly asked questions
 

Q.
 
What if I cannot open the On-Body Injector door to insert the prefilled cartridge?

A.
  To open the On-Body Injector door, press in firmly on the left side of the door to release the door latch. If you are still unable to open the door, call (866) SKYRIZI or (866) 759-7494.

Q.
 
What if I push the
gray
start button before I place the On-Body Injector on my skin?

A.
The gray start button may be pressed just 1 time only. If the gray start button is pressed before placing it on your body, it can no longer be used. Call (866) SKYRIZI or (866) 759-7494.

Q.
What if the On-Body Injector does not beep and the blue status light does not flash when I remove the green pull tabs?

A.
Peeling off small green pull tab will remove the clear plastic strip, activating the On-Body Injector. If all of the adhesive paper has been removed and the On-Body Injector still does not turn on, call (866) SKYRIZI or (866) 759-7494.

Q.
What if I push the start button as instructed after placing the On-Body Injector on the skin and the light remains blue?

A.
  Firmly press the gray start button again. If the status light remains blue or flashes red, remove the On-Body Injector by carefully peeling it away from your skin. Do not re-apply the On-Body Injector. Call (866) SKYRIZI or (866) 759-7494.

Q.
 
 
What if the status light flashes red and beeps while wearing the On-Body Injector?

A.
  If the status light continuously flashes red and beeps, do not use the On-Body Injector. If it is attached to your body, carefully remove it. Call (866) SKYRIZI or (866) 759-7494.

Q.
 
 
What should I do if the On-Body Injector comes off my body during the injection?

A.
  The loaded On-Body Injector can no longer be used. Do not re-apply it to your body. Call (866) SKYRIZI or (866) 759-7494.

Q.
 
 
How do I know when the injection is complete?

A.
  The injection is complete when the On-Body Injector beeps, the white plunger has completely filled the medicine window, and the status light turns from flashing green to solid green.

Q.
  
What should I do if there are more than a few drops of liquid on the injection area?

A.
  Call (866) SKYRIZI or (866) 759-7494
 
for help.

Q.
What should I do with the used On-Body Injector after my injection?

A.
  Throw away (dispose of) used On-Body Injector in a FDA-cleared sharps disposal container and not your household trash. You can receive a sharps container for SKYRIZI disposal at no additional cost by going to www.SKYRIZI.com or by calling (866) SKYRIZI or (866) 759-7494.

Q.
 
 
What if I have not received in-person training from a healthcare professional?

A.
  Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help.

Receive
training on how to inject
SKYRIZI
before giving injections.

Referenced Image

Disposing of SKYRIZI

  • Put SKYRIZI in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) SKYRIZI in your household trash.

  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

    ◦ made of a heavy-duty plastic,

    ◦ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

    ◦ upright and stable during use,

    ◦ leak-resistant, and

    ◦ properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.

Do not
recycle your used sharps disposal container.

Additional information

● Type BF applied part.

● Referenced Image On-Body Injector sterilized using ethylene oxide.

● Altitude range is -1,312 feet to 10,499 feet (-400 meters to 3,200 meters).

Electromagnetic Compatibility (EMC) of the On-Body Injector

The On-Body Injector is intended for home use or use in a professional healthcare environment and complies with ISO 11608-1:2014 and IEC 60601-1-2:2014.

Care should be taken to use the On-Body Injector within the following specific limits and environments to avoid adversely impacting the performance (missed or incomplete SKYRIZI dose).

  • Keep electronic devices including cell phones at least 12 inches (30 cm) from the On-Body Injector until injection is complete. The potential impact of electronic interference is unknown when the On-Body Injector is operated within 12 inches (30 cm).

  • Do not expose the On-Body Injector to Magnetic Resonance (MR) Environment (e.g., MRI).

  • If it is used adjacent to other electrical equipment, observe the On-Body Injector and other equipment to ensure it is operating normally.

Emissions

Emissions test nameTest levels
Radiated Radio frequency electromagnetic fieldsPer CISPR 11, class B

Electromagnetic Immunity

Test Name Test Levels
Electrostatic discharge (ESD)± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radio frequency electromagnetic field10 V/m

80 MHz – 2.7 GHz
Power frequency 50 Hz magnetic field 30 A/m

The enclosure port immunity to RF wireless communications equipment complies with IEC 60601-1-2:2014. 

  

Glossary of symbols

Symbol
Description of Symbol
Referenced ImageKeep dry
Referenced ImageSterilized using ethylene oxide
Referenced ImageDo not re-use
Referenced ImageDo not use if package is damaged and consult instructions for use
Referenced ImageDate of manufacture
Referenced ImageBatch code
Referenced ImageCatalogue number
Referenced ImageSerial number
Referenced ImageRefer to instruction manual / booklet
Referenced ImageType BF Applied Part
Referenced ImageMR Unsafe

Manufactured by:

AbbVie Inc., North Chicago, IL 60064, U.S.A.

US License Number 1889

SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.

©2024 AbbVie Inc.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 6/2024

20086115

Mechanism of Action

Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.

Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available

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