HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SKYRIZI safely and effectively. See full prescribing information for
SKYRIZI.
SKYRIZI® (risankizumab-rzaa) injection, for subcutaneous or
intravenous use
Initial U.S. Approval: 2019
RECENT MAJOR CHANGES
Indications and Usage, Crohn’s Disease (1.3)
Indications and Usage, Psoriatic Arthritis (1.2)
Dosage and Administration (2.1, 2.2, 2.6, 2.7)
Dosage and Administration, Psoriatic Arthritis (2.4)
Warnings and Precautions, Hypersensitivity Reactions (5.1)
Warnings and Precautions, Hepatotoxicity in Treatment of
Crohn’s Disease (5.4)

06/2022
01/2022
06/2022
01/2022
01/2022
06/2022

INDICATIONS AND 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)• active psoriatic arthritis in adults. (1.2)• moderately to severely active Crohn's disease in adults. (1.3)
DOSAGE AND ADMINISTRATION
Recommended Dosage
Plaque Psoriasis and Psoriatic Arthritis:• 150 mg administered by subcutaneous injection at Week 0, Week 4, andevery 12 weeks thereafter. (2.3, 2.4)
• In patients with psoriatic arthritis SKYRIZI can be administered alone or in
combination with non-biologic disease-modifying antirheumatic drugs(DMARDs). (2.4)
Crohn’s Disease:• Obtain liver enzymes and bilirubin levels prior to initiating treatment withSKYRIZI. (2.1, 5.4)
• The recommended induction dosage is 600 mg administered by intravenous
infusion over at least one hour at Week 0, Week 4, and Week 8. The
recommended maintenance dosage is 360 mg administered by
subcutaneous injection at Week 12, and every 8 weeks thereafter. (2.6)• Injection: 150 mg/mL in each single-dose prefilled syringe. (3)• Injection: 75 mg/0.83 mL in each single-dose prefilled syringe. (3)• Injection: 360 mg/2.4 mL (150 mg/mL) in each single-dose prefilled
cartridge. (3)Intravenous infusion (3)• Injection: 600 mg/10 mL (60 mg/mL) in each single-dose vial. (3)CONTRAINDICATIONS• SKYRIZI is contraindicated in patients with a history of serious
hypersensitivity reaction to risankizumab-rzaa or any of the excipients (4)WARNINGS AND PRECAUTIONS• Hypersensitivity Reactions: Serious hypersensitivity reactions, including
anaphylaxis, may occur (5.1)• Infections: SKYRIZI may increase the risk of infection. Instruct patients toseek medical advice if signs or symptoms of clinically important infection
occur. If such an infection develops, do not administer SKYRIZI until theinfection resolves. (5.2)• Tuberculosis (TB): Evaluate for TB prior to initiating treatment withSKYRIZI. (5.3)• Hepatotoxicity in Treatment of Crohn’s Disease: Drug-induced liver injury
during induction has been reported. Monitor liver enzymes and bilirubinlevels at baseline and, during induction, up to at least 12 weeks oftreatment. Monitor thereafter according to routine patient management.
(5.4)• Administration of Vaccines: Avoid use of live vaccines. (5.5)
ADVERSE REACTIONS
Most common adverse reactions are:
• Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory
infections, headache, fatigue, injection site reactions, and tinea infections.
(6.1)• Crohn’s Disease (>3%):o Induction: upper respiratory infections, headache, and arthralgia. (6.1)
o Maintenance: arthralgia, injection site reactions, abdominal pain,
anemia, pyrexia, back pain, arthropathy, and urinary tract infection.
(6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc.
at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.

DOSAGE FORMS AND STRENGTHS
Subcutaneous injection (3)• Injection: 150 mg/mL in each single-dose prefilled pen. (3)Revised: 06/2022

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Plaque Psoriasis
1.2 Psoriatic Arthritis
1.3 Crohn’s Disease
2 DOSAGE AND ADMINISTRATION
2.1 Procedures Prior to Treatment Initiation
2.2 General Considerations for Administration
2.3 Plaque Psoriasis
2.4 Psoriatic Arthritis
2.5 Preparation and Administration Instruction (Plaque Psoriasis andPsoriatic Arthritis)
2.6 Crohn’s Disease
2.7 Preparation and Administration Instructions (Crohn’s Disease)
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Infections
5.3 Tuberculosis
5.4 Hepatotoxicity in Treatment of Crohn’s Disease
5.5 Administration of Vaccines
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience

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6.2 Immunogenicity
6.3 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Plaque Psoriasis
14.2 Psoriatic Arthritis
14.3 Crohn’s Disease
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are notlisted.

FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Plaque Psoriasis
SKYRIZI® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults whoare candidates for systemic therapy or phototherapy.
1.2 Psoriatic Arthritis
SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
1.3 Crohn’s Disease
SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in
adults.
2 DOSAGE AND ADMINISTRATION
2.1 Procedures Prior to Treatment Initiation

For the treatment of Crohn’s disease, obtain liver enzymes and bilirubin levels prior toinitiating treatment with SKYRIZI [see Warnings and Precautions (5.4)]



Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI[see Warnings and Precautions (5.3)].

Complete all age-appropriate vaccinations as recommended by current immunization
guidelines [see Warnings and Precautions (5.5)].

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.
o SKYRIZI 150 mg/mL and 360 mg/2.4 mL: a colorless to yellow, and clear toslightly opalescent solution.
o SKYRIZI 75 mg/0.83 mL and 600 mg/10 mL: a colorless to slightly yellow, andclear to slightly opalescent solution.

o Do not use if the solution contains large particles or is cloudy or discolored.
Discard after use. Do not reuse.

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2.3 Recommended Dosage for Plaque Psoriasis
The recommended dosage is 150 mg administered by subcutaneous injection at Week 0, Week 4,
and every 12 weeks thereafter.
2.4 Recommended Dosage for Psoriatic Arthritis
The recommended dosage is 150 mg administered by subcutaneous injection at Week 0, Week 4,
and every 12 weeks thereafter.
SKYRIZI may be administered alone or in combination with non-biologic disease-modifying
antirheumatic drugs (DMARDs).
2.5 Preparation and Administration Instruction (Plaque Psoriasis and Psoriatic Arthritis)

Administer SKYRIZI prefilled pen or prefilled syringe(s) 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 with SKYRIZI from the refrigerator and without
removing the prefilled pen or prefilled syringe(s) from the carton, allow SKYRIZI toreach room temperature out of direct sunlight (30 to 90 minutes for the prefilled pen and
15 to 30 minutes for the prefilled syringe(s)).

When using SKYRIZI 150 mg/mL prefilled pen or prefilled syringe, inject one 150 mg
single-dose prefilled pen or prefilled syringe.

When using SKYRIZI 75 mg/0.83 mL prefilled syringes, for a 150 mg dose, two 75 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 oraffected by psoriasis. 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 Instructions for Use]. Instruct thepatient to read the Instructions for Use before administration.

2.6 Recommended Dosage for Crohn’s Disease
Adult Patients: Induction
The recommended induction dosage of SKYRIZI is 600 mg administered by intravenous
infusion over a period of at least one hour at Week 0, Week 4, and Week 8.

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Adult Patients: Maintenance
The recommended maintenance dosage of SKYRIZI is 360 mg administered by subcutaneous
injection at Week 12, and every 8 weeks thereafter.
2.7 Preparation and Administration Instructions (Crohn’s Disease)
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, withdraw 10 mL of SKYRIZI solution from the vial andinject into an intravenous infusion bag or glass bottle containing 5% Dextrose Injection (600
mg/10 mL in 100 mL, or 250 mL, or 500 mL) for a final concentration of approximately 1.2
mg/mL to 6 mg/mL. Discard any remaining solution in the vial.
3. Do not shake the vial or diluted solution in the infusion bag or glass bottle.
4. Allow the diluted SKYRIZI solution in the infusion bag or glass bottle to warm to room
temperature (if stored refrigerated) prior to the start of the intravenous infusion.
5. Infuse the diluted solution intravenously over a period of at least one hour. Complete theinfusion within 8 hours of dilution.
6. Do not administer SKYRIZI diluted solution concomitantly in the same intravenous line withother medicinal products.
Storage of Diluted Solution:
If not used immediately, store the diluted SKYRIZI solution refrigerated and protected from lightfor up to 20 hours between 36°F to 46°F (2°C to 8°C). Subsequently, the diluted SKYRIZI
solution can be stored (protected from direct and indirect sunlight) for 8 hours at room
temperature at up to 77°F (25°C) after dilution (cumulative time after preparation including thestorage and the infusion period). Do not freeze.
Subcutaneous Maintenance Dosing Regimen:

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 therefrigerator 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 360 mg/2.4 mL prefilled cartridge
subcutaneously on thigh or abdomen.

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

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



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

The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation andadministration of SKYRIZI [see Instructions for Use]. Instruct the patient to read theInstructions for Use before administration.
3 DOSAGE FORMS AND STRENGTHS
Subcutaneous Injection
SKYRIZI Pen

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

SKYRIZI Prefilled SyringeInjection: 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution ineach single-dose prefilled syringe.



Injection: 75 mg/0.83 mL as a colorless to slightly yellow and clear to slightly opalescentsolution in each single-dose prefilled syringe.

SKYRIZI Prefilled Cartridge with Supplied 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 toslightly opalescent solution in each single-dose vial.

4 CONTRAINDICATIONSSKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction torisankizumab-rzaa or any of the excipients [see Warnings and Precautions (5.1)].

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5 WARNINGS AND PRECAUTIONS
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 (6.1)].
5.2 Infections
SKYRIZI may increase the risk of infections [see Adverse Reactions (6.1)].
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 andbenefits 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.
5.3 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 wereconcurrently 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 symptomsof active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients withactive TB.
5.4 Hepatotoxicity in Treatment of Crohn’s Disease
A serious adverse reaction of drug-induced liver injury was reported in a patient with Crohn’sdisease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two
intravenous doses of SKYRIZI 600 mg in conjunction with a rash that required hospitalization.
The liver test abnormalities resolved following administration of steroids. SKYRIZI was
subsequently discontinued.
For the treatment of Crohn’s disease, evaluate liver enzymes and bilirubin at baseline, and during
induction at least up to 12 weeks of treatment. Monitor thereafter according to routine patientmanagement.
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 casesof drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until

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this diagnosis is excluded. Instruct patients to seek immediate medical attention if theyexperience symptoms suggestive of hepatic dysfunction.
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 tocurrent immunization guidelines. No data are available on the response to live or inactive
vaccines.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of labeling:• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]• Infections [see Warnings and Precautions (5.2)]• Tuberculosis [see Warnings and Precautions (5.3)]• Hepatotoxicity in Treatment of Crohn’s disease [see Warnings and Precautions (5.4)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse drug reaction
rates observed in the clinical trials of a drug cannot be directly compared with rates in theclinical trials of another drug and may not reflect the rates observed in practice.
Plaque Psoriasis
A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaquepsoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.
Data from placebo- and active-controlled trials were pooled to evaluate the safety of SKYRIZI
for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group.
Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% and at ahigher rate in the SKYRIZI group than the placebo group during the 16-week controlled periodof pooled clinical trials.
Table 1. Adverse Drug Reactions Occurring in ≥ 1% of Subjects on SKYRIZI throughWeek 16
SKYRIZI
Placebo
Adverse Drug Reactions
N = 1306
N = 300
n (%)
n (%)
a
Upper respiratory infections
170 (13.0)
29 (9.7)b
Headache46 (3.5)
6 (2.0)c
Fatigue
33 (2.5)
3 (1.0)d
Injection site reactions
19 (1.5)
3 (1.0)

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Adverse Drug Reactions
Tinea infectionse

SKYRIZI
N = 1306n (%)
15 (1.1)

Placebo
N = 300n (%)
1 (0.3)aIncludes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis,
nasopharyngitis, pharyngitis (including viral), tonsillitisbIncludes: headache, tension headache, sinus headache, cervicogenic headachecIncludes: fatigue, astheniadIncludes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation,
irritation, pain, pruritus, reaction, swelling, warmtheIncludes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis

Adverse drug reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group andat a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.
Specific Adverse Drug Reactions
Infections
In the first 16 weeks, infections occurred in 22.1% of the SKYRIZI group (90.8 events per 100
subject-years) compared with 14.7% of the placebo group (56.5 events per 100 subject-years)
and did not lead to discontinuation of SKYRIZI. The rates of serious infections for the SKYRIZI
group and the placebo group were ≤0.4%. Serious infections in the SKYRIZI group included
cellulitis, osteomyelitis, sepsis, and herpes zoster. In Studies PsO-1 and PsO-2, through Week
52, the rate of infections (73.9 events per 100 subject-years) was similar to the rate observed
during the first 16 weeks of treatment.
Safety Through Week 52
Through Week 52, no new adverse reactions were identified, and the rates of the adverse
reactions were similar to those observed during the first 16 weeks of treatment. During thisperiod, serious infections that led to study discontinuation included pneumonia.
Psoriatic Arthritis
The overall safety profile observed in subjects with psoriatic arthritis treated with SKYRIZI isgenerally consistent with the safety profile in subjects with plaque psoriasis. Additionally, in the
Phase 3 placebo-controlled trials the incidence of hepatic events was higher in the SKYRIZI
group (5.4%, 16.7 events per 100 patient years) compared to the placebo group (3.9%, 12.6
events per 100 patient years). Of these, the most common events that were reported more
frequently in both the placebo group and the SKYRIZI group were ALT increased (placebo:
n=12 (1.7%); SKYRIZI: n=16 (2.3%)), AST increased (placebo: n=9 (1.3%); SKYRIZI: n=13
(1.8%)), and GGT increased (placebo: n=5 (0.7%); SKYRIZI: n=8 (1.1%)). There were noserious hepatic events reported. The incidence of hypersensitivity reactions was higher in the
SKYRIZI group (n=16, 2.3%) compared to the placebo group (n=9, 1.3%). In the Phase 3
placebo-controlled trials, hypersensitivity reactions reported at a higher rate in the SKYRIZI
group included rash (placebo: n=4 (0.6%); SKYRIZI: n=5 (0.7%), allergic rhinitis (placebo: n=1(0.1%); SKYRIZI: n=2 (0.3%), and facial swelling (placebo: n=0 (0.0%); SKYRIZI n=1 (0.1%).
One case of anaphylaxis was reported in a subject who received SKYRIZI in the Phase 2 clinical
trial.

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Crohn’s Disease
SKYRIZI was studied up to 12 weeks in subjects with moderately to severely active Crohn’sdisease in two randomized, double-blind, placebo-controlled induction studies (CD-1, CD-2) anda randomized, double-blind, placebo-controlled, dose-finding study (CD-4; NCT02031276).
Long-term safety up to 52 weeks was evaluated in subjects who responded to induction therapy
in a randomized, double-blind, placebo-controlled maintenance study (CD-3) [see ClinicalStudies (14.3)].
In the two induction studies (CD-1, CD-2) and the dose finding study (CD-4), 620 subjects
received the SKYRIZI intravenous induction regimen. In the maintenance study (CD-3), 142
subjects who achieved clinical response defined as a reduction in CDAI of at least 100 points
from baseline after 12 weeks of induction treatment with intravenous SKYRIZI in studies CD-1
and CD-2, received SKYRIZI subcutaneously as a maintenance regimen.
Adverse reactions reported in > 3% of subjects in induction studies and at a higher rate thanplacebo are shown in Table 2.
Table 2. Adverse Drug Reactions Reported in > 3% of Subjects with Crohn’s Disease
Treated with SKYRIZI in Placebo-Controlled 12-Week Induction Studies
SKYRIZI
600 mg Intravenous
PlaceboaAdverse Drug Reactions
Infusion
N = 432
N = 620
n (%)
n (%)
b
Upper respiratory infections
66 (10.6)
40 (9.3)c
Headache41 (6.6)
24 (5.6)
Arthralgia
31 (5.0)
19 (4.4)
a

SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8.
Includes: influenza like illness, nasopharyngitis, influenza, pharyngitis, upper respiratory tract infection, viral
upper respiratory tract infection, COVID-19, nasal congestion, respiratory tract infection viral, viral pharyngitis,
tonsillitis, upper respiratory tract inflammationcIncludes: headache, tension headachebAdverse reactions reported in >3% of subjects in the maintenance study and at a higher rate thanplacebo are shown in Table 3.
Table 3. Adverse Reactions Reported in >3% of Subjects with Crohn’s Disease Treatedwith SKYRIZI in Placebo-Controlled 52-Week Maintenance Study (CD-3)
SKYRIZI
360 mg Subcutaneous
Placebo
Adverse Drug Reactions
Injectiona
N = 143
N = 142n (%)
n (%)
Arthralgia
13 (9.2)
12 (8.4)b,cInjection site reactions
8 (5.6)4 (2.8)dAbdominal pain
12 (8.5)
6 (4.2)
Anemia7 (4.9)6 (4.2)

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Adverse Drug Reactions

Pyrexia
Back pain
Arthropathy
Urinary tract infection

SKYRIZI
360 mg Subcutaneous
Injectiona
N = 142n (%)
7 (4.9)6 (4.2)5 (3.5)5 (3.5)

Placebo
N = 143n (%)
4 (2.8)3 (2.1)2 (1.4)4 (2.8)a

SKYRIZI 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks
Includes: injection site rash, injection site erythema, injection site swelling, injection site urticaria, injection site
warmth, injection site pain, injection site hypersensitivity, injection site reactioncSome subjects had multiple occurrences of injection site reactions. The adverse reaction is included only once per
subject.
dIncludes: abdominal pain, abdominal pain upper, abdominal pain lowerbSpecific Adverse Drug Reactions
Infections
In the maintenance study (CD-3) through Week 52, the rate of infections was 36.6% (60.8 events
per 100 subject-years) in subjects who received SKYRIZI compared to 36.4% (60.3 events per
100 subject-years) in subjects who received placebo after SKYRIZI induction. The rate ofserious infections was 5.6% (7.4 events per 100 subject-years) in subjects who received
SKYRIZI compared to 2.1% (2.4 events per 100 subject-years) in subjects who received placebo
after SKYRIZI induction.
Lipid Elevations
Elevations in lipid parameters (total cholesterol and low-density lipoprotein cholesterol [LDLC]) were first assessed at 4 weeks following initiation of SKYRIZI in the induction trials (CD-1,
CD-2). Increases from baseline and increases relative to placebo were observed at Week 4 andremained stable to Week 12. Following SKYRIZI induction, mean total cholesterol increased by
9.4 mg/dL from baseline to a mean absolute value of 175.1 mg/dL at Week 12. Similarly, mean
LDL-C increased by 6.6 mg/dL from baseline to a mean absolute value of 92.6 mg/dL Week 12.
Following maintenance treatment with SKYRIZI, mean LDL-C increased by 2.3 mg/dL frombaseline to Week 52, to an absolute value of 102.2 mg/dL.
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody
formation is highly dependent on the sensitivity and specificity of the assay. Additionally, theobserved incidence of antibody (including neutralizing antibody) positivity in an assay may be
influenced by several factors including assay methodology, sample handling, timing of sample
collection, concomitant medications, and underlying disease. For these reasons, comparison of
the incidence of antibodies in the studies described below with the incidence of antibodies inother studies or to other products, including other risankizumab products, may be misleading.

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Plaque Psoriasis
By Week 52, approximately 24% (263/1079) of subjects treated with SKYRIZI at therecommended dose developed antibodies to risankizumab-rzaa. Of the subjects who developed
antibodies to risankizumab-rzaa, approximately 57% (14% of all subjects treated with SKYRIZI)
had antibodies that were classified as neutralizing. Higher antibody titers in approximately 1% ofsubjects treated with SKYRIZI were associated with lower risankizumab-rzaa concentrations andreduced clinical response.
Psoriatic Arthritis
By Week 28, approximately 12.1% (79/652) of subjects treated with SKYRIZI at therecommended dose developed antibodies to risankizumab-rzaa. None of the subjects whodeveloped antibodies to risankizumab-rzaa had antibodies that were classified as neutralizing.
Antibodies to risankizumab-rzaa were not associated with changes in clinical response forpsoriatic arthritis. A higher proportion of subjects with anti-drug antibodies experienced
hypersensitivity reactions (6.3% (5/79)) and injection site reactions (2.5% (2/79)) compared tosubjects without anti-drug antibodies (3.8% (22/574) with hypersensitivity reactions and 0.7%
(4/574) with injection site reactions). None of these hypersensitivity and injection site reactions
led to discontinuation of risankizumab-rzaa.
Crohn’s Disease
By Week 64, approximately 3.4% (2/58) of subjects treated with SKYRIZI at the recommended
induction and maintenance dosages developed antibodies to risankizumab-rzaa. None of thesubjects who developed antibodies to risankizumab-rzaa had antibodies that were classified as
neutralizing.
6.3 Postmarketing Experience
The following adverse reactions have been reported during post-approval of SKYRIZI. Because
these reactions are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal relationship to SKYRIZI
exposure:

Skin and subcutaneous tissue disorders: eczema and rash

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
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 orvisiting 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

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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 inwomen 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 inapproximately 10 times the exposure (AUC) in humans administered the 600 mg induction
regimen and 39 times the exposure (AUC) to the 360 mg maintenance doses, respectively. No
risankizumab-rzaa-related effects on functional or immunological development were observed ininfant 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 andmiscarriage 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 2500 g) infants, andsmall 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 toinfants 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 ofrisankizumab-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, aReference ID: 5000374

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 berelated 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. On an exposure (AUC) basis, the 5 mg/kg dose in pregnant monkeys
resulted in approximately 1.24 times the exposure in humans administered the 600 mg induction
regimen and 5 times the exposure in humans administered the 360 mg maintenance doses,
respectively. 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-treatedgroups had measurable serum concentrations of risankizumab-rzaa up to 91 days postpartum.
Serum concentrations were below detectable levels at 180 days postpartum.
8.2 Lactation
Risk Summary
There are no data on the presence of risankizumab-rzaa in human milk, the effects on thebreastfed infant, or the effects on milk production. Endogenous maternal IgG and monoclonal
antibodies are transferred in human milk. The effects of local gastrointestinal exposure andlimited systemic exposure in the breastfed infant to risankizumab-rzaa are unknown. The
developmental and health benefits of breastfeeding should be considered along with the mother'sclinical need for SKYRIZI and any potential adverse effects on the breastfed infant fromSKYRIZI or from the underlying maternal condition.
8.4 Pediatric Use
The safety and effectiveness of SKYRIZI have not been established in pediatric patients.
8.5 Geriatric Use
Of the 2234 subjects with plaque psoriasis exposed to SKYRIZI, 243 subjects were 65 years orolder and 24 subjects were 75 years or older. No overall differences in SKYRIZI exposure,safety, or effectiveness were observed between older and younger subjects who received
SKYRIZI. However, the number of subjects aged 65 years and older was not sufficient todetermine whether they respond differently from younger subjects.
Clinical studies of SKYRIZI for the treatment of Crohn’s disease did not include sufficientnumbers of subjects 65 years of age and older to determine whether they respond differently
from younger adult subjects.
No clinically meaningful differences in the pharmacokinetics of risankizumab-rzaa wereobserved in geriatric subjects compared to younger adult subjects with Crohn’s disease [seeClinical Pharmacology (12.3)].

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11 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 150 mg/mL prefilled syringe or prefilled pen for
subcutaneous use
Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless toyellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg ofrisankizumab-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 75 mg/0.83 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 75 mg of risankizumab-rzaa, andthe inactive ingredients sodium succinate (0.53 mg), polysorbate 20 (0.17 mg), sorbitol (34 mg),
succinic acid (0.049 mg), and Water for Injection, USP. The pH is 6.2.
SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use
with the supplied on-body injector for subcutaneous use
Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, andclear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, andthe 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, preservativefree, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dosevial.
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 (633.3mg), and Water for Injection, USP. The pH is 5.7.
12 CLINICAL PHARMACOLOGY
12.1 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 anaturally occurring cytokine that is involved in inflammatory and immune responses.
Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.

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12.2 Pharmacodynamics
No formal pharmacodynamics studies have been conducted with risankizumab-rzaa.
12.3 Pharmacokinetics
Risankizumab-rzaa plasma concentrations, after single dose administration increased dose
proportionally from 18 mg to 360 mg when administered subcutaneously (0.05-2.4 times thelowest recommended dose to the highest recommended dose) and from 200 mg to 1800 mg whenadministered as an up to 3-hour intravenous infusion (0.3 to 3 times the recommended dose) in
healthy subjects.
In subjects with plaque psoriasis treated with 150 mg subcutaneously at Weeks 0, 4, and every
12 weeks thereafter, steady-state peak concentration (Cmax) and trough concentration (Ctrough) are
estimated to be 12 mcg/mL and 2 mcg/mL, respectively.
With the same dosing regimen, the pharmacokinetics of risankizumab-rzaa in subjects withpsoriatic arthritis was similar to that in subjects with plaque psoriasis.
In subjects with Crohn’s disease treated with 600 mg intravenous induction dose at Weeks 0, 4,
and 8, followed by 360 mg subcutaneous maintenance dose at Week 12 and every 8 weeks
thereafter, the median Cmax and Ctrough are estimated to be 156 mcg/mL and 38.8 mcg/mL,
respectively, during Weeks 8-12; and the steady state median Cmax and Ctrough are estimated to be
28.0 mcg/mL and 8.13 mcg/mL, respectively, during Weeks 40-48.
Absorption
The absolute bioavailability of risankizumab-rzaa was estimated to be 74 to 89% following
subcutaneous injection. In healthy subjects, following administration of a single subcutaneousdose, Cmax was reached by 3 to 14 days.
Distribution
The estimated steady-state volume of distribution (inter-subject CV%) was 11.2 L (34%) in
subjects with plaque psoriasis, and 7.68 L (64%) in subjects with Crohn’s disease.
Elimination
The estimated systemic clearance (inter-subject CV%) was 0.31 L/day (24%) and 0.30 L/day(34%) and terminal elimination half-life was approximately 28 days and 21 days in subjects withplaque psoriasis and Crohn’s disease, respectively.
Metabolism
The metabolic pathway of risankizumab-rzaa has not been characterized. As a humanized IgG1
monoclonal antibody, risankizumab-rzaa is expected to be degraded into small peptides andamino acids via catabolic pathways in a manner similar to endogenous IgG.
Specific Populations
No clinically significant differences in the pharmacokinetics of risankizumab-rzaa were observed
based on age (≥18 years). Risankizumab-rzaa exposures (Ctrough) in geriatric patients (≥65 years)
are comparable to those in younger adult patients with Crohn’s disease. No studies have been

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conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics ofrisankizumab-rzaa.
Body Weight
Risankizumab-rzaa clearance and volume of distribution increase and plasma concentrations
decrease as body weight increases; however, no dose adjustment is recommended based on bodyweight.
Drug Interaction Studies
Cytochrome P450 Substrates
No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin(CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate), or
midazolam (CYP3A substrate) were observed when used concomitantly with risankizumab-rzaa
150 mg administered subcutaneously at Weeks 0, 4, 8 and 12 (more frequent than the approved
recommended dosing frequency) in subjects with plaque psoriasis.
Clinical drug interactions have not been evaluated in subjects with Crohn’s disease at therecommended dosage.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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 10 times the exposure(AUC) in humans administered the 600 mg induction regimen for Crohn’s disease, and 3.9 times
the exposure in humans administered the 360 mg maintenance regimen for Crohn’s disease,respectively.
14 CLINICAL STUDIES
14.1 Plaque Psoriasis
Four multicenter, randomized, double-blind studies [PsO-1 (NCT02684370), PsO-2(NCT02684357), PsO-3 (NCT02672852), and PsO-4 (NCT02694523)] enrolled 2109 subjects
18 years of age and older with moderate to severe plaque psoriasis who had a body surface area
(BSA) involvement of ≥10%, a static Physician’s Global Assessment (sPGA) score of ≥3(“moderate”) in the overall assessment (plaque thickness/induration, erythema, and scaling) of
psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score ≥12.
Overall, subjects had a median baseline PASI score of 17.8 and a median BSA of 20%. BaselinesPGA score was 4 (“severe”) in 19% of subjects. A total of 10% of study subjects had a historyof diagnosed psoriatic arthritis.

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Across all studies, 38% of subjects had received prior phototherapy, 48% had received prior nonbiologic systemic therapy, and 42% had received prior biologic therapy for the treatment ofpsoriasis.
Studies PsO-1 and PsO-2
In studies PsO-1 and PsO-2, 997 subjects were enrolled (including 598 subjects randomized to
the SKYRIZI 150 mg group, 200 subjects randomized to the placebo group, and 199 to the
biologic active control group). Subjects received treatment at Weeks 0, 4, and every 12 weeks
thereafter.
Both studies assessed the responses at Week 16 compared with placebo for the two co-primary
endpoints:• the proportion of subjects who achieved an sPGA score of 0 (“clear”) or 1 (“almost clear”)• the proportion of subjects who achieved at least a 90% reduction from baseline PASI(PASI 90)
Secondary endpoints included the proportion of subjects who achieved PASI 100, sPGA 0, andPsoriasis Symptom Scale (PSS) 0 at Week 16.
The results are presented in Table 4.
Table 4. Efficacy Results at Week 16 in Adults with Plaque Psoriasis in PsO-1 and PsO-2
PsO-1
PsO-2
SKYRIZI
Placebo
SKYRIZI
Placebo(N=304)(N=102)(N=294)(N=98)
n (%)
n (%)
n (%)
n (%)
sPGA 0 or 1(“clear or
267 (88)8 (8)246 (84)
5 (5)aalmost clear”)
PASI 90a
229 (75)5 (5)220 (75)
2 (2)sPGA 0112 (37)2 (2)150 (51)
3 (3)(“clear”)
PASI 100
109 (36)0 (0)149 (51)2 (2)aCo-primary endpoints

Examination of age, gender, race, body weight, baseline PASI score and previous treatment withsystemic or biologic agents did not identify differences in response to SKYRIZI among thesesubgroups at Week 16.
In PsO-1 and PsO-2 at Week 52, subjects receiving SKYRIZI achieved sPGA 0 (58% and 60%,
respectively), PASI 90 (82% and 81%, respectively), and PASI 100 (56% and 60%,
respectively).
Patient Reported Outcomes
Improvements in signs and symptoms related to pain, redness, itching and burning at Week 16
compared to placebo were observed in both studies as assessed by the PSS. In PsO-1 and PsO-2,

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about 30% of the subjects who received SKYRIZI achieved PSS 0 (“none”) at Week 16
compared to 1% of the subjects who received placebo.
Study PsO-3
Study PsO-3 enrolled 507 subjects (407 randomized to SKYRIZI 150 mg and 100 to placebo).
Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter.
At Week 16, SKYRIZI was superior to placebo on the co-primary endpoints of sPGA 0 or 1
(84% SKYRIZI and 7% placebo) and PASI 90 (73% SKYRIZI and 2% placebo). The respective
response rates for SKYRIZI and placebo at Week 16 were: sPGA 0 (46% SKYRIZI and 1%
placebo); PASI 100 (47% SKYRIZI and 1% placebo); and PASI 75 (89% SKYRIZI and 8%
placebo).
Maintenance and Durability of Response
In PsO-1 and PsO-2, among the subjects who received SKYRIZI and had PASI 100 at Week 16,
80% (206/258) of the subjects who continued on SKYRIZI had PASI 100 at Week 52. For PASI
90 responders at Week 16, 88% (398/450) of the subjects had PASI 90 at Week 52.
In PsO-3, subjects who were originally on SKYRIZI and had sPGA 0 or 1 at Week 28 were rerandomized to continue SKYRIZI every 12 weeks or withdrawal of therapy. At Week 52, 87%(97/111) of the subjects re-randomized to continue treatment with SKYRIZI had sPGA 0 or 1
compared to 61% (138/225) who were re-randomized to withdrawal of SKYRIZI.
14.2 Psoriatic Arthritis
The safety and efficacy of SKYRIZI were assessed in 1407 subjects in 2 randomized, doubleblind, placebo-controlled studies (964 in PsA-1 [NCT03675308] and 443 in PsA-2[NCT03671148]) in subjects 18 years and older with active psoriatic arthritis (PsA).
Subjects in these studies had a diagnosis of PsA for at least 6 months based on the Classification
Criteria for Psoriatic Arthritis (CASPAR), a median duration of PsA of 4.9 years at baseline, ≥ 5tender joints and ≥ 5 swollen joints, and active plaque psoriasis or psoriatic nail disease atbaseline. Regarding baseline clinical presentation, 55.9% of subjects had ≥3% BSA with active
plaque psoriasis; 63.4% and 27.9% of subjects had enthesitis and dactylitis, respectively. In PsA1 where psoriatic nail disease was further assessed, 67.3% had psoriatic nail disease.
In PsA-1, all subjects had a previous inadequate response or intolerance to non-biologic
DMARD therapy and were biologic naïve. In PsA-2, 53.5% of subjects had a previous
inadequate response or intolerance to non-biologic DMARD therapy, and 46.5% of subjects had
a previous inadequate response or intolerance to biologic therapy.
In both studies, subjects were randomized to receive SKYRIZI 150 mg or placebo at Weeks 0, 4,
and 16. Starting from Week 28, all subjects received SKYRIZI every 12 weeks. Both studies
included a long-term extension for up to an additional 204 weeks. Regarding use of concomitant
medications, 59.6% of subjects were receiving concomitant methotrexate (MTX), 11.6% werereceiving concomitant non-biologic DMARDs other than MTX, and 28.9% were receiving
SKYRIZI monotherapy.
For both studies, the primary endpoint was the proportion of subjects who achieved an American
College of Rheumatology (ACR) 20 response at Week 24.

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Clinical Response
In both studies, treatment with SKYRIZI resulted in significant improvement in measures of
disease activity compared with placebo at Week 24. See Tables 5 and 6 for key efficacy results.
In both studies, similar responses were seen regardless of concomitant non-biologic DMARD
use, number of prior non-biologic DMARDs, age, gender, race, and BMI. In PsA-2, responses
were seen regardless of prior biologic therapy.

Endpoint
ACR20 Response*
Week 16
Week 24
ACR50 Response*
Week 16
Week 24
ACR70 Response*
Week 16
Week 24

Table 5. Efficacy Results in Study PsA-1
Placebo
SKYRIZI
Difference from Placebo
N=481
N=483
(95% CI)
Response Rate
Response Rate
33.4%
33.5%

56.3%a
57.3%a

23.1% (16.8, 29.4)
24.0% (18.0, 30.0)

11.1%
11.3%

26.4%
33.4 %

15.4% (10.6, 20.2)
22.2% (17.3, 27.2)

2.7%
4.7%

11.8%
15.3%

9.2% (6.1, 12.4)
10.5% (6.9, 14.2)

a. multiplicity-controlled p≤0.001, SKYRIZI vs. placebo comparison.
*A Subject was considered as a non-responder after initiation of rescue medication or concomitant medications
for PsA that could meaningfully impact efficacy assessment.

Endpoint
ACR20 Response*
Week 16
Week 24
ACR50 Response*
Week 16
Week 24
ACR70 Response*
Week 16
Week 24

Table 6. Efficacy Results in Study PsA-2
Placebo
SKYRIZI
Difference from Placebo
N=219
N=224
(95% CI)
Response Rate
Response Rate
25.3%
26.5%

48.3% a51.3% a22.6% (13.9, 31.2)
24.5% (15.9, 33.0)

6.8%
9.3%

20.3%
26.3%

13.5% (7.3, 19.7)
16.6% (9.7, 23.6)

3.4%
5.9%

11.2%
12.0%

7.8% (3.0, 12.6)
6.0% (0.8, 11.3)

a. multiplicity-controlled p≤0.001, SKYRIZI vs. placebo comparison.
*A Subject was considered as a non-responder after initiation of rescue medication or concomitant medications
for PsA that could meaningfully impact efficacy assessment.

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The percent of subjects achieving ACR20 responses in study PsA-1 through Week 24 is shownin Figure 1.
Figure 1. Percent of Subjects Achieving ACR20 Responses in Study PsA-1 through Week 24

The results of the components of the ACR response criteria for both studies are shown in Table 7.
Table 7. Mean Change from Baseline in ACR Components
PsA-1
Placebo(N=481)
Mean (SD)
Number of Swollen Joints (0-66)
Baseline
12.2 (8.0)
Mean change at Week 16-5.5 (7.0)
Mean change at Week 24-6.7 (7.2)
Number of Tender Joints (0-68)
20.5 (12.8)
Baseline
Mean change at Week 16
Mean change at Week 24
Patient’s Assessment of Pain a

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SKYRIZI(N=483)
Mean (SD)

PsA-2
Placebo
SKYRIZI(N=219)(N=224)
Mean (SD) Mean (SD)12.1 (7.8)-7.7 (7.2)-8.7 (7.2)

13.6 (9.0)-5.4 (8.5)-6.5 (7.8)

13.0 (8.7)-8.0 (7.4)-9.1 (7.6)

20.8 (14.0)

22.3 (13.8)

22.8 (14.9)-10.7 (11.4)-12.0 (12.3)-6.0 (13.1)-8.3 (11.3)-11.3 (13.0)-13.0 (12.5)

Baseline
57.1 (22.6)
57.1 (22.6)
57.0 (23.1)
Mean change at Week 16-8.6 (23.7)-18.4 (26.3)-5.7 (22.7)
Mean change at Week 24-10.9 (25.4)-21.4 (26.5)-8.7 (25.3)
Patient’s Global Assessment a
Baseline
57.4 (22.1)
57.9 (21.7)
56.2 (23.0)
Mean change at Week 16-10.2 (23.9)-19.4 (25.7)-4.9 (23.6)
Mean change at Week 24-11.1 (25.1)-22.6 (26.9)-8.7 (25.4)
aPhysician Global Assessment
Baseline
62.4 (17.0)
61.3 (17.6)
60.7 (16.4)
Mean change at Week 16-18.3 (22.5)-31.1 (23.4) -19.0 (23.3)
Mean change at Week 24-22.2 (22.8)-34.8 (23.2) -21.3 (25.2)
Health Assessment Questionnaire - Disability Index (HAQ-DI) b
Baseline
1.2 (0.7)
1.2 (0.7)
1.1 (0.6)
Mean change at Week 16-0.1 (0.5)-0.3 (0.5)-0.1 (0.5)
Mean change at Week 24-0.1 (0.5)-0.3 (0.5)-0.1 (0.4)
High sensitivity C-reactive protein (hs-CRP) mg/L
Baseline
11.3 (14.1)
11.9 (15.9)
8.2 (17.1)
Mean change at Week 16-0.3 (14.7)-4.8 (14.2)-0.1 (6.8)
Mean change at Week 24-0.2 (11.7)-4.3 (12.8)-0.5 (14.5)

55.0 (23.5)-14.4 (26.4)-15.3 (26.5)
56.2 (21.8)-17.0 (27.1)-17.7 (27.7)
63.0 (17.0)-32.7 (24.7)-35.5 (25.6)
1.1 (0.6)-0.2 (0.5)-0.2 (0.5)
7.4 (10.9)-2.1 (7.5)-1.8 (13.4)

SD= Standard Deviation.
a. Assessment based on Visual Analog Scale (100 mm) with the left end indicating “no pain” (for patient’s
assessment of pain), “very well” (for patient global assessment), or “no arthritis activity” (for physician global
assessment) and the right end indicating “the worst possible pain” (for patient assessment of pain), “poor” (forpatient global assessment), or “extremely active arthritis” (for physician global assessment).
b. Disability Index of the Health Assessment Questionnaire; 0 = no difficulty to 3 = inability to perform, measures
the patient’s ability to perform the following: dressing, arising, eating, walking, hygiene, reaching, gripping, andactivities of daily living.

Treatment with SKYRIZI resulted in improvement in dactylitis and enthesitis in subjects withpre-existing dactylitis or enthesitis.
In patients with coexistent plaque psoriasis receiving SKYRIZI, the skin lesions of psoriasis
improved with treatment, relative to placebo, as measured by the Psoriasis Area Severity Index(PASI 90) at Week 24.
Physical Function
In both studies, patients treated with SKYRIZI showed statistically significant improvementfrom baseline in physical function compared with placebo as assessed by HAQ-DI at Week 24(Table 5). The mean difference (95% CI) from placebo in HAQ-DI change from baseline at
Week 24 was -0.20 (-0.26, -0.14) in study PsA-1 and -0.16 (-0.26, -0.07) in study PsA-2.
In both studies, a greater proportion of subjects achieved a reduction of at least 0.35 in HAQ-DI
score from baseline in the SKYRIZI group compared with placebo at Week 24.

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Other Health Related Outcomes
In both studies, general health status was assessed by the 36-Item Short Form Health Survey (SF36 V2). Fatigue was assessed by Functional Assessment of Chronic Illness Therapy Fatigue
Scale (FACIT-Fatigue).
In both studies at Week 24, subjects treated with SKYRIZI showed improvements in the SF-36
physical component summary scores compared with subjects who received placebo. There werealso numerical improvements in subjects treated with SKYRIZI in physical functioning, rolephysical, bodily pain, general health, vitality, social functioning, mental health, role emotional
domain scores and mental component summary scores in both studies at week 24 compared toplacebo. In both studies at Week 24, subjects treated with SKYRIZI showed improvements in
FACIT-Fatigue scores compared with subjects who received placebo.
14.3 Crohn’s Disease
Induction Trials (Studies CD-1 and CD-2)
In two 12-week induction studies (CD-1; NCT03105128 and CD-2; NCT03104413), subjects
with moderately to severely active Crohn’s disease were randomized to receive SKYRIZI 600
mg, SKYRIZI 1,200 mg, or placebo as an intravenous infusion at Week 0, Week 4, and Week 8.
Moderately to severely active CD was defined as a Crohn’s Disease Activity Index (CDAI) of
220 to 450 and Simple Endoscopic Score for Crohn’s disease (SES-CD) ≥6 (or ≥4 for isolated
ileal disease). Subjects with inadequate response, loss of response, or intolerance to oralaminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapy were enrolled.
At baseline, the median CDAI was 307 (range: 76 – 634) and 307 (range: 72 – 651), and the
median SES-CD was 12 (range: 4 – 45) and 13 (range 4 – 40), in CD-1 and CD-2, respectively.
In CD-1, 58% (491/850) of subjects had failed or were intolerant to treatment with one or morebiologic therapies (prior biologic failure). All subjects in CD-2 had prior biologic failure. At
baseline, 30% and 34% of patients were receiving corticosteroids, 24% and 23% of patients werereceiving immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), and 31% and 19%
of patients were receiving aminosalicylates in CD-1 and CD-2, respectively. In CD-1 and CD-2
combined, the median age was 36 years (ranging from 16 to 80 years), 81% (1145/1419) of
subjects were white, and 53% (753/1419) were male.
In CD-1 and CD-2, the co-primary endpoints were clinical remission and endoscopic response at
Week 12. Secondary endpoints included clinical response and endoscopic remission (see Table 8
and Table 9). The SKYRIZI 1,200 mg dosage did not demonstrate additional treatment benefit
over the 600 mg dosage and is not a recommended regimen [see Dosage and Administration(2.6)].

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Table 8. Proportion of Subjects Meeting Efficacy Endpoints at Week 12 – Study CD-1
Placebo

SKYRIZI
600 mg
Intravenous
Infusiona

Treatment
Difference b(95% CI)

Total Population

N=175
25%

N=336
45%

21% e
(12%, 29%)

Prior biologic failuref

N=97
26%

N=195
42%

Without prior biologic failure

N=78
23%

N=141
49%

Total Population

N=175
12%

N=336
40%

Prior biologic failuref

N=97
11%

N=195
33%

Without prior biologic failure

N=78
13%

N=141
50%

Total Population

N=175
37%

N=336
60%

Prior biologic failuref

N=97
34%

N=195
58%

Without prior biologic failure

N=78
40%

N=141
62%

Total Population

N=175
9%

N=336
24%

Prior biologic failuref

N=97
5%

N=195
18%

Without prior biologic failure

N=78
14%

N=141
32%

Endpoint

Clinical Remissionc,dEndoscopic Responsec,g28% e(21%, 35%)

Clinical Responseh
23% e(14%, 32%)

Endoscopic Remissioni

Reference ID: 5000374

15% e(9%, 21%)

a. SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8
b. Adjusted treatment difference (95% CI) based on Cochran-Mantel-Haenszel method adjusted for
randomization stratification factors
c. Co-primary endpoints
d. CDAI <150
e. p <0.001
f. Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologic
treatments for CD
g. A decrease in SES-CD > 50% from baseline, or a decrease of at least 2 points for subjects with a baseline
score of 4 and isolated ileal disease, based on central readingh. A reduction of CDAI ≥ 100 points from baseline
i. SES-CD ≤ 4 and at least a 2-point reduction from baseline, with no individual subscore greater than 1, basedon central reading

Table 9. Proportion of Subjects Meeting Efficacy Endpoints at Week 12 – Study CD-2a
Placebo
N=187

SKYRIZI
600 mg
Intravenous
Infusionb
N=191

20%

42%

22% f
(13%, 31%)

11%

29%

18% f
(10%, 25%)

30%

60%

29% f
(20%, 39%)

4%

19%

15% f
(9%, 21%)

Endpoint

Clinical Remissiond,eEndoscopic Response d,gClinical Responseh
Endoscopic Remissioni

Treatment
Differencec(95% CI)a. All subjects enrolled in CD-2 had prior biologic failure. Prior biologic failure includes inadequate response,
loss of response, or intolerance to one or more biologic treatments for CD
b. SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8c. Adjusted treatment difference (95% CI) based on Cochran-Mantel-Haenszel method adjusted for
randomization stratification factors
d. Co-primary endpoints
e. CDAI score <150
f. p < 0.001
g. A decrease in SES-CD > 50% from baseline, or a decrease of at least 2 points for subjects with a baseline
score of 4 and isolated ileal disease, based on central readingh. A reduction of CDAI ≥ 100 points from baseline
i. SES-CD ≤ 4 and at least a 2-point reduction versus from baseline, with and no individual subscore greater than
1, based on central reading

Onset of clinical response and clinical remission based on CDAI occurred as early as Week 4 ina greater proportion of subjects treated with the SKYRIZI 600 mg induction regimen comparedto placebo.

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Reductions in stool frequency and abdominal pain were observed in a greater proportion ofsubjects treated with the SKYRIZI 600 mg induction regimen compared to placebo.
Study CD-3
The maintenance study CD-3 evaluated 247 subjects who achieved clinical response defined as a
reduction in CDAI of at least 100 points from baseline after 12 weeks of induction treatment
with intravenous SKYRIZI in studies CD-1 and CD-2. Subjects were randomized to receive amaintenance regimen of SKYRIZI 360 mg or placebo at Week 12 and every 8 weeks thereafter
for up to an additional 52 weeks.
The co-primary endpoints in CD-3 were clinical remission and endoscopic response at Week 52(see Table 10).
Table 10. Proportion of Subjects Meeting Efficacy Endpoints at Week 52 - Study CD-3
Placeboa

SKYRIZI
360 mgSubcutaneous
Injectionb

Treatment Difference vsPlaceboc(95% CI)

Total Population

N=130
46%

N=117
57%

14% f
(3%, 26%)

Prior biologic failureg

N=99
40%

N=83
51%

Without prior biologic failure

N=31
65%

N=34
71%

Total Population

N=130
22%

N=117
48%

Prior biologic failureg

N=99
21%

N=83
44%

Without prior biologic failure

N=31
23%

N=34
59%

Endpoint

Clinical Remissiond,eEndoscopic Responsed,h31% f(21%, 41%)

a. The placebo group consisted of patients who were in response to SKYRIZI and were randomized to receive
placebo at the start of maintenance therapy.
b. SKYRIZI 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks
c. Adjusted treatment difference and 95% CI computed using Cochran-Mantel-Haenszel method adjusted for
randomization stratification factors
d. Co-primary endpoints
e. CDAI <150
f. p <0.05
g. Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologic
treatments for CD
h. A decrease in SES-CD > 50% from baseline, or a decrease of at least 2 points for subjects with a baseline
score of 4 and isolated ileal disease, based on central reading

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Endoscopic remission was observed at Week 52 in 41% (48/117) of subjects treated with the
SKYRIZI maintenance regimen and 13% (17/130) of subjects treated with placebo. This
endpoint was not statistically significant under the prespecified multiple testing procedure.
16 HOW SUPPLIED/STORAGE AND HANDLINGHow Supplied
SKYRIZI (risankizumab-rzaa) injection is supplied in the following strengths:
Strength
Subcutaneous Injection
150 mg/mL single-dose pen
150 mg/mL single-dose prefilled syringe
75 mg/0.83 mL single-dose prefilled syringe
360 mg/2.4 mL (150 mg/mL) single-dose
prefilled cartridge with on-body injector
Intravenous Infusion
600 mg/10 mL (60 mg/mL) single-dose vial

Pack Size

NDC

Carton of 1
Carton of 1
Carton of 2
Kit

0074-2100-01
0074-1050-01
0074-2042-02
0074-1070-01

Carton 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 75 mg/0.83 mL prefilled syringe is 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 360 mg/2.4 mL (150 mg/mL) cyclic olefin polymer prefilled cartridge with a septumand cap contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescentsolution 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 toslightly yellow, and clear to slightly opalescent solution. Each glass vial is closed with a stopperand 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.

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17 PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication
Guide and Instructions for Use).
Hypersensitivity Reactions
Advise patients to discontinue SKYRIZI and seek immediate medical attention if theyexperience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions(5.1)].
Infections
Inform patients that SKYRIZI may lower the ability of their immune system to fight infections.
Instruct patients of the importance of communicating any history of infections to the healthcare
provider and contacting their healthcare provider if they develop any symptoms of an infection[see Warnings and Precautions (5.2)].
Hepatotoxicity in Treatment of Crohn’s Disease
Inform patients that SKYRIZI may cause liver injury, especially during the initial 12 weeks oftreatment. Instruct patients to seek immediate medical attention if they experience symptoms
suggestive of liver dysfunction. (e.g., unexplained rash, nausea, vomiting, abdominal pain,
fatigue, anorexia, or jaundice and/or dark urine) [see Warnings and Precautions (5.4)].
Administration of Vaccines
Advise patients that vaccination with live vaccines is not recommended during SKYRIZI
treatment and immediately prior to or after SKYRIZI treatment. Medications that interact with
the immune system may increase the risk of infection following administration of live vaccines.
Instruct patients to inform the healthcare practitioner that they are taking SKYRIZI prior to apotential vaccination [see Warnings and Precautions (5.5)].
Administration Instruction
Instruct patients or caregivers to perform the first self-injected dose under the supervision andguidance of a qualified healthcare professional for training in preparation and administration of
SKYRIZI, including choosing anatomical sites for administration, and proper subcutaneous
injection technique [see Instructions for Use].
If using SKYRIZI 75 mg/0.83 mL, instruct patients or caregivers to administer two 75 mg
single-dose syringes to achieve the full 150 mg dose of SKYRIZI [see Instructions for Use].
Instruct patients or caregivers in the technique of pen or syringe disposal [see Instructions for
Use].
Pregnancy
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women
exposed to SKYRIZI during pregnancy and patients can call 1-877-302-2161 [see Use inSpecific Populations (8.1)].

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Manufactured by:
AbbVie Inc.
North Chicago, IL 60064, USA
US License Number 1889
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
© 2019-2022 AbbVie Inc.
20070464 06/2022

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Medication Guide
SKYRIZI® (sky-RIZZ-ee)(risankizumab-rzaa)
injection, for subcutaneous or intravenous use
What is the most important information I should know about SKYRIZI?
SKYRIZI may cause serious side effects, including:
Serious allergic reactions. Stop using SKYRIZI and get emergency medical help right away if you get any of thefollowing symptoms of a serious allergic reaction:
 fainting, dizziness, feeling lightheaded (low blood pressure) chest tightness
 swelling of your face, eyelids, lips, mouth, tongue, or throat
 skin rash, hives
 trouble breathing or throat tightness
 itching
Infections. SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk ofinfections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment withSKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active
TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment withSKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills
 muscle aches
 weight loss cough warm, red, or painful skin or diarrhea or stomach pain
sores on your body different from  burning when you urinate or shortness of breath
your psoriasis
urinating more often than blood in your mucus (phlegm)
normalSee “What are the possible side effects of SKYRIZI?” for more information about side effects.
What is SKYRIZI?
SKYRIZI is a prescription medicine used to treat: moderate to severe plaque psoriasis in adults who may benefit from taking injections or pills (systemic therapy) or
treatment using ultraviolet or UV light (phototherapy).
 active psoriatic arthritis in adults.
 moderate to severe Crohn’s disease in adults.
It is not known if SKYRIZI is safe and effective in children under 18 years of age.
Who should not use SKYRIZI?
Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the end of thisMedication Guide for a complete list of ingredients in SKYRIZI.
Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section “What is the most important information I should
know about SKYRIZI?” have an infection that does not go away or that keeps coming back.
 have TB or have been in close contact with someone with TB.
 have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the
immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid
receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider thatyou are taking SKYRIZI before receiving a vaccine.
 are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
 are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.
 If you become pregnant while taking SKYRIZI, you are encouraged to enroll in the Pregnancy Registry. The
purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to yourhealthcare provider or call 1-877-302-2161 to enroll in this registry.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
How should I use SKYRIZI?
See the detailed “Instructions for Use” that comes with SKYRIZI for information on how to prepare and inject adose of SKYRIZI, and how to properly throw away (dispose of) a used SKYRIZI prefilled pen, prefilled syringe,or prefilled cartridge with on-body injector.
 Use SKYRIZI exactly as your healthcare provider tells you to use it.
 Your healthcare provider will tell you how much SKYRIZI is right for you and how often you should receive it.
 Before self-injecting with SKYRIZI prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector, yourhealthcare provider should show you how to inject SKYRIZI.

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

If you miss your SKYRIZI dose, inject a dose as soon as you remember. Then, take your next dose at your regularscheduled time. Call your healthcare provider if you are not sure what to do.
 If you inject more SKYRIZI than prescribed, call your healthcare provider right away.
Adults with plaque psoriasis or psoriatic arthritis will receive SKYRIZI as an injection under the skin (subcutaneous
injection) using the prefilled pen or prefilled syringe.
Adults with Crohn’s disease will receive their starter doses with SKYRIZI through a vein in the arm (intravenous
infusion) in a healthcare facility by a healthcare provider. After completing the starter doses, patients will receive
SKYRIZI as an injection under the skin (subcutaneous injection) using the prefilled cartridge with on-body injector.
What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects including: See “What is the most important information I should know about SKYRIZI?” Liver problems in Crohn’s disease. A person with Crohn’s disease who received SKYRIZI by intravenous
infusion (through a vein in the arm) developed changes in liver blood tests with a rash that led to hospitalization.
Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment withSKYRIZI. Your healthcare provider may stop treatment with SKYRIZI if you develop liver problems. Tell yourhealthcare provider right away if you notice any of the following symptoms:
o unexplainedo vomitingo tiredness (fatigue) o yellowing of the skin andrasheyes (jaundice)o nauseao stomach (abdominal) paino loss of appetiteo dark urine
The most common side effects of SKYRIZI in people treated for Crohn’s disease include: upper respiratory infections
 headache joint pain injection site reactions
 stomach (abdominal) pain low red blood cells(anemia) fever
 back pain
The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections
 feeling tired injection site reactions
 headache fungal skin infections

These are not all the possible side effects of SKYRIZI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SKYRIZI?
 Store SKYRIZI in the refrigerator between 36°F to 46°F (2°C to 8°C).
 Do not freeze SKYRIZI.
 Do not shake SKYRIZI.
 Keep SKYRIZI in the original carton to protect it from light.
 SKYRIZI is not made with natural rubber latex.
Keep SKYRIZI and all medicines out of the reach of children.
General information about the safe and effective use of SKYRIZI.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SKYRIZI
for a condition for which it was not prescribed. Do not give SKYRIZI to other people, even if they have the same
symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about
SKYRIZI that is written for health professionals.
What are the ingredients in SKYRIZI?
Active ingredient: risankizumab-rzaa.
SKYRIZI 150 mg/mL, 360 mg/2.4 mL, and 600 mg/ 10 mL inactive ingredients: glacial acetic acid, polysorbate 20,
sodium acetate, trehalose, and Water for Injection, USP.
SKYRIZI 75 mg/0.83 mL inactive ingredients: sodium succinate, polysorbate 20, sorbitol, succinic acid, and Water for
Injection, USP.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
© 2019-2022 AbbVie Inc.
For more information, call 1-866-SKYRIZI (1-866-759-7494) or go to www.SKYRIZI.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration

Reference ID: 5000374

Revised: 06/2022

INSTRUCTIONS FOR USE
SKYRIZI® (sky-RIZZ-ee) Pen(risankizumab-rzaa)
injection, for subcutaneous use
Read Before First Use
Refer to the Medication Guide for product information.
Read this Instructions for Use before using SKYRIZI Pen (risankizumab-rzaa) injection.
Before using SKYRIZI, you should receive training from your healthcare provider on how to inject
SKYRIZI.
SKYRIZI Single-Dose Pen

Important Information• Store SKYRIZI in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep SKYRIZI in the original carton to protect from light until you are ready to use.
• Before injecting, take the SKYRIZI carton out of the refrigerator. Leave the carton at room
temperature and out of direct sunlight for 30 to 90 minutes.

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• The liquid in the inspection window should look clear to yellow and may contain tiny white or clear
particles.
• Do not use SKYRIZI if the liquid is cloudy or contains flakes or large particles.
• Do not use SKYRIZI if the expiration date (EXP) has passed.
• Do not use SKYRIZI if the liquid has been frozen, even if it has been thawed.
• Do not shake SKYRIZI.
• Do not use if the SKYRIZI Pen has been dropped or damaged.
• Do not use SKYRIZI if carton perforations are broken. Return product to pharmacy.
• Do not remove the dark gray cap until right before injection.
• SKYRIZI is not made with natural rubber latex.

Prepare SKYRIZI injection
Take the SKYRIZI carton out of the refrigerator. Leave
the carton at room temperature and out of direct
sunlight for 30 to 90 minutes before injecting.
• Do not remove the Pen from the carton whileallowing 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 the Pen if the liquid has been frozen,
even if it has been thawed.

Check expiration date (EXP). Do not use the Pen if
expiration date has passed.
Place the following on a clean, flat surface:• 1 single-dose SKYRIZI Pen (included)• 1 alcohol swab (not included)• 1 cotton ball or gauze pad (not included)• FDA-cleared sharps disposal container (notincluded). See “Used SKYRIZI Prefilled Pen
Disposal” for information on how to throw away
(dispose of) used Pens.
Wash and dry your hands.

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Choose an injection site:• on the front of your thighs or• your abdomen (belly) at least 2 inches from yournavel (belly button)
Wipe the injection site in a circular motion with thealcohol swab and let it dry.
• Do not touch or blow on the injection site after it iscleaned. Allow the skin to dry before injecting.
• Do not inject through clothes.
• Do not inject into skin that is sore, bruised, red,
hard, scarred, has stretch marks, or areas withpsoriasis.

Hold the Pen with the dark gray cap pointing up.
• Pull the dark gray cap straight off.
• Throw the dark gray cap away.
Check the liquid through the inspection window.
• It is normal to see 1 or more bubbles in the liquid.
• The liquid should look clear to yellow and may
contain tiny white or clear particles.
• Do not use if the liquid is cloudy or contains flakes
or large particles.

Give SKYRIZI injection
Hold the Pen with your fingers on the gray hand grips.
Turn the Pen so that the white needle sleeve points
toward the injection site and you can see the green
activator button.
Pinch the skin at your injection site to make a raisedarea and hold it firmly.
Place the white needle sleeve straight (90-degree
angle) against the raised injection site.

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Hold the Pen so that you can see the green activator
button and inspection window.
Push and keep pressing the Pen down against theraised injection site.
• The Pen will activate only if the white needle sleeve
is pressed down against the injection site before
pressing the green activator button.
Press the green activator button and hold the Pen for
15 seconds.
• The first loud “click” means the start of the injection.

Keep pressing the Pen down against the injection
site.
The injection is complete when:• the Pen has made a second “click” or• the yellow indicator has filled the inspection window
This takes up to 15 seconds.

After SKYRIZI injection
When the injection is complete, slowly pull the Penstraight out from the skin.
The white needle sleeve will cover the needle tip andmake another “click.”
After completing the injection, place a cotton ball or
gauze pad on the skin at the injection site.
• Do not rub the injection site.
• Slight bleeding at the injection site is normal.

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Throw away (dispose of) the used Pen in a FDAcleared sharps disposal container right away afteruse.
• Do not dispose of used Pens in your household
trash unless your community guidelines permit this.
• Do not recycle your sharps disposal container.
The dark gray cap, alcohol swab, cotton ball or gauze
pad, and packaging may be placed in your household
trash.
For more information, see “Used SKYRIZI Prefilled
Pen Disposal”.

Important Information• Store SKYRIZI in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep SKYRIZI in the original carton to protect from light until you are ready to use.
• Before injecting, take the SKYRIZI carton out of the refrigerator. Leave the carton at room
temperature and out of direct sunlight for 30 to 90 minutes.
• The liquid in the inspection window should look clear to yellow and may contain tiny white or clear
particles.
• Do not use SKYRIZI if the liquid is cloudy or contains flakes or large particles.
• Do not use SKYRIZI if the expiration date (EXP) has passed.
• Do not use SKYRIZI if the liquid has been frozen, even if it has been thawed.
• Do not shake SKYRIZI.
• Do not use if the SKYRIZI Pen has been dropped or damaged.
• Do not use SKYRIZI if carton perforations are broken. Return product to pharmacy.
• Do not remove the dark gray cap until right before injection.
• SKYRIZI is not made with natural rubber latex.
Keep the SKYRIZI Pen and sharps disposal container out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help or do not know how toproceed.
Questions About Using the SKYRIZI Pen
Q. What if I need help on how to inject SKYRIZI?
A. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help.
Q. I have removed the dark gray cap and pressed the green activator button. Why isn’t myinjection starting?
A. The green activator button will not start the injection unless the white needle sleeve is pressed firmly
against the injection site.
Q. How do I know when the injection is complete?
A. The injection is complete if the Pen makes a second “click” or the yellow indicator fills the inspection
window. This takes up to 15 seconds.
Q. What should I do if there are more than a few drops of liquid on the injection site?
A. Call (866) SKYRIZI or (866) 759-7494 for help.
Q. What should I do with the used Pen after my injection?

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A. Dispose of the used Pen in a sharps disposal container right after use. Do not dispose of the used
Pen in your household trash.
You can sign up to receive sharps containers for SKYRIZI Pen disposal at no additional cost by goingto www.SKYRIZI.com or calling (866) SKYRIZI or (866) 759-7494.
Call (866) SKYRIZI or (866) 759-7494 or go to www.SKYRIZI.com for help with your injection.

To help remember when to inject, mark your calendar with the date you give your
SKYRIZI injection.

Keep the SKYRIZI Pen and sharps disposal container out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help or have questions
about the use of SKYRIZI.
Used SKYRIZI Prefilled Pen Disposal
If you do not have a FDA-cleared sharps disposal container, you may use a household containerthat 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 forthe right way to dispose of your sharps disposal container. There may be state or local laws about how
you should throw away used Pens.
For more information about safe sharps disposal, and for specific information about sharps disposal in thestate that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
© 2019-2022 AbbVie Inc.
20071035
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 01/2022

Reference ID: 5000374

INSTRUCTIONS FOR USE
SKYRIZI® (sky-RIZZ-ee)(risankizumab-rzaa)
injection, for subcutaneous use
150 mg/mL prefilled syringe
Read Before First Use
Refer to the Medication Guide for product information.
SKYRIZI Single-Dose Prefilled Syringe

Important Information• Keep SKYRIZI in the original carton to protect from light until time to use.
• The liquid should look clear to yellow and may contain tiny white or clear particles.
• Do not use SKYRIZI if the liquid is cloudy or contains flakes or large particles.
• Do not use SKYRIZI if the expiration date (EXP:) shown on the carton and prefilled syringe has
passed.
• Do not use SKYRIZI if the liquid has been frozen (even if thawed).
• Do not shake SKYRIZI.
• Do not use SKYRIZI if the prefilled syringe has been dropped or damaged.
• Do not use SKYRIZI if carton perforations are broken. Return product to the pharmacy.
• Do not remove the needle cover until right before giving the injection.
Keep SKYRIZI and all medicines out of the reach of children.
Please Read Complete Instructions for Use Before Using SKYRIZI Prefilled Syringe
Before Injecting• Receive training on how to inject SKYRIZI before giving injection. Call your healthcare provider or(866) SKYRIZI or (866) 759-7494 if you need help.
• Mark your calendar ahead of time to remember when to take SKYRIZI.
• Leave the carton at room temperature and out of direct sunlight for 15 to 30 minutes to warm.
• Do not remove the syringe 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).
Important Information• The liquid should look clear to yellow and may contain tiny white or clear particles.
• Do not use SKYRIZI if the liquid is cloudy or contains flakes or large particles.

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• Do not use SKYRIZI if the expiration date (EXP:) shown on the carton and prefilled syringe has
passed.
• Do not use SKYRIZI if the syringe has been dropped or damaged.
• Do not use SKYRIZI if carton perforations are broken. Return product to the pharmacy.
Storage Information• Store SKYRIZI in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not shake SKYRIZI.
• Keep SKYRIZI in the original carton to protect from light until time to use.
• SKYRIZI is not made with natural rubber latex.
• Do not use if the liquid has been frozen (even if thawed).
Keep SKYRIZI and all medicines out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help or do not know how toproceed.

Gather the supplies for the injection.
• Do not hold or pull the plunger rod when removing theprefilled syringe from the sleeve.
Place the following on a clean, flat surface:• 1 prefilled syringe (included)• 1 alcohol swab (not included)• 1 cotton ball or gauze pad (not included)• FDA-cleared sharps disposal container (not included).
See “Used SKYRIZI Prefilled Syringe Disposal” for
information on how to throw away (dispose of) usedprefilled syringes.
Wash and dry your hands.
Remove prefilled syringe from cardboard sleeve by holding
the finger grip.

Reference ID: 5000374

Pick from the 3 injectable areas:• Front of left thigh or right thigh• Your abdomen (belly) at least 2 inches from your navel(belly button)
Wipe the injection site in a circular motion with the alcoholswab before the injection.
• Do not touch or blow on the injection site after it iscleaned. Allow the skin to dry before injecting.
• Do not inject through clothes.
• Do not inject into skin that is sore, bruised, red, hard,scarred, or has stretch marks, or into areas affected bypsoriasis.

Hold the prefilled syringe with covered needle facing down,
as shown.
Check the liquid in the prefilled syringe.
• It is normal to see 1 or more bubbles in the window.
• The liquid should look clear to yellow and may containtiny white or clear particles.
• Do not use the prefilled syringe if the liquid is cloudy orcontains flakes or large particles.

Remove the needle cover.
• Hold the prefilled syringe in 1 hand between the finger
grip and needle cover.
• With the other hand, gently pull the needle cover straightoff.
• Do not hold or pull the plunger rod when removing theneedle cover.
• You may see a drop of liquid at the end of the needle.
This is normal.
• Throw away the needle cover.
• Do not touch the needle with your fingers or let theneedle touch anything.
Hold the body of the prefilled syringe in 1 hand between the
thumb and index fingers.
Pinch the area of cleaned skin with your other hand andhold it firmly.
Insert the needle into the skin at about a 45-degree angle
using a quick, short movement. Hold angle steady.

Reference ID: 5000374

Slowly push the plunger rod all the way in until all of theliquid is injected, and the prefilled syringe is empty.
Pull the needle out of the skin while keeping the prefilled
syringe at the same angle.
Release the plunger rod and allow the prefilled syringe tomove up until the entire needle is covered by the needle
guard.
The prefilled syringe needle guard will not activate
unless all the liquid has been injected.
• Press a cotton ball or gauze pad over the injection siteand hold for 10 seconds.
• Do not rub the injection site. You may have slight
bleeding. This is normal.
Put your used prefilled syringe in a FDA-cleared sharps
disposal container right away after use.
• Do not throw away (dispose of) the used prefilled
syringe in the household trash.
For more information, see “Used SKYRIZI Prefilled
Syringe Disposal” section.

Questions About Using SKYRIZIQ. What if I need help on how to inject SKYRIZI?
A. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help.
Q.
A.

What should I do with the used prefilled syringe after my injection?
Throw away (dispose of) the used prefilled syringe in a sharps disposal container and not yourhousehold trash.
You can sign up to receive sharps containers for SKYRIZI syringe disposal at no additional cost by
going to www.SKYRIZI.com or calling (866) SKYRIZI or (866) 759-7494.

Q.
A.

How do I know when the injection is complete?
The injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way
in, and the syringe needle guard is activated.

Used SKYRIZI Prefilled Syringe Disposal
If you do not have a FDA-cleared sharps disposal container, you may use a household containerthat 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 forthe 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.

Reference ID: 5000374

For more information about safe sharps disposal, and for specific information about sharps disposal in thestate that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
© 2019-2022 AbbVie Inc.
20071033
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 01/2022

Reference ID: 5000374

Instructions for Use
SKYRIZI® (sky-RIZZ-ee)(risankizumab-rzaa)
injection, for subcutaneous use
75 mg/0.83 mL prefilled syringe
Read Before First Use
Refer to the Medication Guide for product information.
SKYRIZI Single-Dose Prefilled Syringe

Important Information:• Keep SKYRIZI in the original carton to protect from light until time to use.
• The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
• Do not use SKYRIZI if the liquid is cloudy or contains flakes or large particles.
• Do not use SKYRIZI if the expiration date (EXP:) shown on the carton and prefilled syringe has
passed.
• Do not use SKYRIZI if the liquid has been frozen (even if thawed).
• Do not shake SKYRIZI.
• Do not use SKYRIZI if the prefilled syringe has been dropped or damaged.
• Do not use SKYRIZI if carton perforations are broken. Return product to the pharmacy.
• Do not remove the needle cover until right before giving the injections.

Keep SKYRIZI and all medicines out of the reach of children.
Please Read Complete Instructions For Use Before Using SKYRIZI Prefilled Syringe
Before Injecting:• Receive training on how to inject SKYRIZI before giving injections. Call your healthcare provider or(866) SKYRIZI or (866) 759-7494 if you need help.
• Mark your calendar ahead of time to remember when to take SKYRIZI.
• Leave the carton at room temperature and out of direct sunlight for 15 to 30 minutes to warm.
• Do not remove the prefilled syringes 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).

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Important Information:• The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
• Do not use SKYRIZI if the liquid is cloudy or contains flakes or large particles.
• Do not use SKYRIZI if the expiration date (EXP:) shown on the carton and prefilled syringe has
passed.
• Do not use SKYRIZI if the prefilled syringe has been dropped or damaged.
• Do not use SKYRIZI if carton perforations are broken. Return product to the pharmacy.

Storage Information:• Store SKYRIZI in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not shake SKYRIZI.
• Keep SKYRIZI in the original carton to protect from light until time to use.
• SKYRIZI is not made with natural rubber latex.
• Do not use if the liquid has been frozen (even if thawed).

Keep SKYRIZI and all medicines out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help or do not know how toproceed.

Gather the supplies for the injections and place the following
on a clean, flat surface:• 2 prefilled syringes and 2 alcohol swabs (included)• 2 cotton balls or gauze pads (not included)• FDA-cleared sharps disposal container (not included).
See “Used SKYRIZI Prefilled Syringe Disposal” for
information on how to throw away (dispose of) usedprefilled syringes.
Wash and dry your hands.
Start with 1 prefilled syringe for the first injection.

Reference ID: 5000374

Pick from the 3 injectable areas:• Front of left thigh or right thigh• Your abdomen (belly) at least 2 inches from your navel(belly button)

Wipe the injection site in a circular motion with the alcoholswab (before both injections)• Do not touch or blow on the injection site after it iscleaned. Allow the skin to dry before injecting.
• Do not inject through clothes.
• Do not inject into skin that is sore, bruised, red, hard,scarred, or has stretch marks, or into areas affected bypsoriasis.
Hold the prefilled syringe with the covered needle facing
down, as shown.
Check the liquid in the prefilled syringe.
• It is normal to see 1 or more bubbles in the window.
• The liquid should look clear to slightly yellow and may
contain tiny white or clear particles.
• Do not use the prefilled syringe if liquid is cloudy orcontains flakes or large particles.

Remove the needle cover.
• Hold the prefilled syringe in 1 hand between the finger
grip and needle cover.
• With the other hand, gently pull the needle cover straightoff.
• Do not hold or pull the plunger rod when removing theneedle cover.
• You may see a drop of liquid at the end of the needle.
This is normal.
• Throw away the needle cover.
• Do not touch the needle with your fingers or let theneedle touch anything.

Reference ID: 5000374

Hold the body of the prefilled syringe in 1 hand between the
thumb and index fingers.
Gently pinch the area of cleaned skin with your other handand hold it firmly.
Insert the needle into the skin at about a 45-degree angle
using a quick, short movement. Hold angle steady.

Slowly push the plunger rod all the way in until all of theliquid is injected, and the prefilled syringe is empty.
Pull the needle out of the skin while keeping the prefilled
syringe at the same angle.
Release the plunger rod and allow the prefilled syringe tomove up until the entire needle is covered by the needle
guard.
The prefilled syringe needle guard will not activate
unless all the liquid has been injected.
• Press a cotton ball or gauze pad over the injection siteand hold for 10 seconds.
• Do not rub the injection site. You may have slight
bleeding. This is normal.
Repeat Step 2 through Step 6 with the 2nd prefilled syringe
for a full dose.
• Use the 2nd prefilled syringe right after using the 1st
prefilled syringe.

Put your used prefilled syringes in a FDA-cleared sharps
disposal container right away after use.
• Do not throw away (dispose of) used prefilled syringes
in the household trash.
For more information, see “Used SKYRIZI Prefilled
Syringe Disposal” section.

Questions About Using SKYRIZIReference ID: 5000374

Q.
A.

What if I need help on how to inject SKYRIZI?
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help.

Q.
A.

What should I do with both used prefilled syringes after my injections?
Throw away (dispose of) both used prefilled syringes in a sharps disposal container and not yourhousehold trash.
You can sign up to receive sharps containers for SKYRIZI syringe disposal at no additional cost by
going to www.SKYRIZI.com or calling (866) SKYRIZI or (866) 759-7494.

Q.
A.

How do I know when the injection is complete?
The injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way
in, and the syringe needle guard is activated.

Used SKYRIZI Prefilled Syringe Disposal
If you do not have a FDA-cleared sharps disposal container, you may use a household containerthat 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 forthe 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, and for specific information about sharps disposal in thestate that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.

Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
© 2019-2022 AbbVie Inc.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 01/2022

Reference ID: 5000374

Instructions for Use
SKYRIZI® (sky-RIZZ-ee) On-Body Injector
risankizumab-rzaa
injection, for subcutaneous use only
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 ortreatment.
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.
Inject the medicine within 5 minutes 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 yourskin and are ready to inject.
o 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 cloudy or contains flakes or large particles. The liquid should lookclear 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.

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 andreturn the carton to the pharmacy.

Reference ID: 5000374

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

Reference ID: 5000374

Please read complete Instructions for Use before using SKYRIZI. Call your healthcare provider or (866) SKYRIZIor (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 readyBefore using SKYRIZI, you should receive training on how to inject SKYRIZI.
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.

Reference ID: 5000374

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.
 Do not warm SKYRIZI in any other way (forexample, do not warm it in a microwave or in
hot water).
Open the carton and remove the plastic tray
 Lift up the flap on the side of the carton.
 Take out the plastic tray.

Gather all supplies and wash hands
 Place the following on a clean surface:o plastic tray containing the On-Body
Injector and prefilled cartridge (included)o 2 alcohol wipes (not included)o cotton ball or gauze pad (not included)o sharps disposal container (not included)(see “Disposing of SKYRIZI”)
 Wash and dry your hands.

Remove the white paper tray seal
 Locate the black arrow.
 Peel away the white paper tray seal from theplastic 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 thepharmacy.

Lift the plastic cover Locate the rounded opening on the top cover.
 Insert your pointer finger in the opening andplace your thumb on the opposite side.
 Lift the cover to remove and set aside.

Reference ID: 5000374

Inspect the On-Body Injector
 Check that the On-Body Injector is intact andundamaged.
 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) andswing 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 withwater or any other liquids.



Do not touch the gray start button until it istime 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
Fully open the gray door

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



Reference ID: 5000374

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 toopen it.

Inspect the prefilled cartridge
 Carefully remove the prefilled cartridge fromthe plastic tray.
 Do not twist or remove cartridge top.
 Check the prefilled cartridge to make sure:o The expiration date (EXP:) has notpassed.
o The liquid should look clear to yellow andmay contain tiny white or clear particles.
It is normal to see one or more bubbles.
o 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 (evenif thawed).
 Do not use the prefilled cartridge if you dropit, discover missing pieces, or it is damaged.
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 thesmaller bottom tip of the prefilled cartridge.
 Do not touch the smaller bottom tip of theprefilled cartridge after cleaning.

Reference ID: 5000374

Load the cleaned prefilled cartridge into the
On-Body Injector
 Do not twist or remove the prefilled cartridgetop.


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.
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.

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
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 fromyour navel (belly button).

Reference ID: 5000374



The front of your left thigh or your right thigh.



Do not inject into areas of the skin thatnaturally 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 theexcessive hair from the injection area.

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.

Peel both tabs to expose adhesive Turn the On-Body Injector over to find bothgreen pull tabs.











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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 willremove the clear plastic strip, activating theOn-Body Injector.
Do not pull the adhesive material off the OnBody 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 OnBody 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.

Prepare the On-Body Injector for placement
 For the abdomen (belly), move and hold theskin to create a firm, flat surface for injection
at least 2 inches from your navel (belly
button). Make sure to adjust your posture (situp straight) to avoid skin folds and bulges.
You do not need to pull the skin flat for thefront of left thigh or right thigh.



Make sure to position the On-Body Injector sothat you can see the blue status light.

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 lightvisible.


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 isattached 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
Start injection
 Firmly press the gray start button until you
hear a click. Then release the gray start
button.

Reference ID: 5000374



Do not touch the gray start button until you
place the On-Body Injector loaded with theprefilled cartridge onto your skin and areready 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 willcontinuously flash green.

You will hear pumping sounds as the OnBody 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.

Wait for the injection to finish
 It may take up to 5 minutes to complete full
dose of medicine. The On-Body Injector willautomatically stop when the injection isfinished.
During the injection:othe status light will continue to flash green.

oyou will hear pumping sounds as the OnBody Injector continues delivering the
medicine.

omoderate 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 statuslight flashes red and beeps. Call (866)
SKYRIZI or (866) 759-7494.

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 haschanged to solid green, this means that the
injection is finished.
When the injection is finished, proceed to next
step.



Remove the On-Body Injector

Reference ID: 5000374















Do not put your fingers on the back side of
the On-Body Injector when removing it fromyour skin.
When the injection is done, grab the corner of
the adhesive to carefully peel the On-Body
Injector from the skin.
Avoid touching the needle cover or needle on
the back of the On-Body Injector.
After removing the On-Body Injector, you willhear several beeps and the status light willturn off.
The needle cover will cover the needle when
the On-Body Injector is removed from theskin.
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
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 lightturns off, letting you know that all the medicine
has been injected.
If the used white plunger does not fill thewindow, call (866) SKYRIZI or (866) 7597494.

Put the used On-Body Injector in an FDAcleared sharps disposal container right away
after use Leave the prefilled cartridge in the On-Body
Injector.

Reference ID: 5000374



Do not throw away (dispose of) the used OnBody Injector in your household trash.

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

Please read complete Instructions for Use before using SKYRIZI. Call your healthcare provider or (866) SKYRIZIor (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 thegreen pull tabs?
A. Peeling off small green pull tab will remove the clear plastic strip, activating the On-Body Injector. If all of theadhesive 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 lightremains 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.

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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 yourbody, 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 yourhousehold trash. You can receive a sharps container for SKYRIZI disposal at no additional cost by going towww.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.

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:o made of a heavy-duty plastic,o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
o upright and stable during use,o leak-resistant, ando 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 todispose of your sharps disposal container. There may be state or local laws about how you should throw away usedneedles 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.


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.
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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 iscomplete. 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 isoperating normally.
Emissions
Emissions test name

Test levels

Radiated Radio frequency electromagnetic fields

Per CISPR 11, class B

Electromagnetic Immunity
Test Name
Electrostatic discharge (ESD)Radio frequency electromagnetic field
Power frequency 50 Hz magnetic field

Test Levels± 8 kV contact± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
10 V/m80 MHz – 2.7 GHz
30 A/mThe enclosure port immunity to RF wireless communications equipment complies with IEC 60601-1-2:2014.

Glossary of symbols
SymbolDescription of Symbol
Keep dry

Sterilized using ethylene oxide

Do not re-use

Do not use if package is damaged and consult instructions for use

Date of manufacture

Batch code

Catalogue number

Serial number

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Refer to instruction manual / booklet

Type BF Applied Part

MR 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.
©2022 AbbVie Inc.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: 06/2022

Reference ID: 5000374