Drug Safety-related Labeling Changes (SrLC)

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SKYRIZI (BLA-761262)

(RISANKIZUMAB-RZAA)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/26/2026 (SUPPL-16)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Adverse Reactions in Adult Subjects with Psoriatic Arthritis

…

Adverse Reactions in Adult Subjects with Crohn’s Disease

…

Adverse Reactions in Adult Subjects with Ulcerative Colitis

…

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

…

Active Psoriatic Arthritis

The safety and effectiveness of SKYRIZI for the treatment of psoriatic arthritis have been established in pediatric patients 6 years of age and older.

Use of SKYRIZI for this indication is supported by evidence from well-controlled studies of SKYRIZI in adults with psoriatic arthritis, pharmacokinetic data from adult patients with psoriatic arthritis or plaque psoriasis, and pharmacokinetic, safety, and immunogenicity data from pediatric patients with moderate-to-severe plaque psoriasis [see Adverse Reactions (6.1), Clinical Pharmacology (12.3, 12.6), and Clinical Studies (14.2)]. Risankizumab exposures in pediatric patients with psoriatic arthritis at the recommended dosage are predicted to be comparable to those observed in adults with psoriatic arthritis based on population pharmacokinetic modeling and simulation.

The safety and effectiveness of SKYRIZI have not been established in pediatric patients younger than 6 years of age with psoriatic arthritis.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

What is SKYRIZI?

SKYRIZI is a prescription medicine used to treat:

• moderate to severe plaque psoriasis in adults and children 6 years of age and older who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

• active psoriatic arthritis in adults and children 6 years of age and older.

• moderate to severe Crohn’s disease in adults.

• moderate to severe ulcerative colitis in adults.

It is not known if SKYRIZI is safe and effective in children under 6 years of age with moderate to severe plaque psoriasis or active psoriatic arthritis.

…

How should I use SKYRIZI?

…

Adults and children 6 years of age and older with moderate to severe plaque psoriasis or active psoriatic arthritis will receive SKYRIZI as an injection under the skin (subcutaneous injection) using the prefilled pen or prefilled syringe.

Adults with moderately to severely active Crohn’s disease or moderately to severely active ulcerative colitis 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 1 or more injections under the skin (subcutaneous injection) using the prefilled cartridge with on-body injector or prefilled syringe.

06/12/2026 (SUPPL-15)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Adverse Reactions in Adults with Plaque Psoriasis

A total of 2234 adults were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with plaque psoriasis were exposed to SKYRIZI for at least one year.

. . .

Adverse Reactions in Pediatric Subjects 6 Years of Age and Older with Plaque Psoriasis

The safety of SKYRIZI was evaluated in a four-part trial that included 137 pediatric subjects 6 years of age and older with moderate-to-severe plaque psoriasis [see Clinical Studies (14.1)]. Overall, the safety profile observed in pediatric subjects 6 years of age and older treated with SKYRIZI for up to 52 weeks was consistent with the safety profile observed in adult subjects with moderate-to-severe plaque psoriasis.

. . .

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

Moderate-to-Severe Plaque Psoriasis

 

The safety and effectiveness of SKYRIZI for the treatment of moderate-to-severe plaque psoriasis have been established in pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy.

Use of SKYRIZI for this indication is supported by evidence from a four-part trial in a total of 137 pediatric subjects 6 years of age and older with moderate-to-severe plaque psoriasis. In addition to two lead-in pharmacokinetic cohorts, the trial also included a randomized, efficacy assessor-blinded, active treatment-controlled cohort that enrolled 82 pediatric subjects 12 years of age and older and a single-arm, open-label cohort that enrolled 30 pediatric subjects 6 to less than 12 years of age [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)].

The safety and effectiveness of SKYRIZI have not been established in pediatric patients younger than 6 years of age with moderate-to-severe plaque psoriasis.

 

Psoriatic Arthritis, Crohn’s Disease, and Ulcerative Colitis

 

The safety and effectiveness of SKYRIZI have not been established in pediatric patients with psoriatic arthritis, Crohn’s disease or ulcerative colitis.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

For pediatric patients, inform patients and caregivers that for pediatric patients 10 years of age and older, it is recommended that SKYRIZI be administered by or under supervision of an adult. For pediatric patients 6 to less than 10 years of age, SKYRIZI should be administered by an adult [see Dosage and Administration (2.5)].

. . .

 

MEDICATION GUIDE

Additions and/or revisions underlined:

. . .

What is SKYRIZI?

SKYRIZI is a prescription medicine used to treat:

• moderate to severe plaque psoriasis in adults and children 6 years of age and older 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.

• moderate to severe ulcerative colitis in adults.

  It is not known if SKYRIZI is safe and effective in children under 6 years of age with moderate to severe plaque psoriasis.

  It is not known if SKYRIZI is safe and effective in children with psoriatic arthritis, Crohn’s disease, or ulcerative colitis.

  . . .

• For children 6 years of age and older:

  • In children 10 years of age and older, it is recommended that SKYRIZI prefilled pen or prefilled syringe be given by an adult or with an adult watching (supervision).

  • In children 6 years to less than 10 years of age, SKYRIZI should be given by an adult.

    . . .

    Adults and children 6 years of age and older with moderate to severe plaque psoriasis or adults with psoriatic arthritis will receive SKYRIZI as an injection under the skin (subcutaneous injection) using the prefilled pen or prefilled syringe.

    . . .

03/06/2026 (SUPPL-14)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

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 this period, serious infections that led to trial discontinuation included pneumonia.

Plaque Psoriasis of the Scalp or Genital Area

The overall safety profile observed in clinical trials of subjects with moderate to severe plaque psoriasis of the scalp or genital area treated with SKYRIZI is generally consistent with the safety profile observed in previous clinical trials of subjects with moderate to severe plaque psoriasis [see Clinical Studies (14.1)].

. . .

6.2 Immunogenicity

Additions and/or revisions underlined:

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies (ADA) in the trials described below with the incidence of ADA in other trials, including those of SKYRIZI (risankizumab).

. . .

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

. . .

Clinical Considerations

Disease-associated maternal and embryo/fetal risk

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

Fetal/Neonatal adverse reactions

Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, SKYRIZI may be present in infants exposed in utero. The potential clinical impact of risankizumab exposure in infants exposed in utero should be considered.

. . .

09/03/2025 (SUPPL-11)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Administration Instruction

…

If using SKYRIZI 90 mg/mL, instruct patients or caregivers to administer two 90 mg single-dose syringes to achieve the full 180 mg maintenance dose or four 90 mg single-dose syringes to achieve the full 360 mg maintenance dose of SKYRIZI for Crohn’s disease or ulcerative colitis [see Instructions for Use].

If using SKYRIZI 180 mg/1.2 mL, instruct patients or caregivers to administer one 180 mg single-dose syringe to achieve the full 180 mg maintenance dose or two 180 mg single-dose syringes to achieve the full 360 mg maintenance dose of SKYRIZI for Crohn’s disease or ulcerative colitis [see Instructions for Use].

…

MEDICATION GUIDE

Additions and/or revisions:

What are the ingredients in SKYRIZI? Active ingredient: risankizumab-rzaa.

SKYRIZI 90 mg/mL prefilled syringe inactive ingredients: polysorbate 20, sodium succinate,

sorbitol, succinic acid, and Water for Injection, USP.

SKYRIZI 150 mg/mL prefilled pen or prefilled syringe, 180 mg/1.2 mL prefilled syringe or prefilled cartridge, 360 mg/2.4 mL prefilled cartridge, and 600 mg/ 10 mL vial inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate, trehalose, and Water for Injection, USP.

06/18/2024 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Hepatotoxicity in Treatment of Inflammatory Bowel Disease

Subsection title revised

Additions and revisions underlined:

. . .

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

. . .

6 Adverse Reactions

Additions and revisions underlined:

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 Inflammatory Bowel Disease [see Warnings and Precautions (5.4)]

6.1 Clinical Trials Experience

Extensive changes; please refer to label

6.2 Immunogenicity

Newly added information:

By Week 64, antibodies to risankizumab-rzaa developed in approximately 8.9% (8/90) or 4.4% (4/91) of subjects treated with SKYRIZI induction followed by the 180 mg or 360 mg maintenance regimen, respectively. Of the subjects who developed antibodies to risankizumab- rzaa, 75% (6.7% of all subjects treated with SKYRIZI induction followed by the 180 mg maintenance regimen) or 50% (2.2% of all subjects treated with SKYRIZI induction followed by the 360 mg maintenance regimen), respectively, had antibodies that were classified as neutralizing.

8 Use in Specific Populations

8.1 Pregnancy

Additions and revisions underlined:

. . .

The 50 mg/kg dose in pregnant monkeys resulted in approximately 5 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 32 times the exposure (AUC) to the maximum recommended maintenance dose (360 mg).

. . .

The 5 mg/kg dose in pregnant monkeys resulted in approximately 0.6 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 5 times the exposure (AUC) in humans administered the maximum recommended maintenance dose (360 mg).

. . .

8.5 Geriatric Use

Additions and revisions underlined:

Of the 6,862 subjects exposed to SKYRIZI, a total of 664 were 65 years or older (243 subjects with plaque psoriasis, 246 subjects with psoriatic arthritis, 72 subjects with Crohn’s disease and 103 subjects with ulcerative colitis), and 71 subjects were 75 years or older.

Clinical studies of SKYRIZI, within each indication, did not include sufficient numbers 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 were observed based on age[see Clinical Pharmacology (12.3)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Medication Guide

Additions and revisions underlined:

SKYRIZI is a prescription medicine used to treat:

• moderate to severe ulcerative colitis in adults.

  . . .

Adults with Crohn’s disease or ulcerative colitis will receive their starter doses with SKYRIZI through a

vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider.

. . .

• Liver problems may happen while being treated for Crohn’s disease or ulcerative colitis. 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.

The most common side effects of SKYRIZI in people treated for Crohn’s disease and ulcerative

colitis include:

• upper respiratory infections

• headache

• stomach (abdominal) pain

• injection site reactions

• fever

• back pain

• joint pain • low red blood cells (anemia) • urinary tract infection

• rash

PATIENT COUNSELING INFORMATION

Subsection title revised

Hepatotoxicity in Treatment of Inflammatory Bowel Disease

01/03/2024 (SUPPL-5)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

…

What are the ingredients in SKYRIZI? Active ingredient: risankizumab-rzaa.

SKYRIZI 75 mg/0.83 mL and 90 mg/mL inactive ingredients: polysorbate 20, sodium succinate, sorbitol, succinic acid, and Water for Injection, USP.

SKYRIZI 150 mg/mL, 180 mg/1.2 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.

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Administration Instruction

Instruct patients or caregivers to perform the first self-injected dose under the supervision and guidance 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].

If using SKYRIZI 90 mg/mL, a healthcare professional must administer two 90 mg single-dose syringes to achieve the full 180 mg maintenance dose or four 90 mg single-dose syringes to achieve the full 360 mg maintenance dose of SKYRIZI for Crohn’s disease.

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 [see Use in Specific Populations (8.1)].

09/23/2022 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Crohn’s Disease

… 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 Clinical Studies (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 at Weeks 0, 4 and 8. In the maintenance study (CD-3), 297 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 a maintenance regimen of SKYRIZI either 180 mg or 360 mg subcutaneously at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks.

Adverse reactions reported in > 3% of subjects in induction studies and at a higher rate than placebo are shown in Table 2.

Specific Adverse Drug Reactions

Infections

In the maintenance study (CD-3) through Week 52, the rate of infections was 32.3% (50.2 events per 100 subject-years) in subjects who received SKYRIZI 180 mg and 36.6% (60.8 events per 100 subject-years) in subjects who received SKYRIZI 360 mg compared to 36.4% (60.3 events per 100 subject-years) in subjects who received placebo after SKYRIZI induction. The rate of serious infections was 2.6% (2.7 events per 100 subject-years) in subjects who received SKYRIZI 180 mg and 5.6% (7.4 events per 100 subject-years) in subjects who received SKYRIZI 360 mg compared to 2.1% (2.4 events per 100 subject-years) in subjects who received placebo after SKYRIZI induction.

Lipid Elevations

… 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 at Week 12. Mean LDL-C increased by 3.1 mg/dL from baseline to a mean absolute value of 99.0 mg/dL at Week 52 with SKYRIZI 180 mg maintenance treatment and by 2.3 mg/dL from baseline to a mean absolute value of 102.2 mg/dL at Week 52 with SKYRIZI 360 mg maintenance treatment.

6.2 Immunogenicity

Additions and/or revisions underlined:

Crohn’s Disease

By Week 64, antibodies to risankizumab-rzaa developed in approximately 3.4% (2/58) of subjects treated with SKYRIZI induction followed by 360 mg maintenance regimen. No subjects (0/57) treated with SKYRIZI induction followed by 180 mg maintenance regimen developed antibodies to risankizumab-rzaa. None of the subjects who developed antibodies to risankizumab-rzaa had antibodies that were classified as neutralizing.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

What are the ingredients in SKYRIZI? Active ingredient: risankizumab-rzaa.

SKYRIZI 75 mg/0.83 mL inactive ingredients: sodium succinate, polysorbate 20, sorbitol, succinic acid, and Water for Injection, USP.

SKYRIZI 150 mg/mL, 180 mg/1.2 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.